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Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)

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ClinicalTrials.gov Identifier: NCT02764541
Recruitment Status : Active, not recruiting
First Posted : May 6, 2016
Results First Posted : August 31, 2023
Last Update Posted : March 20, 2024
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Otto Metzger, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Letrozole
Drug: Tamoxifen
Drug: Palbociclib
Drug: Endocrine Therapy
Enrollment 195
Recruitment Details  
Pre-assignment Details Three patients withdrew consent before receiving intervention
Arm/Group Title Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib Arm A Tamoxifen First, Then Arm D Endocrine Alone Arm B Letrozole First, Then Arm C Endocrine With Palbociclib Arm B Letrozole First, Then Arm D Endocrine Alone Arm A Tamoxifen Only Arm B Letrozole Only Arm C Endocrine With Palbociclib Only Arm D Endocrine Alone Only
Hide Arm/Group Description Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks Tamoxifen is given in the window phase for 2 weeks Letrozole is given in the window phase for 2 weeks Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks Endocrine therapy alone is given in the treatment phase for 24 weeks
Period Title: Overall Study
Started 36 21 37 19 1 2 55 21
Completed 33 20 36 16 0 0 52 18
Not Completed 3 1 1 3 1 2 3 3
Reason Not Completed
Withdrawal by Subject             0             0             0             0             1             1             0             1
Adverse Event             1             0             0             0             0             0             1             0
Metastasis             1             0             0             0             0             0             0             0
Disease progression             1             1             0             0             0             0             0             1
Protocol Violation             0             0             0             1             0             1             0             0
Physician Decision             0             0             0             1             0             0             0             1
Three Cycles completed before surgery             0             0             0             1             0             0             0             0
Patient Compliance             0             0             1             0             0             0             0             0
Death             0             0             0             0             0             0             1             0
Insurance reasons             0             0             0             0             0             0             1             0
Arm/Group Title Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib Arm A Tamoxifen First, Then Arm D Endocrine Alone Arm B Letrozole First, Then Arm C Endocrine With Palbociclib Arm B Letrozole First, Then Arm D Endocrine Alone Arm A Tamoxifen Only Arm B Letrozole Only Arm C Endocrine With Palbociclib Only Arm D Endocrine Alone Only Total
Hide Arm/Group Description Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks. Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks. Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks. Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks. Tamoxifen is given in the window phase for 2 weeks Letrozole is given in the window phase for 2 weeks Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks Endocrine therapy alone is given in the treatment phase for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 36 21 37 19 1 2 55 21 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
64.0
(42.0 to 81.0)
62.0
(53.0 to 80.0)
64.0
(51.0 to 83.0)
65.0
(50.0 to 77.0)
56.0
(56.0 to 56.0)
62.0
(58.0 to 66.0)
49.0
(32.0 to 75.0)
48.0
(33.0 to 56.0)
57.0
(32.0 to 83.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
Female
36
 100.0%
21
 100.0%
37
 100.0%
19
 100.0%
1
 100.0%
2
 100.0%
55
 100.0%
21
 100.0%
192
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
Hispanic or Latino
0
   0.0%
1
   4.8%
1
   2.7%
1
   5.3%
0
   0.0%
0
   0.0%
3
   5.5%
2
   9.5%
8
   4.2%
Not Hispanic or Latino
33
  91.7%
19
  90.5%
33
  89.2%
17
  89.5%
1
 100.0%
2
 100.0%
48
  87.3%
19
  90.5%
172
  89.6%
Unknown or Not Reported
3
   8.3%
1
   4.8%
3
   8.1%
1
   5.3%
0
   0.0%
0
   0.0%
4
   7.3%
0
   0.0%
12
   6.3%
Race  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
Black or African American
5
  13.9%
0
   0.0%
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
3
   5.5%
2
   9.5%
11
   5.7%
White
31
  86.1%
20
  95.2%
33
  89.2%
18
  94.7%
1
 100.0%
2
 100.0%
47
  85.5%
17
  81.0%
169
  88.0%
Asian
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
   3.6%
0
   0.0%
3
   1.6%
More than one race
0
   0.0%
1
   4.8%
1
   2.7%
1
   5.3%
0
   0.0%
0
   0.0%
2
   3.6%
2
   9.5%
7
   3.6%
Other
0
   0.0%
0
   0.0%
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
2
   1.0%
Menopausal Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
Post-menopausal
35
  97.2%
21
 100.0%
37
 100.0%
19
 100.0%
1
 100.0%
2
 100.0%
8
  14.5%
0
   0.0%
123
  64.1%
Pre-menopausal
1
   2.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
47
  85.5%
21
 100.0%
69
  35.9%
Baseline Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
Invasive Ductal
14
  38.9%
11
  52.4%
19
  51.4%
10
  52.6%
0
   0.0%
0
   0.0%
29
  52.7%
9
  42.9%
92
  47.9%
Invasive Lobular
21
  58.3%
7
  33.3%
17
  45.9%
9
  47.4%
0
   0.0%
2
 100.0%
19
  34.5%
9
  42.9%
84
  43.8%
Both
1
   2.8%
3
  14.3%
1
   2.7%
0
   0.0%
1
 100.0%
0
   0.0%
7
  12.7%
2
   9.5%
15
   7.8%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
1
   0.5%
Baseline clinical N stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
N0
19
  52.8%
11
  52.4%
19
  51.4%
10
  52.6%
1
 100.0%
2
 100.0%
28
  50.9%
12
  57.1%
102
  53.1%
N1
17
  47.2%
9
  42.9%
17
  45.9%
8
  42.1%
0
   0.0%
0
   0.0%
21
  38.2%
9
  42.9%
81
  42.2%
N2
0
   0.0%
1
   4.8%
1
   2.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
3
   1.6%
N3
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.5%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
4
   7.3%
0
   0.0%
5
   2.6%
[1]
Measure Description: This is based on the diagnostic test and shows the extent the tumor spread to the lymph nodes. Higher stage is associated with worse outcome.
Baseline clinical T stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
T1a
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
T1b
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
1
   0.5%
T1c
6
  16.7%
2
   9.5%
2
   5.4%
2
  10.5%
0
   0.0%
0
   0.0%
3
   5.5%
2
   9.5%
17
   8.9%
T2
20
  55.6%
12
  57.1%
21
  56.8%
13
  68.4%
1
 100.0%
2
 100.0%
34
  61.8%
11
  52.4%
114
  59.4%
T3
8
  22.2%
5
  23.8%
12
  32.4%
4
  21.1%
0
   0.0%
0
   0.0%
15
  27.3%
8
  38.1%
52
  27.1%
T4
2
   5.6%
0
   0.0%
2
   5.4%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
5
   2.6%
Unknown
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.8%
0
   0.0%
2
   1.0%
[1]
Measure Description: This is based on the diagnostic test and describes the size and location of the tumor. Higher stage is associated with worse outcome.
Baseline Invasive Primary Breast Cancer Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
I
4
  11.1%
2
   9.5%
2
   5.4%
1
   5.3%
0
   0.0%
0
   0.0%
6
  10.9%
0
   0.0%
15
   7.8%
II
26
  72.2%
17
  81.0%
27
  73.0%
18
  94.7%
1
 100.0%
2
 100.0%
44
  80.0%
19
  90.5%
154
  80.2%
III
6
  16.7%
2
   9.5%
8
  21.6%
0
   0.0%
0
   0.0%
0
   0.0%
5
   9.1%
2
   9.5%
23
  12.0%
[1]
Measure Description: This stage was assigned by combining the tumor size/location, node, metastasis, tumor grade, and the results of ER/PR and HER2 testing results. Higher stage is associated with worse outcome.
Surgery Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 21 participants 37 participants 19 participants 1 participants 2 participants 55 participants 21 participants 192 participants
Breast Conservation/Lumpectomy
17
  47.2%
10
  47.6%
20
  54.1%
12
  63.2%
0
   0.0%
0
   0.0%
21
  38.2%
5
  23.8%
85
  44.3%
Mastectomy
17
  47.2%
10
  47.6%
17
  45.9%
5
  26.3%
0
   0.0%
0
   0.0%
31
  56.4%
13
  61.9%
93
  48.4%
Missing
2
   5.6%
1
   4.8%
0
   0.0%
2
  10.5%
1
 100.0%
2
 100.0%
3
   5.5%
3
  14.3%
14
   7.3%
1.Primary Outcome
Title Difference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phase
Hide Description Log fold change in anti-proliferative activity of Letrozole versus Tamoxifen within cohorts of hormone receptor positive breast cancer for patients with invasive lobular and ductal carcinoma during the window phase. Higher absolute value indicates larger change in the anti-proliferative activity
Time Frame baseline to day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Patients both not missing baseline and day15 Ki67 were included into the analysis population
Arm/Group Title Tamoxifen With Invasive Ductal Letrozole With Invasive Ductal Tamoxifen With Invasive Lobular Letrozole With Invasive Lobular
Hide Arm/Group Description:
Patients with invasive ductal/both histology receiving Tamoxifen in the window phase
Patients with invasive ductal/both histology receiving Letrozole in the window phase
Patients with invasive lobular histology receiving Tamoxifen in the window phase
Patients with invasive lobular histology receiving Letrozole in the window phase
Overall Number of Participants Analyzed 27 28 25 25
Mean (Standard Deviation)
Unit of Measure: log fold-change
-0.180  (2.5) -1.304  (2.2) -0.635  (2.5) -1.944  (2.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tamoxifen With Invasive Ductal, Letrozole With Invasive Ductal
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive ductal carcinoma
Statistical Test of Hypothesis P-Value 0.0045
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Tamoxifen With Invasive Lobular, Letrozole With Invasive Lobular
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The hypothesis is that there is no difference in anti-proliferative activity of Letrozole vs Tamoxifen by measuring the fold-change in percent Ki67 from baseline to day15 in log scale within hormone receptor positive breast cancer patients with invasive lobular carcinoma
Statistical Test of Hypothesis P-Value 0.0161
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Pathologic Complete Response (pCR) of Patients Given Endocrine Therapy Plus Palbociclib and of Endocrine Therapy Alone During the Treatment Phase
Hide Description Residual Cancer Burden index (RCB) between hormone receptor positive invasive breast cancer patients given endocrine therapy plus palbociclib (Arm C) and endocrine therapy alone (Arm D). RCB score is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to infinity. Higher RCB score indicates more tumor burden remaining, thus worse outcome.
Time Frame day 15 to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with treatment and surgery are included into the analysis population
Arm/Group Title Arm C Endocrine With Palbociclib Arm D Endocrine Therapy Alone
Hide Arm/Group Description:
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks.
Endocrine therapy alone is given in the treatment phase for 24 weeks
Overall Number of Participants Analyzed 128 60
Mean (Full Range)
Unit of Measure: score on a scale
2.88
(0.00 to 4.83)
2.88
(0.03 to 4.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm C Endocrine With Palbociclib, Arm D Endocrine Therapy Alone
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D
Statistical Test of Hypothesis P-Value 0.9288
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Odds Ratio of Achieving Cell Cycle Arrest at the End of Window Phase
Hide Description Odds Ratio of Achieving Cell Cycle Arrest at the end of Window Phase in hormone receptor positive invasive breast cancer patients given Tamoxifen vs Letrozole. Cell cycle arrest is defined to be percentage of Ki67<2.7
Time Frame baseline to day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Patients both not missing baseline and day15 Ki67 were included into the analysis population
Arm/Group Title Tamoxifen vs Letrozole in Invasive Ductal Patients Tamoxifen vs Letrozole in Invasive Lobular Patients
Hide Arm/Group Description:
Patients with invasive ductal/both histology receiving Tamoxifen vs Letrozole in the window phase
Patients with invasive lobular histology receiving Tamoxifen vs Letrozole in the window phase
Overall Number of Participants Analyzed 55 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds ratio
0.26
(0.08 to 0.89)
0.60
(0.19 to 1.9)
4.Secondary Outcome
Title Change in RCB Index Between Arm C and Arm D During the Treatment Phase
Hide Description The estimate of RCB index change for patients who receive both endocrine and Palbociclib instead of endocrine alone, but have the same lymph node status, tumor size and menopausal status. RCB score is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to infinity. Higher RCB score indicates more tumor burden remaining, thus worse outcome.
Time Frame day 15 to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with treatment and surgery are included into the analysis population
Arm/Group Title Endocrine With Palbociclib Endocrine Alone
Hide Arm/Group Description:
Endocrine therapy in combination with Palbociclib
Endocrine therapy alone
Overall Number of Participants Analyzed 128 60
Mean (Full Range)
Unit of Measure: units on a scale
2.88
(0.00 to 4.83)
2.88
(0.03 to 4.71)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endocrine With Palbociclib, Endocrine Alone
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The hypothesis is that there is no difference of pathologic response measured by RCB index between Arm C and Arm D
Statistical Test of Hypothesis P-Value 0.920
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.29 to 0.32
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Participants With RCB Response in Arm C and Arm D During the Treatment Phase
Hide Description RCB response is defined as RCB-0 or RCB-I; RCB not response is defined as RCB-II or RCB-III Residual Cancer Burden (RCB) considers residual disease in the tumor bed and lymph nodes after NAC, generating a continuous score which is then grouped into four categories: RCB-0, RCB-I, RCB-II and RCB-III. Higher RCB group reflects more tumor burden remaining, thus worse outcome
Time Frame day 15 to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with treatment and surgery are included into the analysis population
Arm/Group Title Arm C Endocrine With Palbociclib Arm D Endocrine Therapy Alone
Hide Arm/Group Description:
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks.
Endocrine therapy alone is given in the treatment phase for 24 weeks
Overall Number of Participants Analyzed 128 60
Measure Type: Count of Participants
Unit of Measure: Participants
10
   7.8%
3
   5.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm C Endocrine With Palbociclib, Arm D Endocrine Therapy Alone
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The hypothesis is that there is no difference of RCB response rate between Arm C and Arm D
Statistical Test of Hypothesis P-Value 0.758
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Clinical Response in Arm C and Arm D in the Treatment Phase
Hide Description Percentage of Participants with Clinical Response in Arm C and Arm D in Breast cancer patients diagnosed with hormone receptor positive invasive breast cancer; Clinical response rate is defined as the number of partial and complete responses after preoperative endocrine therapy plus palbociclib (Arm C) and of endocrine therapy alone (Arm D)
Time Frame day 15 to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with treatment and surgery are included into the analysis population
Arm/Group Title Arm C Endocrine With Palbociclib Arm D Endocrine Therapy Alone
Hide Arm/Group Description:
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks.
Endocrine therapy alone is given in the treatment phase for 24 weeks
Overall Number of Participants Analyzed 128 60
Measure Type: Number
Unit of Measure: percentage of participants
57.8 43.3
Time Frame The adverse event data were collected after starting the first dose of study treatment and before 30 days following the last administration of study treatment or study discontinuation/termination (up to 27 weeks), whichever is earlier.
Adverse Event Reporting Description Serious AEs are defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. AEs were collected without specifying which phase they occurred in and are reported by patients' treatment sequence, which is consistent with the participant flow and considered as the most feasible way.
 
Arm/Group Title Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib Arm A Tamoxifen First, Then Arm D Endocrine Alone Arm B Letrozole First, Then Arm C Endocrine With Palbociclib Arm B Letrozole First, Then Arm D Endocrine Alone Arm A Tamoxifen Only Arm B Letrozole Only Arm C Endocrine With Palbociclib Only Arm D Endocrine Alone Only
Hide Arm/Group Description Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks Tamoxifen is given in the window phase for 2 weeks Letrozole is given in the window phase for 2 weeks Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks Endocrine therapy alone is given in the treatment phase for 24 weeks
All-Cause Mortality
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib Arm A Tamoxifen First, Then Arm D Endocrine Alone Arm B Letrozole First, Then Arm C Endocrine With Palbociclib Arm B Letrozole First, Then Arm D Endocrine Alone Arm A Tamoxifen Only Arm B Letrozole Only Arm C Endocrine With Palbociclib Only Arm D Endocrine Alone Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/36 (2.78%)   2/21 (9.52%)   0/37 (0.00%)   1/19 (5.26%)   0/1 (0.00%)   0/2 (0.00%)   3/55 (5.45%)   1/21 (4.76%) 
Hide Serious Adverse Events
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib Arm A Tamoxifen First, Then Arm D Endocrine Alone Arm B Letrozole First, Then Arm C Endocrine With Palbociclib Arm B Letrozole First, Then Arm D Endocrine Alone Arm A Tamoxifen Only Arm B Letrozole Only Arm C Endocrine With Palbociclib Only Arm D Endocrine Alone Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/36 (8.33%)   3/21 (14.29%)   14/37 (37.84%)   0/19 (0.00%)   0/1 (0.00%)   0/2 (0.00%)   21/55 (38.18%)   0/21 (0.00%) 
Blood and lymphatic system disorders                 
Blood and lymphatic system disorders - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Febrile neutropenia † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/55 (1.82%)  0/21 (0.00%) 
Gastrointestinal disorders                 
Constipation † 1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Mucositis oral † 1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/55 (1.82%)  0/21 (0.00%) 
General disorders                 
Fatigue † 1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/55 (1.82%)  0/21 (0.00%) 
Investigations                 
Neutrophil count decreased † 1  3/36 (8.33%)  0/21 (0.00%)  13/37 (35.14%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  18/55 (32.73%)  0/21 (0.00%) 
White blood cell decreased † 1  1/36 (2.78%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Lymphocyte count decreased † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/55 (1.82%)  0/21 (0.00%) 
Nervous system disorders                 
Syncope † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/55 (1.82%)  0/21 (0.00%) 
Psychiatric disorders                 
Insomnia † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/55 (1.82%)  0/21 (0.00%) 
Reproductive system and breast disorders                 
Premature menopause † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  1/55 (1.82%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders                 
Rash maculo-papular † 1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Urticaria † 1  0/36 (0.00%)  1/21 (4.76%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Vascular disorders                 
Hypertension † 1  0/36 (0.00%)  0/21 (0.00%)  1/37 (2.70%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib Arm A Tamoxifen First, Then Arm D Endocrine Alone Arm B Letrozole First, Then Arm C Endocrine With Palbociclib Arm B Letrozole First, Then Arm D Endocrine Alone Arm A Tamoxifen Only Arm B Letrozole Only Arm C Endocrine With Palbociclib Only Arm D Endocrine Alone Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   36/36 (100.00%)   21/21 (100.00%)   37/37 (100.00%)   18/19 (94.74%)   0/1 (0.00%)   1/2 (50.00%)   55/55 (100.00%)   19/21 (90.48%) 
Blood and lymphatic system disorders                 
Anemia † 1  6/36 (16.67%)  0/21 (0.00%)  4/37 (10.81%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  6/55 (10.91%)  0/21 (0.00%) 
Febrile neutropenia † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  0/21 (0.00%) 
Cardiac disorders                 
Cardiac disorders - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Restrictive cardiomyopathy † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Ear and labyrinth disorders                 
Tinnitus † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Ear and labyrinth disorders - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Ear pain † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Endocrine disorders                 
Hypothyroidism † 1  5/36 (13.89%)  2/21 (9.52%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Eye disorders                 
Blurred vision † 1  2/36 (5.56%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Cataract † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Dry eye † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Eye disorders - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  2/21 (9.52%) 
Gastrointestinal disorders                 
Constipation † 1  8/36 (22.22%)  2/21 (9.52%)  5/37 (13.51%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  9/55 (16.36%)  4/21 (19.05%) 
Diarrhea † 1  8/36 (22.22%)  4/21 (19.05%)  7/37 (18.92%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  15/55 (27.27%)  0/21 (0.00%) 
Dry mouth † 1  3/36 (8.33%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Gastroesophageal reflux disease † 1  9/36 (25.00%)  2/21 (9.52%)  7/37 (18.92%)  6/19 (31.58%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  0/21 (0.00%) 
Gastrointestinal disorders - Other, specify † 1  2/36 (5.56%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Mucositis oral † 1  10/36 (27.78%)  0/21 (0.00%)  10/37 (27.03%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  15/55 (27.27%)  0/21 (0.00%) 
Nausea † 1  13/36 (36.11%)  5/21 (23.81%)  7/37 (18.92%)  3/19 (15.79%)  0/1 (0.00%)  0/2 (0.00%)  14/55 (25.45%)  2/21 (9.52%) 
Vomiting † 1  3/36 (8.33%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Bloating † 1  0/36 (0.00%)  2/21 (9.52%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Dyspepsia † 1  0/36 (0.00%)  2/21 (9.52%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Oral pain † 1  0/36 (0.00%)  0/21 (0.00%)  3/37 (8.11%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Rectal hemorrhage † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Abdominal pain † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  3/21 (14.29%) 
General disorders                 
Chills † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Fatigue † 1  27/36 (75.00%)  9/21 (42.86%)  26/37 (70.27%)  10/19 (52.63%)  0/1 (0.00%)  1/2 (50.00%)  34/55 (61.82%)  6/21 (28.57%) 
Fever † 1  4/36 (11.11%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
General disorders and administration site conditions - Other, specify † 1  7/36 (19.44%)  3/21 (14.29%)  9/37 (24.32%)  6/19 (31.58%)  0/1 (0.00%)  0/2 (0.00%)  8/55 (14.55%)  0/21 (0.00%) 
Pain † 1  5/36 (13.89%)  4/21 (19.05%)  3/37 (8.11%)  4/19 (21.05%)  0/1 (0.00%)  0/2 (0.00%)  6/55 (10.91%)  5/21 (23.81%) 
Edema limbs † 1  0/36 (0.00%)  5/21 (23.81%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Flu like symptoms † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Localized edema † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Malaise † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Infections and infestations                 
Breast infection † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Sinusitis † 1  3/36 (8.33%)  0/21 (0.00%)  4/37 (10.81%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  0/21 (0.00%) 
Skin infection † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Upper respiratory infection † 1  4/36 (11.11%)  0/21 (0.00%)  3/37 (8.11%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Urinary tract infection † 1  2/36 (5.56%)  0/21 (0.00%)  3/37 (8.11%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Infections and infestations - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  3/37 (8.11%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  2/21 (9.52%) 
Injury, poisoning and procedural complications                 
Bruising † 1  0/36 (0.00%)  0/21 (0.00%)  3/37 (8.11%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Investigations                 
Alanine aminotransferase increased † 1  2/36 (5.56%)  0/21 (0.00%)  3/37 (8.11%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Aspartate aminotransferase increased † 1  3/36 (8.33%)  0/21 (0.00%)  3/37 (8.11%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Cholesterol high † 1  2/36 (5.56%)  2/21 (9.52%)  3/37 (8.11%)  5/19 (26.32%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Creatinine increased † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Neutrophil count decreased † 1  28/36 (77.78%)  0/21 (0.00%)  23/37 (62.16%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  43/55 (78.18%)  0/21 (0.00%) 
Platelet count decreased † 1  5/36 (13.89%)  0/21 (0.00%)  4/37 (10.81%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  9/55 (16.36%)  0/21 (0.00%) 
White blood cell decreased † 1  5/36 (13.89%)  0/21 (0.00%)  3/37 (8.11%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  12/55 (21.82%)  0/21 (0.00%) 
Blood prolactin abnormal † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Weight gain † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders                 
Anorexia † 1  3/36 (8.33%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Glucose intolerance † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Hypoalbuminemia † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Metabolism and nutrition disorders - Other, specify † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Hypokalemia † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  0/21 (0.00%) 
Hyperglycemia † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  6/55 (10.91%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Arthralgia † 1  8/36 (22.22%)  9/21 (42.86%)  11/37 (29.73%)  6/19 (31.58%)  0/1 (0.00%)  0/2 (0.00%)  10/55 (18.18%)  2/21 (9.52%) 
Arthritis † 1  4/36 (11.11%)  2/21 (9.52%)  0/37 (0.00%)  4/19 (21.05%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Back pain † 1  3/36 (8.33%)  0/21 (0.00%)  4/37 (10.81%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  7/55 (12.73%)  4/21 (19.05%) 
Generalized muscle weakness † 1  3/36 (8.33%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Joint range of motion decreased † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, specify † 1  2/36 (5.56%)  0/21 (0.00%)  5/37 (13.51%)  3/19 (15.79%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Myalgia † 1  7/36 (19.44%)  5/21 (23.81%)  6/37 (16.22%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  5/55 (9.09%)  3/21 (14.29%) 
Osteoporosis † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  2/19 (10.53%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Pain in extremity † 1  4/36 (11.11%)  2/21 (9.52%)  3/37 (8.11%)  4/19 (21.05%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Bone pain † 1  0/36 (0.00%)  2/21 (9.52%)  3/37 (8.11%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Neck pain † 1  0/36 (0.00%)  2/21 (9.52%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Nervous system disorders                 
Dizziness † 1  5/36 (13.89%)  3/21 (14.29%)  4/37 (10.81%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  11/55 (20.00%)  0/21 (0.00%) 
Headache † 1  8/36 (22.22%)  5/21 (23.81%)  6/37 (16.22%)  3/19 (15.79%)  0/1 (0.00%)  0/2 (0.00%)  20/55 (36.36%)  4/21 (19.05%) 
Memory impairment † 1  0/36 (0.00%)  2/21 (9.52%)  2/37 (5.41%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Peripheral sensory neuropathy † 1  0/36 (0.00%)  2/21 (9.52%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  2/21 (9.52%) 
Sinus pain † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Stroke † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Nervous system disorders - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Peripheral motor neuropathy † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Cognitive disturbance † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Dysgeusia † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  0/21 (0.00%) 
Psychiatric disorders                 
Anxiety † 1  8/36 (22.22%)  5/21 (23.81%)  6/37 (16.22%)  2/19 (10.53%)  0/1 (0.00%)  0/2 (0.00%)  17/55 (30.91%)  4/21 (19.05%) 
Depression † 1  5/36 (13.89%)  4/21 (19.05%)  5/37 (13.51%)  4/19 (21.05%)  0/1 (0.00%)  0/2 (0.00%)  8/55 (14.55%)  3/21 (14.29%) 
Insomnia † 1  8/36 (22.22%)  5/21 (23.81%)  12/37 (32.43%)  7/19 (36.84%)  0/1 (0.00%)  0/2 (0.00%)  18/55 (32.73%)  8/21 (38.10%) 
Psychiatric disorders - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  5/55 (9.09%)  0/21 (0.00%) 
Reproductive system and breast disorders                 
Breast pain † 1  8/36 (22.22%)  7/21 (33.33%)  5/37 (13.51%)  3/19 (15.79%)  0/1 (0.00%)  0/2 (0.00%)  5/55 (9.09%)  3/21 (14.29%) 
Vaginal dryness † 1  3/36 (8.33%)  2/21 (9.52%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  5/55 (9.09%)  0/21 (0.00%) 
Reproductive system and breast disorders - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Allergic rhinitis † 1  4/36 (11.11%)  0/21 (0.00%)  0/37 (0.00%)  2/19 (10.53%)  0/1 (0.00%)  0/2 (0.00%)  5/55 (9.09%)  0/21 (0.00%) 
Nasal congestion † 1  2/36 (5.56%)  0/21 (0.00%)  3/37 (8.11%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  0/21 (0.00%) 
Cough † 1  0/36 (0.00%)  2/21 (9.52%)  7/37 (18.92%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  2/21 (9.52%) 
Dyspnea † 1  0/36 (0.00%)  2/21 (9.52%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  5/55 (9.09%)  0/21 (0.00%) 
Sore throat † 1  0/36 (0.00%)  2/21 (9.52%)  0/37 (0.00%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Epistaxis † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  3/19 (15.79%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Skin and subcutaneous tissue disorders                 
Alopecia † 1  5/36 (13.89%)  6/21 (28.57%)  2/37 (5.41%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  6/55 (10.91%)  0/21 (0.00%) 
Dry skin † 1  2/36 (5.56%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  3/55 (5.45%)  0/21 (0.00%) 
Rash acneiform † 1  2/36 (5.56%)  0/21 (0.00%)  0/37 (0.00%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Skin/subcutaneous tissue disorders; Other, specify † 1  3/36 (8.33%)  2/21 (9.52%)  3/37 (8.11%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Hyperhidrosis † 1  0/36 (0.00%)  3/21 (14.29%)  3/37 (8.11%)  2/19 (10.53%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  2/21 (9.52%) 
Pruritus † 1  0/36 (0.00%)  3/21 (14.29%)  3/37 (8.11%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  4/55 (7.27%)  0/21 (0.00%) 
Rash maculo-papular † 1  0/36 (0.00%)  2/21 (9.52%)  4/37 (10.81%)  1/19 (5.26%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  2/21 (9.52%) 
Body odor † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Surgical and medical procedures                 
Surgical and medical procedures - Other, specify † 1  0/36 (0.00%)  0/21 (0.00%)  2/37 (5.41%)  0/19 (0.00%)  0/1 (0.00%)  0/2 (0.00%)  0/55 (0.00%)  0/21 (0.00%) 
Vascular disorders                 
Hot flashes † 1  21/36 (58.33%)  17/21 (80.95%)  14/37 (37.84%)  10/19 (52.63%)  0/1 (0.00%)  0/2 (0.00%)  37/55 (67.27%)  17/21 (80.95%) 
Hypertension † 1  15/36 (41.67%)  6/21 (28.57%)  13/37 (35.14%)  8/19 (42.11%)  0/1 (0.00%)  0/2 (0.00%)  13/55 (23.64%)  5/21 (23.81%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Otto Metzger
Organization: Dana-Farber Cancer Institute
Phone: 6176323800
EMail: otto_metzger@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Otto Metzger, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02764541    
Other Study ID Numbers: 16-052
First Submitted: May 4, 2016
First Posted: May 6, 2016
Results First Submitted: February 15, 2023
Results First Posted: August 31, 2023
Last Update Posted: March 20, 2024