The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Palbociclib With Everolimus + Exemestane In BC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02871791
Recruitment Status : Completed
First Posted : August 18, 2016
Results First Posted : August 29, 2022
Last Update Posted : August 29, 2022
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Sara Tolaney, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Hormone Receptor (HR)-Positive Breast Cancer
Interventions Drug: Palbociclib
Drug: Everolimus
Drug: Exemestane
Enrollment 41
Recruitment Details September 12, 2016 to June 26, 2019
Pre-assignment Details  
Arm/Group Title Dose 0: Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg Dose 1: Palbociclib 125mg, Everolimus 5mg, Exemestane 25mg
Hide Arm/Group Description
  • Palbociclib 100mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
  • Palbociclib 125mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
Period Title: Phase 1b
Started 6 3
Completed 0 0
Not Completed 6 3
Reason Not Completed
Death             0             1
progressive disease             6             2
Period Title: Phase 2
Started 32 0
Completed 29 0
Not Completed 3 0
Reason Not Completed
Death             1             0
Lost to Follow-up             2             0
Arm/Group Title [Phase 2a] Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 0: Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 1: Palbociclib 125mg, Everolimus 5mg, Exemestane 25mg Total
Hide Arm/Group Description
  • Palbociclib 100 mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
  • Palbociclib 100 mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
  • Palbociclib 125 mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
 Total of all reporting groups
Overall Number of Baseline Participants 32 6 3 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants 6 participants 3 participants 41 participants
55.5
(36 to 73)
52
(40 to 67)
68
(48 to 75)
55.5
(36 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 6 participants 3 participants 41 participants
Female
32
 100.0%
6
 100.0%
3
 100.0%
41
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 32 participants 6 participants 3 participants 41 participants
White
29
  90.6%
6
 100.0%
3
 100.0%
38
  92.7%
Black
2
   6.3%
0
   0.0%
0
   0.0%
2
   4.9%
Asian
1
   3.1%
0
   0.0%
0
   0.0%
1
   2.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 6 participants 3 participants 41 participants
32 6 3 0
1.Primary Outcome
Title Clinical Benefit Rate (CBR) [Phase 2a]
Hide Description CBR is defined as the proportion of participants achieving complete response, partial response or stable disease for more than 6 months (CR+PR+SD ≥ 24 weeks) taking as reference the smallest measurements recorded since the treatment started, including the baseline measurements.
Time Frame Disease evaluations were performed every 8 weeks (within 24 weeks of initiation of study treatment) or every 12 weeks (greater than 24 weeks of initiation of study treatment). Treatment duration has a median of 111 days and maximum of 681 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib, Everolimus, Exemestane
Hide Arm/Group Description:
  • Palbociclib 100mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
6
  18.8%
2.Secondary Outcome
Title Overall Response Rate (ORR) [Phase 2a]
Hide Description The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment.
Time Frame Disease evaluations were performed every 8 weeks (within 24 weeks of initiation of study treatment) or every 12 weeks (greater than 24 weeks of initiation of study treatment). Treatment duration has a median of 111 days and maximum of 681 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib, Everolimus, Exemestane
Hide Arm/Group Description:
  • Palbociclib 100mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Disease Control Rate (DCR) [Phase 2a]
Hide Description The DCR defined as the proportion of patient that has CR+PR+SD>=12 weeks. Response will be assessed among participants eligible for the phase IIa part of the study who received at least one dose of the study drugs at the MTD/RP2D and have measurable disease at screening.
Time Frame Disease evaluations were performed every 8 weeks (within 24 weeks of initiation of study treatment) or every 12 weeks (greater than 24 weeks of initiation of study treatment). Treatment duration has a median of 111 days and maximum of 681 days.
Hide Outcome Measure Data
Hide Analysis Population Description
2 patients lost follow-up from the study after treatment begins
Arm/Group Title Palbociclib, Everolimus, Exemestane
Hide Arm/Group Description:
  • Palbociclib 100mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
Overall Number of Participants Analyzed 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of patients
0.563
(0.393 to 0.719)
4.Secondary Outcome
Title Duration of Response (DOR) [Phase 2a]
Hide Description Response will be assessed among participants eligible for the phase IIa part of the study who received at least one dose of the study drugs at the MTD/RP2D and have measurable disease at screening. DOR defined based on the duration of stable disease.
Time Frame Disease evaluations were performed every 8 weeks (within 24 weeks of initiation of study treatment) or every 12 weeks (greater than 24 weeks of initiation of study treatment). Treatment duration has a median of 111 days and maximum of 681 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib, Everolimus, Exemestane
Hide Arm/Group Description:
  • Palbociclib 100mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: months
4.24
(3.68 to 7.82)
5.Secondary Outcome
Title Median Progression Free Survival (PFS) [Phase 2a]
Hide Description Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.
Time Frame Disease is evaluated and followed-up every 8 weeks, with median of 20.04 months and maximum of 35.64 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Palbociclib, Everolimus, Exemestane
Hide Arm/Group Description:
  • Palbociclib 100mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: months
3.8
(2 to 5.4)
Time Frame Adverse events are evaluated every 8 days each cycle on treatment, and at the end of the therapy. Treatment duration has a median of 111 days and maximum of 681 days.
Adverse Event Reporting Description Serious adverse events (AEs) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv4. All remaining events regardless of treatment attribution were classified as Other AEs. Maximum grade toxicity by type for a patient over time was calculated. No further data is available to specify classification of other beyond the general term.
 
Arm/Group Title [Phase 2a] Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 0: Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 1: Palbociclib 125mg, Everolimus 5mg, Exemestane 25mg
Hide Arm/Group Description
  • Palbociclib 100mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
  • Palbociclib 100 mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
  • Palbociclib 125 mg will be administered orally, once daily for 21 consecutive days followed by a 7-day rest (28-day cycle)
  • Everolimus 5 mg will be administered orally, once daily on a 28 day schedule
  • Exemestane 25 mg will be administered orally, once daily on a 28 day schedule
All-Cause Mortality
[Phase 2a] Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 0: Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 1: Palbociclib 125mg, Everolimus 5mg, Exemestane 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/32 (50.00%)   0/6 (0.00%)   1/3 (33.33%) 
Hide Serious Adverse Events
[Phase 2a] Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 0: Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 1: Palbociclib 125mg, Everolimus 5mg, Exemestane 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/32 (87.50%)   5/6 (83.33%)   3/3 (100.00%) 
Blood and lymphatic system disorders       
Anemia † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Febrile neutropenia † 1  0/32 (0.00%)  0/6 (0.00%)  1/3 (33.33%) 
Gastrointestinal disorders       
Diarrhea † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Gastric ulcer † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Mucositis oral † 1  5/32 (15.63%)  0/6 (0.00%)  0/3 (0.00%) 
Investigations       
Alanine aminotransferase increased † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Alkaline phosphatase increased † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Aspartate aminotransferase increased † 1  4/32 (12.50%)  0/6 (0.00%)  0/3 (0.00%) 
Neutrophil count decreased † 1  25/32 (78.13%)  4/6 (66.67%)  3/3 (100.00%) 
Platelet count decreased † 1  3/32 (9.38%)  0/6 (0.00%)  2/3 (66.67%) 
White blood cell decreased † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders       
Dehydration † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Hyperglycemia † 1  0/32 (0.00%)  1/6 (16.67%)  0/3 (0.00%) 
Hypokalemia † 1  0/32 (0.00%)  1/6 (16.67%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (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 0%
[Phase 2a] Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 0: Palbociclib 100mg, Everolimus 5mg, Exemestane 25mg [Phase 1b]Dose 1: Palbociclib 125mg, Everolimus 5mg, Exemestane 25mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/32 (100.00%)   6/6 (100.00%)   3/3 (100.00%) 
Blood and lymphatic system disorders       
Anemia † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Cardiac disorders       
Sinus tachycardia † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Endocrine disorders       
Endocrine disorders - Other, specify † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders       
Abdominal pain † 1  4/32 (12.50%)  0/6 (0.00%)  0/3 (0.00%) 
Constipation † 1  3/32 (9.38%)  0/6 (0.00%)  1/3 (33.33%) 
Diarrhea † 1  10/32 (31.25%)  0/6 (0.00%)  0/3 (0.00%) 
Dry mouth † 1  4/32 (12.50%)  0/6 (0.00%)  0/3 (0.00%) 
Dyspepsia † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Enterocolitis † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Flatulence † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Gastrointestinal disorders - Other, specify † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Hemorrhoids † 1  0/32 (0.00%)  0/6 (0.00%)  1/3 (33.33%) 
Jejunal hemorrhage † 1  0/32 (0.00%)  1/6 (16.67%)  0/3 (0.00%) 
Lip pain † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Mucositis oral † 1  31/32 (96.88%)  6/6 (100.00%)  3/3 (100.00%) 
Nausea † 1  11/32 (34.38%)  1/6 (16.67%)  1/3 (33.33%) 
Oral pain † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Stomach pain † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Toothache † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Vomiting † 1  5/32 (15.63%)  0/6 (0.00%)  0/3 (0.00%) 
General disorders       
Chills † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Edema limbs † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Fatigue † 1  21/32 (65.63%)  3/6 (50.00%)  2/3 (66.67%) 
Fever † 1  3/32 (9.38%)  0/6 (0.00%)  0/3 (0.00%) 
Gait disturbance † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Pain † 1  3/32 (9.38%)  0/6 (0.00%)  1/3 (33.33%) 
Immune system disorders       
Allergic reaction † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Infections and infestations       
Lung infection † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Sinusitis † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Tooth infection † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Upper respiratory infection † 1  4/32 (12.50%)  0/6 (0.00%)  0/3 (0.00%) 
Urinary tract infection † 1  1/32 (3.13%)  3/6 (50.00%)  0/3 (0.00%) 
Investigations       
Alanine aminotransferase increased † 1  7/32 (21.88%)  1/6 (16.67%)  0/3 (0.00%) 
Alkaline phosphatase increased † 1  3/32 (9.38%)  1/6 (16.67%)  0/3 (0.00%) 
Aspartate aminotransferase increased † 1  5/32 (15.63%)  1/6 (16.67%)  0/3 (0.00%) 
Blood bilirubin increased † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Creatinine increased † 1  0/32 (0.00%)  1/6 (16.67%)  2/3 (66.67%) 
Investigations - Other, specify † 1  0/32 (0.00%)  3/6 (50.00%)  0/3 (0.00%) 
Lymphocyte count decreased † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Neutrophil count decreased † 1  28/32 (87.50%)  5/6 (83.33%)  3/3 (100.00%) 
Platelet count decreased † 1  17/32 (53.13%)  2/6 (33.33%)  3/3 (100.00%) 
Weight loss † 1  2/32 (6.25%)  1/6 (16.67%)  0/3 (0.00%) 
White blood cell decreased † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Metabolism and nutrition disorders       
Anorexia † 1  8/32 (25.00%)  0/6 (0.00%)  0/3 (0.00%) 
Dehydration † 1  4/32 (12.50%)  0/6 (0.00%)  0/3 (0.00%) 
Hyperglycemia † 1  3/32 (9.38%)  2/6 (33.33%)  1/3 (33.33%) 
Hypoglycemia † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Hypokalemia † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Hyponatremia † 1  3/32 (9.38%)  0/6 (0.00%)  0/3 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  3/32 (9.38%)  0/6 (0.00%)  0/3 (0.00%) 
Back pain † 1  2/32 (6.25%)  1/6 (16.67%)  0/3 (0.00%) 
Neck pain † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Nervous system disorders       
Brachial plexopathy † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Dysgeusia † 1  7/32 (21.88%)  0/6 (0.00%)  1/3 (33.33%) 
Headache † 1  8/32 (25.00%)  2/6 (33.33%)  1/3 (33.33%) 
Peripheral sensory neuropathy † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Psychiatric disorders       
Anxiety † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Depression † 1  0/32 (0.00%)  2/6 (33.33%)  0/3 (0.00%) 
Insomnia † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Renal and urinary disorders       
Urinary frequency † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Urinary incontinence † 1  0/32 (0.00%)  1/6 (16.67%)  0/3 (0.00%) 
Reproductive system and breast disorders       
Breast pain † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Vaginal dryness † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis † 1  3/32 (9.38%)  0/6 (0.00%)  0/3 (0.00%) 
Cough † 1  4/32 (12.50%)  1/6 (16.67%)  0/3 (0.00%) 
Dyspnea † 1  6/32 (18.75%)  2/6 (33.33%)  1/3 (33.33%) 
Epistaxis † 1  6/32 (18.75%)  1/6 (16.67%)  2/3 (66.67%) 
Hiccups † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Pleural effusion † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
Pneumonitis † 1  10/32 (31.25%)  0/6 (0.00%)  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders - Other, specify † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Tracheal fistula † 1  3/32 (9.38%)  0/6 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia † 1  0/32 (0.00%)  2/6 (33.33%)  0/3 (0.00%) 
Dry skin † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Pruritus † 1  3/32 (9.38%)  0/6 (0.00%)  0/3 (0.00%) 
Rash acneiform † 1  10/32 (31.25%)  0/6 (0.00%)  1/3 (33.33%) 
Rash maculo-papular † 1  2/32 (6.25%)  0/6 (0.00%)  0/3 (0.00%) 
Vascular disorders       
Hot flashes † 1  1/32 (3.13%)  1/6 (16.67%)  0/3 (0.00%) 
Hypertension † 1  1/32 (3.13%)  0/6 (0.00%)  0/3 (0.00%) 
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: Sara Tolaney, MD MPH
Organization: Dana-Farber Cancer Institute
Phone: 617-632-5743
EMail: Sara_Tolaney@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Sara Tolaney, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02871791    
Other Study ID Numbers: 16-177
First Submitted: June 29, 2016
First Posted: August 18, 2016
Results First Submitted: January 26, 2022
Results First Posted: August 29, 2022
Last Update Posted: August 29, 2022