Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT03633331 |
Recruitment Status :
Active, not recruiting
First Posted : August 16, 2018
Results First Posted : October 15, 2021
Last Update Posted : October 15, 2021
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Estrogen Receptor-positive Breast Cancer HER2/Neu Negative Stage IV Breast Cancer AJCC v6 and v7 |
Interventions |
Drug: Palbociclib Drug: Letrozole Drug: Fulvestrant Other: Questionnaire Administration Other: Quality-of-Life Assessment |
Enrollment | 93 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Treatment (Palbociclib, Letrozole or Fulvestrant) |
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Arm/Group Description |
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies> > Quality-of-Life Assessment: Ancillary studies |
Period Title: Overall Study | |
Started | 93 |
Completed | 92 |
Not Completed | 1 |
Reason Not Completed | |
Withdrawal by Subject | 1 |
Arm/Group Title | Treatment (Palbociclib, Letrozole or Fulvestrant) | |
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Arm/Group Description |
Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Palbociclib: Given PO Letrozole: Given PO Fulvestrant: Given IM Questionnaire Administration: Ancillary studies> > Quality-of-Life Assessment: Ancillary studies |
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Overall Number of Baseline Participants | 93 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 93 participants | |
74
(70 to 87)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 93 participants | |
Female |
92 98.9%
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Male |
1 1.1%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 93 participants | |
Hispanic or Latino |
3 3.2%
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Not Hispanic or Latino |
88 94.6%
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Unknown or Not Reported |
2 2.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 93 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
1 1.1%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
4 4.3%
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White |
85 91.4%
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More than one race |
0 0.0%
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Unknown or Not Reported |
3 3.2%
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Name/Title: | Mina S. Sedrak MD, MS |
Organization: | City of Hope Comprehensive Cancer Center |
Phone: | 626-218-4173 |
EMail: | msedrak@coh.org |
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT03633331 |
Other Study ID Numbers: |
A171601 NCI-2017-01596 ( Registry Identifier: NCI Clinical Trial Reporting Program ) |
First Submitted: | August 7, 2018 |
First Posted: | August 16, 2018 |
Results First Submitted: | September 17, 2021 |
Results First Posted: | October 15, 2021 |
Last Update Posted: | October 15, 2021 |