A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02384239|
Recruitment Status : Completed
First Posted : March 10, 2015
Last Update Posted : February 5, 2021
Approximately 70 patients with hormone receptor positive (HR+) advanced breast cancer will be enrolled. All patients will receive either fulvestrant (500 mg intramuscular (IM) every 2 weeks x 3 then every four weeks) or tamoxifen (20 mg orally daily by physician choice). Pre-menopausal women must be in chemical menopause.
Arm 1 will receive palbociclib 100 mg qd, days 1-21 every 28 days. Arm 2 will receive palbociclib 125 mg qd, days 1-21 every 28 days. Restaging will be performed every 8 weeks. Therapy will be continued until progressive disease (PD) or unacceptable toxicity.
Patients will be randomly allocated in a 1:1 ratio to take either 100 mg or 125 mg of palbociclib. Randomized treatment assignments will be made by permuted blocks, generated by our collaborating statistician at Dana-Farber Cancer Institute.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Hormone Receptor Positive||Drug: Palbociclib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer Previously Exposed to Inhibitors of the PI3K Pathway: A Phase II Study With Pharmacodynamics Markers|
|Actual Study Start Date :||November 4, 2015|
|Actual Primary Completion Date :||January 31, 2021|
|Actual Study Completion Date :||January 31, 2021|
Experimental: Palbociclib 100mg
Treatment arm palbociclib dose 100mg + fulvestrant or tamoxifen
Other Name: Ibrance
Experimental: Palbociclib 125mg
Treatment arm palbociclib dose 125mg + fulvestrant or tamoxifen
Other Name: Ibrance
- Percentage of participants with Grade 3 or 4 Neutropenia [ Time Frame: Up to 24 months ]Grade 3/4 neutropenia as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.03 in patients with prior exposure to 1-3 lines of chemotherapy for metastatic breast cancer
- Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]PFS defined as the interval from study entry to the first documented evidence of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the longest diameter (SLD) of target lesions, taking as reference the smallest sum SLD recorded since the treatment started and minimum 5 mm increase over the nadir, or the appearance of one or more new lesions. Patients who remain progression-free at the time of analysis will be censored at their last date of follow-up.
- Proportion of participants with demonstrated clinical benefit [ Time Frame: Up to 24 weeks ]Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR) or stable disease (SD). Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
- Proportion of participants with an objective response [ Time Frame: Up to 24 weeks ]Defined as the proportion of patients whose best overall response, according to RECIST, is either complete response (CR), a partial response (PR). Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02384239
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37240|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hope S Rugo, MD||University of California, San Francisco|