Status:
ACTIVE_NOT_RECRUITING
Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Pfizer
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combinat...
Detailed Description
In this phase II trial, the primary objective is to determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men w...
Eligibility Criteria
Inclusion
- Women may be premenopausal or postmenopausal
- Metastatic or locally advanced breast cancer, not amenable to surgery or radiation with curative intent
- ER-positive and/or PR-positive, HER2-negative tumor
- Prior treatment: progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy; up to one (1) prior line of chemotherapy for advanced disease is allowed in addition to any number of prior lines of endocrine therapy; no prior treatment with fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway in the metastatic setting
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Evaluable or measurable disease
- Disease that is amenable to biopsy
- Adequate hematologic and renal function
- History of central nervous system metastasis is allowed if treated and stable
- Prior radiation therapy is allowed if recovered from toxicity and disease evaluable for response outside of the radiation fields or evidence of post-radiation progression of previously irradiated sites of disease
- Ability to understand and willingness to sign a written informed consent document
Exclusion
- Women who are pregnant or breast-feeding
- Concurrent use of inhibitors or inducers of CYP3A4, or medications which prolong the QTc interval
- Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration; prior radiotherapy to ≥25% of bone marrow are not eligible independent of when it was received
- Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- Any severe cardiac event within 6 months of registration
- Prior hematopoietic stem cell or bone marrow transplantation
- Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or goserelin (if applicable)
- Known or possible hypersensitivity to palbociclib, fulvestrant, goserelin (if applicable) or to any of their excipients
- Known human immunodeficiency virus infection
- Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Key Trial Info
Start Date :
October 25 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02738866
Start Date
October 25 2016
End Date
June 1 2026
Last Update
December 10 2025
Active Locations (5)
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1
Kimmel Cancer Center at Johns Hopkins at Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
2
Anne Arundel Health System Research Institute, Inc.
Annapolis, Maryland, United States, 21401
3
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
4
Allegheny Health Network (AHN) - Allegheny General Hospital ONLY
Pittsburgh, Pennsylvania, United States, 15212