Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Apr 11, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called palbociclib, combined with another treatment called fulvestrant, for women with metastatic breast cancer who have already been treated with palbociclib and an aromatase inhibitor. The goal is to see if continuing palbociclib with fulvestrant can help manage the cancer after it has worsened despite previous treatments.

To be eligible for this trial, participants should be women, either premenopausal or postmenopausal, with advanced breast cancer that cannot be treated with surgery or radiation. They must have a specific type of tumor that is hormone receptor-positive and HER2-negative, and they should have progressed after at least six months of treatment with palbociclib and an aromatase inhibitor. Participants can expect to receive the combination treatment and will be monitored closely throughout the study. It's important to note that certain health conditions or recent treatments may exclude potential participants, so a thorough review of medical history will be done before enrollment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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