Study of Pembrolizumab and Fulvestrant for Advanced Hormone Receptor Positive, HER-2 Negative Breast Cancer
Sponsor: Nancy Chan, MD
ClinicalTrials ID:NCT03393845
This clinical trial is testing a combination of pembrolizumab and fulvestrant to see if it can help control advanced breast cancer that is hormone receptor positive and HER-2 negative. The study aims to evaluate the effectiveness and safety of this treatment in patients who have not responded to previous therapies.
Patient Parameters
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Program Overview
This study is exploring whether combining pembrolizumab, an immunotherapy drug, with fulvestrant, a hormone therapy, can effectively treat advanced breast cancer that is hormone receptor positive and HER-2 negative. The trial will involve 47 patients and will measure how well the treatment works in shrinking tumors and delaying cancer progression.
Description
This is a Phase II clinical trial involving patients with advanced breast cancer that is hormone receptor positive and HER-2 negative. The study will include 47 participants to evaluate how well the combination of pembrolizumab and fulvestrant works in reducing tumor size and delaying cancer progression. Pembrolizumab will be given as an intravenous infusion, while fulvestrant will be administered as an injection. The trial aims to see if adding pembrolizumab can enhance the immune response and improve the durability of the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent and authorization for the release of health information.
- Men and women aged 18 and older can participate. Premenopausal women should undergo ovarian suppression or removal.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have a confirmed diagnosis of metastatic breast cancer.
- Must have received no more than two prior treatments for advanced cancer.
- Cancer must be hormone receptor positive and HER-2 negative.
- Must have measurable disease or evaluable bone lesions.
- Must be willing to provide a tumor tissue sample.
- Must have normal heart function and adequate organ function based on specific tests.
- Must have completed prior chemotherapy or hormonal therapy within specified timeframes.
- Must have recovered from any previous treatment side effects.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.
Exclusion Criteria
- Currently receiving or have recently received an investigational treatment.
- Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
- Have a history of active tuberculosis, HIV, or active hepatitis B or C.
- Have an allergy to pembrolizumab or its components.
- Have received more than two lines of chemotherapy or hormonal therapy.
- Have another progressing cancer or require active treatment for another cancer.
- Have active brain metastases or carcinomatous meningitis.
- Have a history of lung disease requiring steroids or active lung disease.
- Have heart failure or recent heart attack.
- Have an active infection requiring treatment.
- Have any condition that might interfere with the study.
- Have psychiatric or substance abuse disorders affecting participation.
- Are breastfeeding or have received certain vaccines recently.
- Have previously received anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Michigan State University, Breslin Cancer Center | 48910 | Lansing | Michigan |
| University of Nebraska Medical Center | 68198 | Omaha | Nebraska |
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| New York University Clinical Cancer Center | 10016 | New York | New York |
| University of Wisconsin | 53705 | Madison | Wisconsin |
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