Immunotherapy + Hormone Therapy for Advanced Breast Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byJoanne Mortimer

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well pembrolizumab works when given together with endocrine therapy and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Estrogen can cause the growth of breast cancer cells. Fulvestrant blocks the use of estrogen by the tumor cells. Letrozole lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab, palbociclib, and letrozole or fulvestrant may be an effective treatment for patients with stage IV estrogen receptor positive breast cancer.

Research Team

Joanne Mortimer

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for postmenopausal women with newly diagnosed stage IV estrogen receptor positive breast cancer. Participants must be over 18, willing to provide consent and tissue samples, have a life expectancy of at least 3 months, and meet specific health criteria. They cannot join if they have brain metastases, received certain vaccines or treatments recently, are pregnant/breastfeeding, or have serious health issues like active autoimmune diseases.

Inclusion Criteria

I am not pregnant and agree to use birth control.

My breast cancer is stage IV, ER positive, HER2 negative, and confirmed by tests.

I can take care of myself and am up and about more than half of the day.

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Exclusion Criteria

I don't have any health issues that could affect the trial's results.

I have a history of HIV or active hepatitis B/C.

I have not received a live vaccine in the last 30 days.

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Treatment Details

Interventions

Fulvestrant (Hormone Therapy)
Letrozole (Hormone Therapy)
Palbociclib (Cyclin-Dependent Kinase Inhibitor)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe study tests pembrolizumab (an immunotherapy drug) combined with endocrine therapy (fulvestrant or letrozole) and palbociclib against metastatic breast cancer. It aims to see if this combination can help the immune system fight cancer and stop tumor growth by blocking hormones and enzymes that cancer cells need.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohorts 1 and 2 (letrozole, palbociclib, pembrolizumab)Experimental Treatment4 Interventions

Patients receive letrozole PO QD on days 1-28 and palbociclib PO QD for 3 weeks. Cycles with letrozole and palbociclib repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group II: Cohort 3 (letrozole, palbociclib, fulvestrant, pembrolizumab)Experimental Treatment5 Interventions

Patients receive either letrozole PO QD on days -28 to -1 and days 1-28, or fulvestrant on days -28, -14, and day 1 of subsequent cycles. Patients also receive palbociclib PO QD for 3 weeks. Cycles with palbociclib, and letrozole or fulvestrant repeat every 28 days in the absence disease progression or unacceptable toxicity. Patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles with pembrolizumab repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Fulvestrant is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Faslodex for: