Palbociclib + Hormone Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+446 other locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Alliance for Clinical Trials in Oncology

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

Eligibility Criteria

This trial is for patients aged 70+ with estrogen receptor positive, HER2 negative metastatic breast cancer. They must have adequate organ function, no active infections or recent malignancies (except certain skin cancers), and be able to understand English or Spanish. Prior treatment with CDK inhibitors disqualifies them, as does untreated brain metastases or known lung disease.

Inclusion Criteria

I have no active cancer other than non-melanoma skin cancer or cervical carcinoma in situ, or I have been free of any other cancer for 3 years.

Your body has enough infection-fighting white blood cells.

My breast cancer is estrogen or progesterone positive and HER2 negative.

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Treatment Details

Interventions

Fulvestrant (Estrogen Receptor Antagonist)
Letrozole (Aromatase Inhibitor)
Palbociclib (CDK4/6 Inhibitor)

Trial OverviewThe study tests the effectiveness of palbociclib combined with letrozole or fulvestrant in older adults with advanced breast cancer. It examines how well these drugs stop tumor growth by blocking enzymes needed for cell division and spread, considering factors beyond age that may affect drug toxicity.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (palbociclib, letrozole or fulvestrant)Experimental Treatment5 Interventions

Patients receive palbociclib PO QD on days 1-21. Patients also receive letrozole PO QD on days 1-28 or fulvestrant IM on days 1 and 15 of course 1 and on day 1 of subsequent courses per MD discretion. Courses repeat every 28 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: