Triple Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDavid B. Page, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Providence Health & Services

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The goal of this protocol is to evaluate the safety and efficacy of an alternative systemic combination approach that omits or delays the use of chemotherapy in metastatic disease, while improving efficacy and durability of response. The approach combines two potentially effective and previously studied strategies: androgen receptor blockade and immune checkpoint therapy.

Eligibility Criteria

This trial is for women over 18 with HER2-negative breast cancer that's advanced and can't be removed by surgery or has spread (metastatic). They should have had no more than one chemotherapy treatment in the non-curative setting, must not be breastfeeding, agree to birth control measures, and have good blood and liver function. Men, pregnant women, those with certain medical conditions or a history of other cancers within the last three years are excluded.

Inclusion Criteria

I am fully active or can carry out light work.

My breast cancer cannot be removed by surgery and is not HER2 positive.

I've had only one chemotherapy treatment for my cancer that wasn't meant to cure it.

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Exclusion Criteria

I have an autoimmune disease but it's under control or is one of the exceptions listed.

I have lung disease that could affect my treatment's safety monitoring.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness/social situations that would limit obtaining informed consent or compliance with study requirements

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Treatment Details

Interventions

Bicalutamide (Androgen Receptor Blockade)
Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe study tests combining Nivolumab and Ipilimumab (immune checkpoint inhibitors) with Bicalutamide (androgen receptor blocker) as an alternative to chemotherapy for metastatic breast cancer. It aims to see if this combination improves response without using chemo initially or delaying its need.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Nivolumab, Ipilimumab, and bicalutamideExperimental Treatment3 Interventions

Participants will receive nivolumab plus ipilimumab combination therapy. Participants should receive nivolumab at a dose of 240 milligrams (mg) fixed dose as a 30-minute intravenous (IV) infusion prepared in 50 milliliter (ml) normal saline (NS) every 2 weeks until progression. Participants should receive ipilimumab at a dose of 1 mg/kilogram as a 30-minute IV infusion prepared in 50 ml NS every 6 weeks. All subjects will take bicalutamide 150mg (3 x 50mg tablets) daily.

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

🇪🇺 Approved in European Union as Casodex for: