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Antiandrogen

Palbociclib + Bicalutamide for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Ayca Gucalp, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No prior treatment with bicalutamide

ECOG performance status 0-2

Must not have

Uncontrolled intercurrent illness including known ongoing or active infection, HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Not recovered from adverse events of prior therapy to ≤ NCI CTCAEv4.0 Grade 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an investigational drug can safely and effectively treat a certain type of breast cancer.

Who is the study for?

This trial is for postmenopausal women with AR(+) metastatic breast cancer who haven't been treated with bicalutamide or CDK4/6 inhibitors. Participants must have adequate organ function, not be pregnant, and agree to use contraception. They should have recovered from previous treatments and cannot have active severe illnesses or a history of certain heart conditions.

What is being tested?

The study tests the combination of palbociclib (an investigational drug) and bicalutamide in treating triple negative, AR(+) metastatic breast cancer. It aims to determine the safety and effectiveness of this treatment regimen.

What are the potential side effects?

Possible side effects include fatigue, nausea, blood count changes, potential liver issues, diarrhea, hair loss that doesn't return to normal after prior therapy (alopecia), and other symptoms related to impacting hormone levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never been treated with bicalutamide.

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

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I am postmenopausal or using hormone therapy for menopause.

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I can swallow pills without any issues.

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It's been over 2 weeks since my last cancer treatment and any side effects are mild or gone, except for hair loss.

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I had major surgery over 3 weeks ago and have fully recovered.

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My cancer is hormone receptor positive.

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My cancer has spread to other parts of my body.

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I can provide a tissue sample for research.

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I do not have any other cancer that needs treatment besides breast cancer.

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I am 18 years old or older.

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I am a woman diagnosed with invasive breast cancer.

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My cancer is not HER2 positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe illnesses or conditions that would interfere with the study.

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I have recovered from previous cancer treatment side effects.

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I have received hormone therapy for cancer.

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I have or my family has a history of long-QT syndrome.

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I am not taking medication that strongly affects certain liver enzymes.

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I have been treated with a CDK4/6 inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

progression free survival (phase II)

recommended phase II dose (RP2D) (phase I)

Secondary study objectives

Clinical benefit rate (CBR)

Objective response rate (CR+PR)

Progression-free survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Palbociclib in Combination with BicalutamideExperimental Treatment2 Interventions

This is a non-randomized, open-label, phase I/II trial for patients with AR(+) MBC . There will be a dose finding phase I portion of the study to establish the recommended phase II dose (R2PD). This will be followed by a phase II where efficacy is evaluated. Patients with AR(+)ER(-) breast cancer treated on the phase I at the recommended phase II dose will be counted towards the primary endpoint analysis for the phase II study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bicalutamide

2003

Completed Phase 3

~6210

Palbociclib

2017

Completed Phase 3

~3790