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Antiandrogen

Palbociclib + Bicalutamide for Breast Cancer

Q: What do doctors prescribe Bicalutamide for most often?

<p>Bicalutamide is often used to treat <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>. However, this medication can also be helpful for managing other conditions such as stage d2 prostatic carcinoma and postmenopause malignant neoplasms.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

progression free survival (phase II)

recommended phase II dose (RP2D) (phase I)

Secondary outcome measures

Clinical benefit rate (CBR)

Objective response rate (CR+PR)

Progression-free survival

+1 more

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

~5330

Palbociclib

2017

Completed Phase 3

~3760

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,576 Total Patients Enrolled

203 Trials studying Breast Cancer

81,137 Patients Enrolled for Breast Cancer

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,828 Total Patients Enrolled

111 Trials studying Breast Cancer

36,404 Patients Enrolled for Breast Cancer

Ayca Gucalp, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

23 Total Patients Enrolled

1 Trials studying Breast Cancer

23 Patients Enrolled for Breast Cancer

Media Library

Bicalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02605486 — Phase 1 & 2

Breast Cancer Research Study Groups: Palbociclib in Combination with Bicalutamide

Breast Cancer Clinical Trial 2023: Bicalutamide Highlights & Side Effects. Trial Name: NCT02605486 — Phase 1 & 2

Bicalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02605486 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many distinct locations is this study being conducted?

"Currently, this trial is being conducted at 5 different locations. To make it more convenient for patients, these sites are located in Basking Ridge, Harrison and Middletown as well as other cities."

Answered by AI

What do doctors prescribe Bicalutamide for most often?

"Bicalutamide is often used to treat breast cancer. However, this medication can also be helpful for managing other conditions such as stage d2 prostatic carcinoma and postmenopause malignant neoplasms."

Answered by AI

How many individuals are being evaluated in this clinical trial?

"As of now, this clinical trial has closed recruitment. The study was initially posted on Novemeber 11th, 2015 and was last edited on October 31st, 2022. However, there are presently 2372 trials for breast cancer and 173 Bicalutamide studies that are still admitting patients."

Answered by AI

What are the researchers' goals for this experiment?

"The primary goal of this year-long study is to evaluate progression free survival (phase II). Additionally, the safety and tolerability of the treatment will be assessed, as well as the clinical benefit rate (CBR) and objective response rate (CR+PR)."

Answered by AI

Are there any unfilled vacancies in this clinical trial for new patients?

"Recruitment for this clinical trial has ceased. The study was posted on November 11th, 2015 and updated October 31st, 2022. There are 2372 trials actively recruiting breast cancer patients and 173 Bicalutamide studies presently admitting participants."

Answered by AI

As far as you know, is this the first time a trial like this has been conducted?

"As of now, there are 173 ongoing trials for the drug Bicalutamide in 1535 cities and 58 countries. The first recorded trial began in 2000 and was sponsored by AstraZeneca. This initial study had 600 participants and completed its Phase 3 clinical approval process. Since then, an additional 146 trials have been conducted."

Answered by AI

What other research has been conducted using Bicalutamide?

"There are 173 ongoing trials for Bicalutamide, with the majority being in Phase 3. Out of 10298 total locations, most of the research is based in Melbourne, Victoria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)

2015. "Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02605486.

All > Metastatic Breast Cancer