46 Participants Needed

Palbociclib + Bicalutamide for Breast Cancer

Recruiting at 5 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 1 & 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you must stop all current medications, but you should avoid medications that strongly affect CYP3A4, as they can interact with palbociclib. It's best to discuss your current medications with the trial team to see if any changes are needed.

What data supports the effectiveness of the drug combination Palbociclib and Bicalutamide for breast cancer?

Palbociclib has been shown to be effective in treating hormone receptor-positive, HER2-negative advanced breast cancer when combined with other drugs like fulvestrant, significantly improving progression-free survival. This suggests that Palbociclib may be beneficial in similar drug combinations for breast cancer treatment.12345

Is the combination of Palbociclib and Bicalutamide safe for humans?

Palbociclib has been studied extensively and is generally considered safe for treating certain types of breast cancer in both men and women, with no new safety concerns identified in recent studies. However, specific safety data for the combination of Palbociclib and Bicalutamide is not available in the provided research.26789

What makes the drug Palbociclib unique for breast cancer treatment?

Palbociclib is unique because it is a cyclin-dependent kinase 4 and 6 inhibitor, which specifically targets hormone receptor-positive breast cancer, and is often used in combination with endocrine therapy to enhance its effectiveness.310111213

What is the purpose of this trial?

The purpose of this study is to test the safety and effectiveness of the investigational drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor positive breast cancer.

Research Team

Ayca Gucalp, MD - MSK Breast Medical ...

Ayca Gucalp, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My tumor tests positive for androgen receptors.
My brain cancer has not worsened in the last 3 months.
I have never been treated with bicalutamide.
See 16 more

Exclusion Criteria

You are currently taking any experimental cancer drugs.
You have had allergic reactions to drugs similar to palbociclib.
Pregnant women and women who are breast-feeding
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Phase I Treatment

Dose finding lead-in to establish the recommended phase II doses for the combination of palbociclib and bicalutamide using a standard 3+3 design

Up to 1 year
Every 2 weeks during Cycle #1 and 2, then every 4 weeks

Phase II Treatment

Efficacy evaluation of palbociclib and bicalutamide at the recommended phase II dose

6 months
Radiographic response evaluation every 8 weeks for cycles 1-6, then every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Bicalutamide
  • Palbociclib
Trial Overview 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.
Participant Groups
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.

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

🇪🇺
Approved in European Union as Casodex for:
  • Metastatic prostate cancer
  • Locally advanced prostate cancer
🇺🇸
Approved in United States as Casodex for:
  • Metastatic prostate cancer
🇯🇵
Approved in Japan as Casodex for:
  • Metastatic prostate cancer
  • Locally advanced prostate cancer
🇨🇦
Approved in Canada as Casodex for:
  • Metastatic prostate cancer
  • Locally advanced prostate cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Findings from Research

Palbociclib, when combined with fulvestrant, significantly improves progression-free survival in women with hormone receptor-positive, HER2-negative advanced breast cancer, showing a median PFS of 9.5 months compared to 4.6 months with placebo, based on a study of 521 women.
The safety profile of palbociclib includes common adverse reactions such as neutropenia and infections, which were observed in over 20% of patients, confirming its known side effects.
FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer.Walker, AJ., Wedam, S., Amiri-Kordestani, L., et al.[2022]
In a study involving 1723 women with HR+/HER2- advanced or metastatic breast cancer, palbociclib combined with aromatase inhibitors or fulvestrant showed low dose-reduction rates (18.9% and 12.3%, respectively), indicating good tolerability.
The treatment demonstrated favorable progression-free rates (PFR) at 12 months, with 88.1% for palbociclib + AI and 79.8% for palbociclib + fulvestrant, along with high survival rates (97.3% and 97.5%, respectively), suggesting its effectiveness in real-world clinical settings.
Real-world treatment of patients with palbociclib for HR+/HER2-advanced/metastatic breast cancer: the Europe IRIS study.Mycock, K., Zhan, L., Hart, K., et al.[2022]
Oral palbociclib is an effective treatment for HR-positive, HER2-negative advanced or metastatic breast cancer, significantly prolonging progression-free survival when used with letrozole or fulvestrant in clinical trials involving postmenopausal women.
The most common side effect was neutropenia, which was manageable and rarely led to serious complications, indicating that palbociclib can be safely administered without significantly compromising its efficacy.
Palbociclib: A Review in HR-Positive, HER2-Negative, Advanced or Metastatic Breast Cancer.Kim, ES., Scott, LJ.[2022]

References

FDA Approval of Palbociclib in Combination with Fulvestrant for the Treatment of Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer. [2022]
Real-world treatment of patients with palbociclib for HR+/HER2-advanced/metastatic breast cancer: the Europe IRIS study. [2022]
Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving Palbociclib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer in Argentina: The IRIS Study. [2020]
Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. [2022]
Palbociclib: A Review in HR-Positive, HER2-Negative, Advanced or Metastatic Breast Cancer. [2022]
FDA Approval Summary: Palbociclib for Male Patients with Metastatic Breast Cancer. [2021]
Real-World Data of Palbociclib in Combination With Endocrine Therapy for the Treatment of Metastatic Breast Cancer in Men. [2022]
A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance® Patient Program. [2023]
Palbociclib and endocrine therapy in heavily pretreated hormone receptor-positive HER2-negative advanced breast cancer: the UK Compassionate Access Programme experience. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A Phase II Single-arm Study of Palbociclib in Patients With HER2-positive Breast Cancer With Brain Metastases and Analysis of ctDNA in Patients With Active Brain Metastases. [2023]
Real life efficacy of palbociclib and endocrine therapy in HR positive, HER2 negative advanced breast cancer. [2023]
Impact of Dose Reduction on Efficacy: Implications of Exposure-Response Analysis of Palbociclib. [2021]
Prognostic role of tumor subtype and germline BRCA mutation in advanced breast cancer patients treated with palbociclib plus endocrine therapy. [2022]
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