40 Participants Needed

Palbociclib for Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use drugs or foods that strongly affect CYP3A4, an enzyme that processes many medications. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Palbociclib (Ibrance) for cancer?

Palbociclib, when used with other treatments like letrozole or fulvestrant, has been shown to significantly extend the time patients live without their cancer getting worse in cases of advanced breast cancer. It is particularly effective for hormone receptor-positive, HER2-negative breast cancer, and maintains patients' quality of life while doubling the effectiveness of other treatments.12345

What makes the drug Palbociclib unique for cancer treatment?

Palbociclib is unique because it is an oral drug that specifically targets and inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), which are proteins that help cancer cells grow. This makes it different from other treatments as it can be combined with hormone therapies like letrozole or fulvestrant to enhance their effectiveness in treating certain types of breast cancer.12345

What is the purpose of this trial?

This trial tests palbociclib, a medication taken by mouth, in patients with advanced cancers that have specific genetic changes. It works by blocking proteins needed for cancer cell growth. Researchers hope it will shrink the cancer or stop it from growing.

Research Team

AS

Amy S Clark

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for patients with cancers that have specific genetic changes called CCND1, 2, or 3 amplification. They must not have breast cancer, mantle cell lymphoma or myeloma and should not be on certain drugs affecting heart rhythm. Prior treatment with CDK4/6 inhibitors disqualifies them.

Inclusion Criteria

My recent ECG showed no significant heart issues.
Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
My cancer has a specific genetic change related to CCND1, 2, or 3.

Exclusion Criteria

I do not have heart issues related to the left ventricle.
I do not have breast cancer, mantle cell lymphoma, or myeloma.
I am not taking any strong medications or eating foods that affect certain liver enzymes.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive palbociclib orally once daily on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Up to 3 years
Every 2 cycles for the first 26 cycles, then every 3 cycles thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months if less than 2 years from study entry, and then every 6 months for year 3 from study entry.

Up to 3 years
Every 3 months for the first 2 years, then every 6 months for year 3

Treatment Details

Interventions

  • Palbociclib
Trial Overview The trial tests Palbociclib's effectiveness in stopping the growth of cancers with CCND1, 2, or 3 amplifications by blocking proteins CDK4 and CDK6. It's a phase II study to see if this drug can shrink these types of cancers or halt their progression.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (palbociclib)Experimental Treatment1 Intervention
Patients receive palbociclib PO QD days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity

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

🇺🇸
Approved in United States as Ibrance for:
  • HR-positive, HER2-negative advanced or metastatic breast cancer
🇪🇺
Approved in European Union as Ibrance for:
  • HR-positive, HER2-negative locally advanced or metastatic breast cancer
🇨🇦
Approved in Canada as Ibrance for:
  • HR-positive, HER2-negative advanced or metastatic breast cancer
🇯🇵
Approved in Japan as Ibrance for:
  • HR-positive, HER2-negative advanced or recurrent breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 191 patients with metastatic breast cancer receiving palbociclib, the median progression-free survival was 22.8 months for first-line treatment, indicating significant efficacy of the drug in delaying disease progression.
While 47% of patients experienced severe neutropenia, the overall survival rate at 24 months was 74.2% for first-line treatment, suggesting that palbociclib is effective but requires monitoring for potential adverse effects.
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.Palmieri, C., Musson, A., Harper-Wynne, C., et al.[2023]
Palbociclib is a selective inhibitor of CDK4 and CDK6, which are crucial for cell cycle regulation, and has been approved in the US for use with letrozole as a first-line treatment for advanced breast cancer in postmenopausal women.
Ongoing clinical trials are exploring palbociclib's efficacy in various cancer types, including non-small cell lung cancer and other solid tumors, indicating its potential as a versatile treatment option in oncology.
Palbociclib: first global approval.Dhillon, S.[2018]
Palbociclib is the first CDK4/6 inhibitor approved for treating estrogen receptor-positive, HER2-negative metastatic breast cancer, and it works by selectively inhibiting CDK4 and CDK6, enhancing the effects of anti-estrogens like letrozole and fulvestrant.
Clinical trials show that palbociclib significantly doubles the treatment efficacy of letrozole and fulvestrant while maintaining a manageable safety profile, positively impacting patients' quality of life.
The safety and efficacy of palbociclib in the treatment of metastatic breast cancer.Ettl, J., Harbeck, N.[2017]

References

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: first global approval. [2018]
The safety and efficacy of palbociclib in the treatment of metastatic breast cancer. [2017]
Impact of Dose Reduction on Efficacy: Implications of Exposure-Response Analysis of Palbociclib. [2021]
Palbociclib: A Review in HR-Positive, HER2-Negative, Advanced or Metastatic Breast Cancer. [2022]
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