Continued Palbociclib Treatment for Breast Cancer

Not currently recruiting at 27 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must be taking: Palbociclib

Disqualifiers: Medical reasons, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of continuing treatment with palbociclib (also known as Ibrance, a cancer drug) and other medicines like cetuximab, letrozole, and fulvestrant for breast cancer. The goal is to determine if these treatments remain safe over time. Individuals who have already benefited from palbociclib in a previous study and adhere to study guidelines might be suitable candidates. Participants will continue their treatment while researchers monitor for any safety concerns. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants will continue the same treatment as in the parent study, it's likely you can keep taking your current medications unless advised otherwise by the study doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatment combinations in this study have undergone safety testing in earlier studies.

For the Palbociclib and Cetuximab combination, studies indicate that these medicines are generally well-tolerated. Some patients experienced a reduction in their cancer, and the safety data suggests that any side effects can be managed with standard medical care.

Regarding Palbociclib with Letrozole, the safety and side effects were mostly manageable with dose adjustments or medical help. This combination has been used as a first treatment option, demonstrating its safety for many patients.

For the Palbociclib and Fulvestrant combination, research supports that this treatment is generally safe and well-tolerated in patients with certain types of breast cancer. The common side effects align with those expected from these drugs.

Palbociclib already has FDA approval for breast cancer, which enhances its known safety profile. Participants in this clinical trial will continue to receive these treatments, aiding researchers in confirming their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments involving Palbociclib because they offer a novel approach to managing breast cancer by targeting the cell cycle, specifically cyclin-dependent kinases 4 and 6 (CDK4/6). Unlike traditional chemotherapy, which can affect both cancerous and healthy cells, Palbociclib, when combined with Cetuximab, Letrozole, or Fulvestrant, aims to selectively halt cancer cell division with potentially fewer side effects. This targeted action can lead to improved efficacy and tolerability, providing a promising alternative for patients with advanced breast cancer who may not respond well to standard hormone therapies or chemotherapy. By combining Palbociclib with other agents, researchers hope to enhance the drug's effectiveness and extend the benefits to a broader group of patients.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Studies have shown that Palbociclib, one of the treatments in this trial, effectively treats breast cancer when combined with other therapies. Participants may receive Palbociclib with Letrozole, which has increased the time patients live without their cancer worsening. Research found that patients lived longer on average with this combination. Another group will receive Palbociclib with Fulvestrant, which also showed good results, with patients living 6.9 months longer without disease progression. While Cetuximab alone has had mixed results, participants may receive it with Palbociclib, a combination that has shown promise in reducing cancer cell activity in some studies. Overall, combinations with Palbociclib have effectively slowed breast cancer progression in multiple studies. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people who are already taking part in a Pfizer palbociclib study and seeing benefits. They must be able to follow the study's rules, including reproductive guidelines, attend all visits, and stick to treatment plans. Participants need to sign a consent form agreeing to these terms.

Inclusion Criteria

I can sign and follow the study's consent form and rules.

Any participant who is receiving study treatment and deriving clinical benefit as determined by the investigator in a Pfizer-sponsored palbociclib Parent Study

Participants must agree to follow the reproductive criteria

Exclusion Criteria

Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue to receive treatment as they were in the parent study to provide continued access to treatment and monitor safety

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cetuximab
• Fulvestrant
• Letrozole
• Palbociclib

Trial Overview Participants will continue receiving Letrozole, Palbociclib, Cetuximab, or Fulvestrant as they did in the previous palbociclib studies. The focus is on monitoring safety and understanding how well these medicines work over an extended period after the initial study has ended.

How Is the Trial Designed?

Group I: Arm 4 Experimental Treatment 2 Interventions

Palbociclib plus Letrozole

Group II: Arm 3 Experimental Treatment 2 Interventions

Palbociclib plus Fulvestrant

Group III: Arm 2 Experimental Treatment 2 Interventions

Palbociclib plus Cetuximab

Group IV: Arm 1 Experimental Treatment 1 Intervention

Cetuximab

Cetuximab is already approved in United States, European Union for the following indications:

Approved in United States as Erbitux for:

• Locally or regionally advanced squamous cell carcinoma of the head and neck
• Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
• K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
• BRAF V600E mutation-positive metastatic colorectal cancer

Approved in European Union as Erbitux for:

• Squamous cell carcinoma of the head and neck
• K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer

Who Is Running the Clinical Trial?

Pfizer

Lead 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

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Palbociclib, in combination with letrozole, is FDA-approved for treating postmenopausal women with hormone-receptor-positive, HER2-negative advanced breast cancer, showing its efficacy as an initial therapy.

The combination of palbociclib with fulvestrant has been found to provide better outcomes than fulvestrant alone for patients who have previously progressed on endocrine therapy, highlighting its potential in advanced treatment scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palbociclib: a first-in-class CDK4/CDK6 inhibitor for the treatment of hormone-receptor positive advanced breast cancer. Lu, J.[2022]

In the PALOMA-2 trial involving 666 postmenopausal women with ER+/HER2- advanced breast cancer, the combination of palbociclib and letrozole significantly improved progression-free survival compared to letrozole alone, with a hazard ratio of 0.58.

Neutropenia was the most common adverse event associated with palbociclib, occurring in 95.3% of patients, but it was mostly manageable through dose modifications and did not compromise treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial. Diéras, V., Harbeck, N., Joy, AA., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palbociclib: A Review in HR-Positive, HER2-Negative, Advanced or Metastatic Breast Cancer. Kim, ES., Scott, LJ.[2022]

In a study with a median follow-up of about 38 months, palbociclib combined with letrozole significantly improved progression-free survival (PFS) in women with advanced estrogen receptor-positive (ER+)/HER2-negative breast cancer, with a median PFS of 27.6 months compared to 14.5 months for the placebo group.

The treatment not only prolonged PFS but also delayed the need for chemotherapy and maintained a favorable safety profile and quality of life for patients, suggesting that palbociclib-letrozole should be the standard first-line therapy for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Rugo, HS., Finn, RS., Diéras, V., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Palbociclib, an inhibitor of CDK4 and CDK6, was granted accelerated FDA approval for treating advanced breast cancer in postmenopausal women when combined with letrozole, based on a trial involving 165 patients that showed significant improvement in progression-free survival (PFS).

The trial demonstrated a nearly 50% reduction in the risk of disease progression for patients receiving the combination therapy compared to those on letrozole alone, although the most common side effect noted was neutropenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer. Beaver, JA., Amiri-Kordestani, L., Charlab, R., et al.[2022]

Citations

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TBCRC 001: Randomized Phase II Study of Cetuximab in ... Clinical data are controversial. Evidence suggests high responsiveness to cisplatin in BRCA1-associated breast cancer; in non-BRCA1 carriers, neoadjuvant ...

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Comparison and effectiveness of cetuximab alone or ... Cetuximab was being evaluated to see if it could block the epidermal growth factor pathway and stop the cancer from growing either alone or in combination with ...

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A phase 1/2 of a combination of Cetuximab and Taxane for ... 18 triple negative breast cancer patients were treated with weekly Cetuximab and Taxane therapy. Addition of Cetuximab resulted in controllable Dermatologic ...

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Efficacy of cetuximab plus platinum agent in advanced, ... Results: We analyzed 43 patients whom median age at diagnosis was 49 years-old [25-80]. Most of them (81.4%) received platinum and cetuximab as second line or ...

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Phase I Trial of Palbociclib, a Selective Cyclin Dependent ... Overall, 5 of 9 patients (56%) had measureable decreases in target lesions following two cycles of palbociclib and cetuximab (Figure 2). In the 6 of 9 patients ...

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A Phase I Study of the CDK4/6 Inhibitor Palbociclib in ... The primary objective of this study was to describe the safety and tolerability of the combination therapy of palbociclib, cetuximab, and IMRT for locally ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03446157

Palbociclib and Cetuximab in Metastatic Colorectal Cancer Palbociclib is an FDA-approved drug for patients with breast cancer. Palbociclib is not FDA-approved for the treatment of colon cancer, and is considered an ...

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Palbociclib and cetuximab in platinum-resistant and in ... The median overall survival of 9·5 months with palbociclib and cetuximab was better than that with cetuximab monotherapy. In group 2, 19% of patients achieved ...

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Promising Activity Seen With Palbociclib/Cetuximab ... The median OS with palbociclib/cetuximab exceeds the median OS of 7.7 months (95% CI, 5.7-8.8) recorded for patients treated with nivolumab ( ...