5796 Participants Needed

Palbociclib + Endocrine Therapy for Breast Cancer

(PALLAS Trial)

Recruiting at 438 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Alliance Foundation Trials, LLC.
Must be taking: Adjuvant hormonal
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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 take medications that strongly affect CYP3A enzymes within 7 days before starting the trial. You also cannot be on antiretroviral therapy or other investigational drugs.

What data supports the effectiveness of the drug Palbociclib when used with endocrine therapy for breast cancer?

Research shows that adding Palbociclib to endocrine therapy improves progression-free survival (the time during which the cancer does not get worse) in patients with hormone-receptor-positive, HER2-negative metastatic breast cancer. This suggests that Palbociclib can enhance the effectiveness of endocrine therapy in treating certain types of breast cancer.12345

Is Palbociclib combined with endocrine therapy safe for humans?

Palbociclib combined with endocrine therapy has been generally well-tolerated in studies, though common side effects include low white blood cell counts (neutropenia and leukopenia) and mouth sores (stomatitis). Serious side effects like fever with low white blood cell count (febrile neutropenia) were rare, and overall, patients did not experience a significant decline in quality of life.56789

How is the drug palbociclib plus endocrine therapy unique for breast cancer treatment?

Palbociclib plus endocrine therapy is unique because it combines a cyclin-dependent kinase 4/6 inhibitor with hormone therapy, which helps to significantly prolong progression-free survival in patients with hormone receptor-positive, HER2-negative advanced breast cancer compared to hormone therapy alone.3781011

What is the purpose of this trial?

This trial is testing whether adding the drug palbociclib to standard hormone therapy can improve treatment for patients with a specific type of early breast cancer. The targeted patients have hormone receptor-positive and HER2-negative breast cancer. Palbociclib works by blocking proteins that help cancer cells grow, potentially making the hormone therapy more effective.

Research Team

Erica Mayer, MD, MPH - Dana-Farber

Erica L. Mayer, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Angela DeMichele, MD, MSCE profile ...

Angela DeMichele, MD

Principal Investigator

University of Pennsylvania

EG

Evanthia Galanis, MD

Principal Investigator

Alliance Foundation Trials, LLC.

MG

Michael Gnant, MD

Principal Investigator

ABCSG, Medical University Vienna

Eligibility Criteria

This trial is for adults over 18 with HR+/HER2- early breast cancer (Stage II or III), who have had surgery, can take oral meds, and are on or starting hormone treatment. They must not be pregnant, have normal organ function tests, no history of other cancers, and no severe illnesses that could affect participation.

Inclusion Criteria

Women who can have babies must have a negative pregnancy test within 14 days before starting the trial.
I have completed my initial cancer treatment and my side effects have mostly gone away.
I have had surgery to remove my breast cancer.
See 18 more

Exclusion Criteria

Concurrent therapy with other Investigational Products.
I am currently on hormone therapy, but topical vaginal estrogen is okay.
My breast cancer is not Stage I or IV.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive palbociclib in addition to standard adjuvant endocrine therapy for 2 years

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

  • Palbociclib
  • Standard Adjuvant Endocrine Therapy
Trial Overview The study is testing if adding palbociclib to standard endocrine therapy after breast cancer surgery improves patient outcomes compared to endocrine therapy alone. It's a Phase III trial where patients are randomly assigned to two groups in an open-label setting.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
Standard adjuvant endocrine therapy for a duration of at least 5 years.
Group II: Arm AExperimental Treatment2 Interventions
Palbociclib at a dose of 125 mg orally once daily, Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle for a total duration of 2 years, in addition to standard adjuvant endocrine therapy for a duration of at least 5 years.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alliance Foundation Trials, LLC.

Lead Sponsor

Trials
25
Recruited
27,200+

Austrian Breast & Colorectal Cancer Study Group

Collaborator

Trials
23
Recruited
18,500+

NSABP Foundation Inc

Collaborator

Trials
89
Recruited
140,000+

PrECOG, LLC.

Collaborator

Trials
19
Recruited
8,000+

Breast International Group

Collaborator

Trials
34
Recruited
53,600+

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

In a phase II trial involving 71 patients with HER2-positive advanced breast cancer, the combination of palbociclib and trastuzumab showed promising progression-free survival rates, particularly in estrogen receptor-positive patients, with rates of 42.8% and 46.4% for different cohorts.
The treatment was generally safe, but a high incidence of grade 1-2 (97.7%) and grade 3-4 (84.4%) toxicities was observed, with neutropenia being the most common severe side effect, indicating the need for careful monitoring during treatment.
Palbociclib and Trastuzumab in HER2-Positive Advanced Breast Cancer: Results from the Phase II SOLTI-1303 PATRICIA Trial.Ciruelos, E., Villagrasa, P., Pascual, T., et al.[2021]
In a phase III trial involving 601 patients with aromatase inhibitor-resistant metastatic breast cancer, palbociclib combined with endocrine therapy did not show superior progression-free survival compared to capecitabine, with median PFS of 7.5 months versus 10.0 months in the second cohort.
However, palbociclib plus endocrine therapy had a better safety profile, with fewer severe side effects and improved quality of life for patients compared to capecitabine.
Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial-PEARL.Martin, M., Zielinski, C., Ruiz-Borrego, M., et al.[2022]
In a study of 521 premenopausal and postmenopausal patients with endocrine-resistant metastatic breast cancer, those treated with palbociclib and fulvestrant showed a higher rate of prolonged benefit (29%) compared to those on placebo and fulvestrant (15%).
Long-term responders to palbociclib-fulvestrant tended to have less disease burden at baseline and lower rates of certain mutations, but no specific molecular or clinical factors were identified as predictors of long-term benefit.
Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3.Cristofanilli, M., DeMichele, A., Giorgetti, C., et al.[2022]

References

Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. [2022]
Palbociclib and Trastuzumab in HER2-Positive Advanced Breast Cancer: Results from the Phase II SOLTI-1303 PATRICIA Trial. [2021]
Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial-PEARL. [2022]
Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3. [2022]
Palbociclib in Combination With Fulvestrant in Women With Hormone Receptor-Positive/HER2-Negative Advanced Metastatic Breast Cancer: Detailed Safety Analysis From a Multicenter, Randomized, Placebo-Controlled, Phase III Study (PALOMA-3). [2022]
Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. [2023]
Efficacy and safety of palbociclib plus endocrine therapy in North American women with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. [2022]
Palbociclib-letrozole as first-line treatment for advanced breast cancer: Updated results from a Japanese phase 2 study. [2021]
Real-World Effectiveness of Palbociclib Versus Clinical Trial Results in Patients With Advanced/Metastatic Breast Cancer That Progressed on Previous Endocrine Therapy. [2022]
Efficacy of palbociclib plus fulvestrant after everolimus in hormone receptor-positive metastatic breast cancer. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Palbociclib for the Treatment of Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer. [2021]
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