Palbociclib + Fulvestrant for Breast Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Jessica Tao, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is being done to look at the role of continuing palbociclib treatment in combination with another type of hormonal therapy (fulvestrant) after disease progression of palbociclib in combination with an aromatase inhibitor.

Research Team

Jessica Tao, MD

Principal Investigator

SKCCC Johns Hopkins Medical Institution

Vered Stearns, M.D.

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria

This trial is for women with metastatic or advanced breast cancer that worsened after at least 6 months of palbociclib and an aromatase inhibitor. They must have had no more than one chemotherapy for advanced disease, no prior fulvestrant or certain other treatments, and should be in a stable condition if they've had brain metastasis or recent radiation.

Inclusion Criteria

I am either before or after menopause.

My breast cancer cannot be removed by surgery or cured with radiation.

My tumor is positive for estrogen or progesterone receptors and negative for HER2.

Exclusion Criteria

I haven't had major cancer treatment or surgery in the last 2 weeks.

I have not had a severe heart problem in the last 6 months.

I have had a bone marrow or stem cell transplant.

Treatment Details

Interventions

• Fulvestrant (Estrogen Receptor Antagonist)
• Palbociclib (CDK4/6 Inhibitor)

Trial Overview The study tests the effectiveness of continuing palbociclib alongside fulvestrant after initial progression on palbociclib with an aromatase inhibitor. It aims to understand if this combination can further help control the disease.

Participant Groups

Group I: Palbociclib and Fulvestrant Experimental Treatment 2 Interventions

Participants will receive fulvestrant with palbociclib until 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

Research Locations Nearby Select from list below to view details:

Johns Hopkins Baltimore, MD

Allegheny Health Network (AHN) - Allegheny General Hospital ONLY Pittsburgh, PA

Anne Arundel Health System Research Institute, Inc. Annapolis, MD

Reading Hospital - McGlinn Cancer Institute West Reading, PA

More Trial Locations

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Patients Recruited

33,600+

Pfizer

Industry Sponsor

Trials

4712

Patients Recruited

50,980,000+

Known For

Vaccine Innovations

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