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CDK4/6 Inhibitor

Palbociclib + Fulvestrant for Breast Cancer

Phase 2
Waitlist Available
Led By Jessica Tao, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic or locally advanced breast cancer, not amenable to surgery or radiation with curative intent
ER-positive and/or PR-positive, HER2-negative tumor
Must not have
Concurrent use of inhibitors or inducers of CYP3A4, or medications which prolong the QTc interval
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration; prior radiotherapy to ≥25% of bone marrow are not eligible independent of when it was received
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is to see if continuing treatment with palbociclib and adding fulvestrant helps people with hormone-receptor positive breast cancer who have progressed on palbociclib and an aromatase inhibitor.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include low blood counts leading to increased infection risk, fatigue, nausea, hair thinning, neuropathy (nerve pain), and potential allergic reactions to medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer cannot be removed by surgery or cured with radiation.
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My tumor is positive for estrogen or progesterone receptors and negative for HER2.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer can be measured or seen on tests.
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My condition can be checked with a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking drugs that affect enzyme CYP3A4 or change heart rhythm.
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I haven't had major cancer treatment or surgery in the last 2 weeks.
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I have not had a severe heart problem in the last 6 months.
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I have had a bone marrow or stem cell transplant.
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I am HIV positive.
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I am not pregnant or breastfeeding.
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I cannot have certain injections due to bleeding issues or being on blood thinners.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prevalence of ESR1 and PI3K mutations
Progression-free survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Palbociclib and FulvestrantExperimental Treatment2 Interventions
Participants will receive fulvestrant with palbociclib until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3520
Palbociclib
2017
Completed Phase 3
~3880

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,170 Total Patients Enrolled
45 Trials studying Breast Cancer
4,972 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,649 Previous Clinical Trials
17,744,316 Total Patients Enrolled
114 Trials studying Breast Cancer
41,346 Patients Enrolled for Breast Cancer
Jessica Tao, MDPrincipal InvestigatorSKCCC Johns Hopkins Medical Institution

Media Library

Palbociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02738866 — Phase 2
Breast Cancer Research Study Groups: Palbociclib and Fulvestrant
Breast Cancer Clinical Trial 2023: Palbociclib Highlights & Side Effects. Trial Name: NCT02738866 — Phase 2
Palbociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02738866 — Phase 2
~0 spots leftby Dec 2024
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