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CDK4/6 Inhibitor

Palbociclib + Fulvestrant for Breast Cancer

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prevalence of ESR1 and PI3K mutations

Progression-free survival

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

~3690

Palbociclib

2017

Completed Phase 3

~3760

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

557 Previous Clinical Trials

32,840 Total Patients Enrolled

44 Trials studying Breast Cancer

4,978 Patients Enrolled for Breast Cancer

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,814 Total Patients Enrolled

111 Trials studying Breast Cancer

36,404 Patients Enrolled for Breast Cancer

Vered Stearns, M.D.Study ChairSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4 Previous Clinical Trials

304 Total Patients Enrolled

1 Trials studying Breast Cancer

6 Patients Enrolled for Breast Cancer

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any previous studies which have utilized Fulvestrant?

"Currently, 236 medical studies focussed on Fulvestrant are underway. Of the 42 trials in Phase 3, several can be found in Burgas, New jersey. That said, there is a total of 10932 sites running research related to this drug worldwide."

Answered by AI

What sort of safety profile has Fulvestrant demonstrated?

"Fulvestrant is rated as a 2 on the safety scale due to its Phase 2 status, verifying that there are some data points affirming its security but no studies validating efficacy."

Answered by AI

How widely is this experiment being conducted at present?

"As of now, enrolment for this clinical trial is underway at 6 sites located in Washington, Annapolis and West Reading among other places. To reduce travel distance if you decide to participate, it would be beneficial to select the closest site."

Answered by AI

How many test subjects are partaking in this investigation?

"Unfortunately, recruitment for this clinical trial has ended. The initial post was created on October 25th 2016 and the most recent update occurred on September 15th 2022. For individuals searching other trials, there are currently 2297 medical studies actively looking to enlist participants suffering from malignant neoplasms and 236 trials involving Fulvestrant still welcoming applicants."

Answered by AI

How is Fulvestrant generally employed to treat patients?

"Fulvestrant has been used to successfully combat malignant neoplasms, mutations in the Pik3ca gene, and disease progression."

Answered by AI

Is this research project accepting new participants at the present time?

"This investigation is not presently seeking patients. Originally posted on October 25th 2016, the study was last updated September 15th 2022. For those looking for other investigations involving malignant neoplasms, 2297 trials are actively enrolling subjects and 236 studies recruiting participants to trial Fulvestrant."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor

2016. "Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02738866.

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