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CDK 4/6 Inhibitor

Endocrine Therapy + CDK4/6 Inhibitor for Breast Cancer

Phase 2
Recruiting
Led By Jessica Tao, M.D.
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
Treatment naïve in metastatic or locally advanced setting and planning to undergo treatment with endocrine therapy (ET) and palbociclib OR receiving first-line ET and palbociclib for metastatic or locally advanced disease
Metastatic (stage IV) breast cancer or locally advanced breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is studying if a CDK4/6 inhibitor combined with endocrine therapy can help treat subjects with ER+ and/or PR+ metastatic breast cancer.

Who is the study for?
This trial is for men and women over 18 with newly diagnosed ER+/PR+ metastatic or advanced breast cancer, who are treatment-naive or on their first-line therapy with endocrine therapy and palbociclib. Participants must not be pregnant, nursing, or have had another primary cancer in the last 5 years (except certain skin cancers).Check my eligibility
What is being tested?
Researchers are testing if they can predict who will respond to endocrine therapy combined with a CDK4/6 inhibitor for treating metastatic breast cancer by analyzing tumor tissue and blood samples. The study aims to personalize future therapies based on these predictions.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from endocrine therapy and CDK4/6 inhibitors include fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk, liver issues, hair thinning or loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am about to start or am currently on my first treatment with ET and palbociclib for advanced cancer.
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My breast cancer is advanced or has spread to other parts of my body.
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I have tissue from a metastatic site collected in the last 6 months.
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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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I am premenopausal or a man and am receiving LHRH agonist treatment.
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I am 18 years old or older.
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My cancer is positive for ER/PR and negative for HER2.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Genetic Mutation

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B: Participants initiating a CDK 4/6 i after progression on ET.Experimental Treatment1 Intervention
Participants will undergo blood collection (intervention) at time of initiating treatment with endocrine therapy and palbociclib, at 4 weeks after initiating this treatment, and every 3-4 months while on treatment. If a participant progresses on this treatment, they will have a blood collection at that time.
Group II: Cohort A: Participants with untreated metastatic disease receiving ET and a CDK 4/6Experimental Treatment1 Intervention
Participants will undergo blood collection (intervention) at time of initiating treatment with endocrine therapy and palbociclib, at 4 weeks after initiating this treatment, and every 3-4 months while on treatment. If a participant progresses on this treatment, they will have a blood collection at that time.

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,780 Total Patients Enrolled
43 Trials studying Breast Cancer
4,878 Patients Enrolled for Breast Cancer
Jessica Tao, M.D.Principal InvestigatorJohns Hopkins University
Maria Nunes, M.D.Principal InvestigatorSibley Memorial Hospital

Media Library

CDK4/6 Inhibitor (CDK 4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03439735 — Phase 2
Breast Cancer Research Study Groups: Cohort A: Participants with untreated metastatic disease receiving ET and a CDK 4/6, Cohort B: Participants initiating a CDK 4/6 i after progression on ET.
Breast Cancer Clinical Trial 2023: CDK4/6 Inhibitor Highlights & Side Effects. Trial Name: NCT03439735 — Phase 2
CDK4/6 Inhibitor (CDK 4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03439735 — Phase 2

Frequently Asked Questions

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

Are seniors being accepted into the research project?

"Based on the qualifications outlined in this study, candidates must be over 18 years of age and younger than 100."

Answered by AI

Are there still openings to join this trial?

"The clinical trial website states that this study is presently enrolling participants. It was first advertised on July 20th 2018 and the most recent update to its information occured on July 18th 2022."

Answered by AI

Is Endocrine Therapy coupled with a CDK 4/6 inhibitor deemed safe for the patient demographic?

"We have assigned Endocrine Therapy and a CDK 4/6 inhibitor an overall safety rating of 2, as this is the second-phase trial. While there are data supporting its safety, efficacy has yet to be established."

Answered by AI

How many individuals are actively contributing to the research endeavor?

"Affirmative. Clinicaltrials.gov attests to the ongoing recruitment for this trial, which was initially posted on July 20th 2018 and subsequently modified on July 18th 2022. This research is looking to enrol 100 volunteers at 2 distinct medical facilities."

Answered by AI

Am I eligible to join this experimental trial?

"This medical trial seeks 100 individuals suffering from breast cancer, with ages ranging between 18 and 100. The necessary criteria to apply is gender (male or female), being over the age of consent, Eastern Cooperative Oncology Group performance status 0-2, metastatic stage IV or locally advanced breast cancer not yet treated by therapy involving endocrine treatment and palbociclib OR first line ET & palbociclib for metastatic/localised disease, evaluable/measurable pathology data present in tissue collected within 6 months prior to initiating therapy."

Answered by AI
~15 spots leftby Mar 2025