← Back to Search

CDK4/6 Inhibitor

Genetically-informed Therapy for Advanced Breast Cancer (GERTRUDE Trial)

Phase 2

Recruiting

Led By Mary Chamberlin, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-menopausal women ≥18 years of age with metastatic ER+ breast cancer, or with locally recurrent ER+ disease not amenable to therapy for curative intent

Patient must have been treated with a CDK4/6i (either palbociclib, ribociclib, or abemaciclib) alone or in combination with an endocrine agent in the advanced disease setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 - 12 months

Awards & highlights

GERTRUDE Trial Summary

This trial looks to see if certain drug combos can help people with advanced breast cancer who have tried 3 drugs already.

Who is the study for?

This trial is for post-menopausal women aged 18 or older with advanced ER+/HER2- breast cancer, who have been treated with CDK4/6 inhibitors like palbociclib. They can have up to three prior therapies after the inhibitor and one line of chemotherapy. Participants must not be currently on abemaciclib or any investigational cancer therapy within the last three weeks.Check my eligibility

What is being tested?

The study tests combinations of drugs (Abemaciclib, Fulvestrant, Neratinib, Alpelisib, Everolimus) in patients previously treated with CDK4/6 inhibitors. It aims to find effective treatments based on genetic profiles that include specific alterations relevant to the study.See study design

What are the potential side effects?

Potential side effects may include gastrointestinal issues such as diarrhea and nausea; skin reactions; blood clots; fatigue; decreased appetite; changes in liver function tests; and potential risk of infections due to lowered white blood cell counts.

GERTRUDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a post-menopausal woman over 18 with advanced ER+ breast cancer not treatable for a cure.

Select...

I have been treated with a CDK4/6 inhibitor for advanced cancer.

Select...

My tumor or blood sample was tested for specific genes in a certified lab after my cancer progressed.

Select...

My cancer is estrogen receptor positive.

Select...

My breast cancer is estrogen receptor positive, confirmed by a biopsy.

Select...

I've had a PET/CT scan or a CT scan with contrast and a bone scan.

Select...

I am post-menopausal according to NCCN guidelines.

GERTRUDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 - 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 - 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 - 12 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

Rate of clinical benefit within each arm in patients previously treated with a CDK4/6 inhibitor.

Secondary outcome measures

Incidence rate of adverse events within each treatment arm.

Progression-free survival within each treatment arm.

Rate of objective response within each treatment arm.

GERTRUDE Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm D- abemaciclib and fulvestrantExperimental Treatment2 Interventions

If a participant does not have a qualifying mutation/alteration for Arms A/B/C, and the participant does not have mutation or loss of RB1, the subject will be assigned to Treatment Arm D and given the combination of abemaciclib and fulvestrant until the end of the primary treatment phase. Fulvestrant (500 mg) will be administered by intramuscular injection into the buttocks on Cycle 1 Day 1 and Day 15, and on Day 1 of subsequent Cycles. Abemaciclib will be administered orally in 1 tablet (150 mg) taken 2 times per day, in combination with fulvestrant as described above.

Group II: Arm C- everolimus and fulvestrantExperimental Treatment2 Interventions

If a subject does not have a qualifying ERBB2 or PIK3CA mutation, but they have a qualifying mutation/alteration in AKT1, MTOR, or PTEN, the subject will be assigned to Treatment Arm C and given the combination of everolimus and fulvestrant until the end of the primary treatment phase. Fulvestrant (500 mg) will be administered by intramuscular injection into the buttocks on Cycle 1 Day 1 and Day 15, and on Day 1 of subsequent Cycles. Everolimus will be administered orally in 1 tablet (10 mg per tablet) taken 1 time per day, in combination with fulvestrant as described above.

Group III: Arm B- alpelisib and fulvestrantExperimental Treatment2 Interventions

If a participant does not have a qualifying ERBB2 (HER2) mutation, but they have a qualifying PIK3CA mutation, the subject will be assigned to Treatment Arm B and given the combination of alpelisib and fulvestrant until the end of the primary treatment phase. Fulvestrant (500 mg) will be administered by intramuscular injection into the buttocks on Cycle 1 Day 1 and Day 15, and on Day 1 of subsequent Cycles. Alpelisib will be administered orally in 2 tablets (total dose of 300 mg) taken 1 time per day with food, in combination with fulvestrant as described above.

Group IV: Arm A- neratinib and fulvestrantExperimental Treatment2 Interventions

Participants with a qualifying ERBB2 (HER2) mutation will be assigned to Treatment Arm A and given the combination of neratinib and fulvestrant until the end of the primary treatment phase. Fulvestrant (500 mg) will be administered by intramuscular injection into the buttocks on Cycle 1 Day 1 and Day 15, and on Day 1 of subsequent Cycles. Neratinib will initially be administered orally in 3 tablets (total dose of 120 mg) taken 1 time per day with food on Cycle 1 Days 1-7, in combination with fulvestrant starting on Cycle 1 Day 1 as described above. The dose of neratinib will be increased to 4 tablets (total dose of 160 mg) taken 1 time per day with food on Cycle 1 Days 8-14, and then increased further to 6 tablets (240 mg) taken once daily with food thereafter.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1710

Fulvestrant

2011

Completed Phase 3

~3690

Neratinib

2014

Completed Phase 2

~1970

Alpelisib

2018

Completed Phase 3

~900

Everolimus

2010

Completed Phase 4

~1510

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,540,654 Total Patients Enrolled

29 Trials studying Breast Cancer

2,352,830 Patients Enrolled for Breast Cancer

Mary Chamberlin, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center

5 Previous Clinical Trials

93 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05933395 — Phase 2

Breast Cancer Research Study Groups: Arm B- alpelisib and fulvestrant, Arm A- neratinib and fulvestrant, Arm C- everolimus and fulvestrant, Arm D- abemaciclib and fulvestrant

Breast Cancer Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT05933395 — Phase 2

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05933395 — Phase 2

Frequently Asked Questions

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

Is the combination of neratinib and fulvestrant sanctioned by the FDA?

"Through our evaluation at Power, the safety of Arm A- neratinib and fulvestrant is classified as a 2. This rating reflects the fact that this phase 2 trial has some data to support its safety but not yet any for efficacy."

Answered by AI

Is enrollment currently open for the trial?

"As per the information listed on clinicaltrials.gov, this trial is not currently taking in participants for evaluation and treatment. The project was first posted on July 1st 2023 and most recently updated June 28th of the same year. Despite that, there are 2,353 other medical studies actively recruiting now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Mary Chamberlin 2023. "Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05933395.

All > Afinitor