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Ribociclib + Fulvestrant for Breast Cancer (MAINTAIN Trial)

Phase 2
Waitlist Available
Led By Melissa Accordino, MD
Research Sponsored by Melissa K Accordino
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Postmenopausal status or receiving ovarian ablation with a GnRH agonist such as goserelin. Postmenopausal status is defined by specific criteria.
Eastern Cooperative Group (ECOG) performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured every 12 weeks, up to 6 months
Awards & highlights

MAINTAIN Trial Summary

This trial is for patients with metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer who have progressed on an aromatase inhibitor plus a CDK4/6 inhibitor. The purpose is to determine whether there is continued benefit for patients to remain on a CDK4/6 inhibitor when switching anti-estrogen therapy.

Who is the study for?
This trial is for adults with HR+ HER2- advanced breast cancer who've progressed after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. They must have measurable disease, be able to swallow pills, and have proper organ function. Postmenopausal women or those on ovarian ablation therapy can join. Exclusions include pregnancy, prior significant chemotherapy in the metastatic setting, uncontrolled medical conditions, recent major surgery or treatments, certain heart conditions, GI issues affecting drug absorption, HIV infection, other cancers within 5 years (with exceptions), and use of certain drugs.Check my eligibility
What is being tested?
The study tests if adding ribociclib (LEE-011) to fulvestrant helps patients with advanced breast cancer who didn't respond well to previous CDK4/6 inhibitors. Participants are randomly assigned to receive either fulvestrant alone or combined with ribociclib. The goal is to see if continuing a CDK4/6 inhibitor offers additional benefits when switching anti-estrogen therapies.See study design
What are the potential side effects?
Ribociclib may cause side effects like low white blood cell counts which can lead to infections; tiredness; nausea; diarrhea; hair thinning; vomiting; constipation; headache and back pain. Fulvestrant's side effects include injection site reactions such as pain or inflammation; nausea; muscle, joint or bone pain.

MAINTAIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am postmenopausal or receiving treatment to stop my ovaries from working.
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I am fully active or can carry out light work.
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I can swallow pills like ribociclib and letrozole or exemestane.
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I am 18 or older with advanced or metastatic breast cancer.
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My latest tumor test shows it is positive for estrogen or progesterone.
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My breast cancer is not HER2 positive according to specific tests.

MAINTAIN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured every 12 weeks, up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured every 12 weeks, up to 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
Percent progression-free at 24 weeks
Secondary outcome measures
Overall Response Rate (ORR) in the fulvestrant/ribociclib group

MAINTAIN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ribociclib (LEE-011)/FulvestrantExperimental Treatment2 Interventions
LEE-011 is administered orally, 600mg, daily for 3 weeks and 1 week off. Fulvestrant is administered intramuscularly, 500mg, every 2 weeks x 3, then every 4 weeks.
Group II: Placebo/FulvestrantPlacebo Group2 Interventions
Placebo is administered orally, 600mg daily for 3 weeks and 1 week off. Fulvestrant is administered intramuscularly, 500mg, every 2 weeks x 3, then every 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690

Find a Location

Who is running the clinical trial?

Melissa K AccordinoLead Sponsor
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,213 Total Patients Enrolled
88 Trials studying Breast Cancer
37,812 Patients Enrolled for Breast Cancer
Melissa Accordino, MDPrincipal InvestigatorColumbia University
3 Previous Clinical Trials
185 Total Patients Enrolled
1 Trials studying Breast Cancer
22 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer
Melissa K Accordino 2016. "Study of Efficacy of Ribociclib After Progression on CDK4/6 Inhibition in Patients With HR+ HER2- Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02632045.
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~15 spots leftby Apr 2025
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