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Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

NCT05467891•Oana Danciu

View on ClinicalTrials.gov

Summary

This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

Detailed Description

Collection of Correlative Samples at First Recurrence (Stage I consent) If feasible, optional correlative blood and fresh tissue will be collected during surgical excision of their 1st recurrence. Patients should then complete radiation therapy if that is indicated. Enrollment to the Treatment Phase will occur within 6 months of the last local treatment, surgery or radiation treatment, whichever occurred last. Study Treatment (Stage II/ main consent) Treatment includes: 1. Ribociclib: Oral ribociclib at a dose of 400 mg daily for 21 days out of a 28-day cycle. Ribociclib will be used in combination with ET per physician choice. 2. Physician's Choice Endocrine Therapy: ET consists of one of the following: * Intramuscular fulvestrant * Oral anastrozole * Oral letrozole * Oral exemestane * Concomitant use with tamoxifen is not allowed. Ribociclib administration is planned for 36 months and ET administration is planned for 60 months.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Eligibility Criteria to Collect Optional Correlative Blood and Tissue at Local Recurrence
•Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
•Male or female age ≥ 18 years at the time of consent.
•Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
•Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.
•Patient has locoregional recurrence of breast cancer: locoregional recurrence is defined as invasive recurrence in the ipsilateral breast, axilla, regional nodes, or chest wall.
•Written informed consent (stage II/ main consent) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
•Male or female age ≥ 18 years at the time of consent. NOTE: Both pre- and post-menopausal women are eligible. Post-menopausal status is defined as:
•* Prior bilateral oophorectomy
•* Age ≥60
+33 more criteria

Exclusion Criteria

•Subjects meeting any of the criteria below may not participate in the study:
•Patient with a known hypersensitivity to any of the excipients of ribociclib.
•Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
•Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
•Pregnant or breastfeeding or planning to become pregnant during the trial (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
•Patients with distant metastases of breast cancer beyond regional lymph nodes as defined by AJCC (8th edition).
•Treatment with any investigational drug within 30 days prior to registration or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. Enrollment or planned enrollment in another study that does not involve an investigational drug will be allowed at the discretion of the treating investigator.
•Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
•Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g., chronic pancreatitis, chronic active hepatitis, HIV, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). Testing to be done at investigator's discretion.
•Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:
+14 more criteria

Locations (20)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Arizona

Phoenix, Arizona, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

University of Illinois Cancer Center

Chicago, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Tufts Medical Center

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

University of Michigan Health-West

Wyoming, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Key Dates

Start Date

September 13, 2022

Primary Completion Date

August 1, 2028

Completion Date

August 1, 2029

Last Updated

February 27, 2026

Enrollment

200

ESTIMATED participants

Conditions

Locoregional RecurrenceHormone Receptor-positive Breast CancerHER2-negative Breast Cancer

Interventions

Ribociclib

DRUG

Fulvestrant

DRUG

Anastrozole

DRUG

Letrozole

DRUG

Exemestane

DRUG

Contacts

Oana Danciu, MD

CONTACT

312-996-1581 ocdanciu@uic.edu

Rebecca Mottier

CONTACT

317-634-5842 rmottier@hoosiercancer.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

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