ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer (RACE)

February 14, 2026 updated by: Keda Yu, Fudan University

A Multicenter, Open-label, Randomized Controlled Clinical Study Comparing the Efficacy and Safety of ctDNA-guided Ribociclib Plus Endocrine Therapy Versus Chemotherapy Followed by Ribociclib Plus Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, multicenter, open-label, randomized controlled clinical trial designed to determine whether ribociclib plus endocrine therapy (ET) is non-inferior to adjuvant chemotherapy followed by ribociclib plus ET in patients with circulating tumor DNA (ctDNA)-negative, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer.

Patients with HR+/HER2- early breast cancer who have undergone definitive surgery will be enrolled and must undergo ctDNA-MRD analysis within 4 weeks after surgery. Patients who are ctDNA negative will be randomly assigned (1:1) to two study groups, according to stratification factors: menopausal status (premenopausal vs. postmenopausal). The experimental group will receive ribociclib plus aromatase inhibitor (AI) or ovarian function suppression (OFS), while the control group will receive chemotherapy followed by ribociclib plus AI or OFS. The safety and efficacy of each group will be assessed through ctDNA nagative rate, invasive disease free survival (iDFS), and adverse effects (AE) as graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and patient reported outcome (PRO).

Study Type

Interventional

Enrollment (Estimated)

388

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Keda Yu, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure
  2. Patient is female with known menopausal status at the time of randomization
  3. Patient is ≥ 18 and ≤70 years-old at the time of PICF signature.
  4. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis
  5. Patient has breast cancer that is positive for ER and/or PgR as determined on the most recently analyzed tissue sample
  6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample).
  7. Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:

1) T0-2N1, 2) T3-4N0, 3) T2N0 meeting the following criteria:

  1. histological Grade 3,
  2. histological Grade 2 with Ki-67 proliferation index ≥20% or/and high genomic risk 8. Eligible to adjuvant chemotherapy per investigator's decision (Based on clinicopathological findings or genomic assay results) 9. ECOG Performance Status of 0 or 1 10. ctDNA-MRD negative within 4 weeks post-surgery 11. Adequate hematological, renal, and hepatic function

Exclusion Criteria:

  1. Prior neoadjuvant or adjuvant systemic treatment (including chemotherapy, targeted therapy, or endocrine therapy) for breast cancer
  2. Bilateral breast cancer
  3. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery
  4. Patient has other active malignancies within the past 2 years
  5. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
  6. Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
  7. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to a NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0 Grade ≤ 1 at day of randomization
  8. Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm #1: Endocrine+Ribocilcib
Aromatase inhibitor (± ovarian suppression) plus Ribocilcib without chemotherapy
Drug: Aromatase inhibitor (± ovarian suppression) plus Ribociclib
Aromatase inhibitor (± ovarian suppression) plus Ribociclib
Active Comparator: Arm #2: TC*4→Endocrine+Ribocilcib
4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by aromatase inhibitor (± ovarian suppression) plus Ribocilcib
Drug: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
Drug: Aromatase inhibitor (± ovarian suppression) plus Ribociclib
Aromatase inhibitor (± ovarian suppression) plus Ribociclib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ctDNA negativity rate
Time Frame: 3 years

Definition of ctDNA negativity: Up to the assessment time point, no ctDNA-positive result has been reported. A patient is considered ctDNA-positive if at least one clinically significant mutation is detected, or if at least two variants of uncertain significance (VUS) are detected.

3-year ctDNA negativity rate: (n1 - n2) / n1

n1: total number of enrolled patients in each treatment group n2: number of patients in each treatment group who convert to ctDNA-positive on any test within 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive disease free survival (IDFS)
Time Frame: 3 years
Invasive disease-free survival (IDFS), defined as occurrence of any of the following: ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or second non-breast invasive cancer.
3 years
Adverse effects(AEs)
Time Frame: 3 years
Adverse effects graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0
3 years
Patient reported outcome(PRO)
Time Frame: 3 years
Information about a patient's health that comes directly from the patient. Examples of patient-reported outcomes include a patient's description of their symptoms, their satisfaction with care, and how a disease or treatment affects their physical, mental, emotional, spiritual, and social well-being. Lower scores in European Organization for Research and Treatment of Cancer(EORTC) QLQ-BR45 questionnaire will mean a better outcome.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

February 14, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEE011A0CN03T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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