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

NCT07423611 | Not Yet Recruiting Phase 2

• 1 other identifier: CLEE011A0CN03T
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

ribociclib

Outcome Measures

Primary Outcomes (1)

• ctDNA negativity rate

  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 Outcomes (3)

• Invasive disease free survival (IDFS)

  3 years

• Adverse effects(AEs)

  3 years

• Patient reported outcome(PRO)

  3 years

Study Arms (2)

Arm #1: Endocrine+Ribocilcib

EXPERIMENTAL

Aromatase inhibitor (± ovarian suppression) plus Ribocilcib without chemotherapy

Drug: Aromatase inhibitor (± ovarian suppression) plus Ribociclib

Arm #2: TC*4→Endocrine+Ribocilcib

ACTIVE COMPARATOR

4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy, followed by aromatase inhibitor (± ovarian suppression) plus Ribocilcib

Drug: Aromatase inhibitor (± ovarian suppression) plus Ribociclib; Drug: 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

Interventions

Aromatase inhibitor (± ovarian suppression) plus Ribociclib DRUG

Aromatase inhibitor (± ovarian suppression) plus Ribociclib

Arm #1: Endocrine+Ribocilcib; Arm #2: TC*4→Endocrine+Ribocilcib

4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy DRUG

4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

Arm #2: TC*4→Endocrine+Ribocilcib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure
• Patient is female with known menopausal status at the time of randomization
• Patient is ≥ 18 and ≤70 years-old at the time of PICF signature.
• Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis
• Patient has breast cancer that is positive for ER and/or PgR as determined on the most recently analyzed tissue sample
• 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).
• 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:
• \) T0-2N1, 2) T3-4N0, 3) T2N0 meeting the following criteria:
• histological Grade 3,
• 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

You may not qualify if:

• Prior neoadjuvant or adjuvant systemic treatment (including chemotherapy, targeted therapy, or endocrine therapy) for breast cancer
• Bilateral breast cancer
• 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
• Patient has other active malignancies within the past 2 years
• Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial
• Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
• 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
• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Aromatase Inhibitors; Docetaxel; Cyclophosphamide; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Central Study Contacts

Keda Yu, MD, PhD

CONTACT

86-21-64175590-88808; yukeda@fudan.edu.cn

Wenjia Zuo, MD

CONTACT

+86-18017312648; wenjiaz07@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Breast Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 20, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)