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Clinical Trials in China / NCT07423611
Starting soon Phase 2

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

NCT07423611 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 2
Started
2026-10-01
Last updated
2026-02-20

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Aromatase inhibitor (± ovarian suppression) plus RibociclibAll Aromatase inhibitor trials (8) →All Ribociclib trials (35) →4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy →

Aromatase inhibitor (± ovarian suppression) plus Ribociclib: Aromatase inhibitor (± ovarian suppression) plus Ribociclib

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality

More Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07423611 on ClinicalTrials.gov ↗ ← All trials in China