ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Neg… (NCT07423611) | Clinical Trial Compass
Not Yet RecruitingPhase 2
ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer
China388 participantsStarted 2026-10-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. 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:
✓. histological Grade 3,
Exclusion criteria
✕. 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