A Phase 2 interventional study of Aromatase inhibitor (± ovarian suppression) plus Ribociclib and 4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy in Breast Cancer, sponsored by Fudan University. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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.
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).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 388 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
Counted across the registry records on this site, refreshed daily.
1) T0-2N1, 2) T3-4N0, 3) T2N0 meeting the following criteria:
Exclusion Criteria:
Aromatase inhibitor (± ovarian suppression) plus Ribocilcib without chemotherapy
Drug: Aromatase inhibitor (± ovarian suppression) plus Ribociclib
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
Aromatase inhibitor (± ovarian suppression) plus Ribociclib
4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy
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
Time frame: 3 years
Invasive disease free survival (IDFS)
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.
Time frame: 3 years
Adverse effects(AEs)
Adverse effects graded by Common Terminology Criteria for Adverse Events (CTCAE) 5.0
Time frame: 3 years
Patient reported outcome(PRO)
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.
Time frame: 3 years
Plan to share: No
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Fudan University