A Phase 3 interventional study of Dalpiciclib+AI ± OFS and TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy in Breast Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Fudan University · Phase 3, Interventional, and Treatment
This study is a Phase III non-inferiority trial targeting a specific subset of early breast cancer patients: those with HR-positive/HER2-negative, node-negative small tumors (typically ≤2cm) but who exhibit high-risk features for recurrence (such as high histological grade, high Ki-67 index, etc.). Currently, the standard adjuvant treatment for these patients often includes chemotherapy followed by endocrine therapy, despite their small tumor size, due to the high-risk biological characteristics. However, chemotherapy can bring significant toxicity and long-term side effects.
This trial explores whether a chemotherapy-sparing approach is feasible. It compares the efficacy and safety of using the CDK4/6 inhibitor Dalpiciclib combined with endocrine therapy (AI ± OFS) directly, without chemotherapy, against the traditional approach of chemotherapy (TC regimen) followed by endocrine therapy. The primary goal is to demonstrate that the chemotherapy-free regimen is not inferior to the chemotherapy-containing regimen in terms of 5-year invasive disease-free survival (iDFS). If successful, this study could potentially de-escalate treatment for this high-risk population, sparing them from chemotherapy-related toxicities while maintaining excellent oncological outcomes.
Presence of at least one of the following high-risk features:
Ki-67 index ≥ 50%; Grade 3 (G3) tumor; an indication for chemotherapy based on results from multigene assays, including the 21-gene recurrence score and the 70-gene signature ; Age ≤ 40 years.
Adequate organ function, defined as meeting the following criteria:
Hematology (no blood transfusion within 14 days): Hemoglobin (HB) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L; Platelet (PLT) ≥ 100 × 10⁹/L.
Biochemistry: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3 × ULN; Serum Creatinine (Cr) ≤ 1 × ULN, with creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault formula).
Exclusion Criteria:
4) Evidence of metastasis at any site. 5) Any T4 lesion (UICC 1987), including skin involvement, tumor fixation/mass, or inflammatory breast cancer.
6) Pregnant or lactating women, or women of childbearing potential who are unwilling to use adequate contraception.
7) Concurrent participation in another clinical trial. 8) Severe organ dysfunction (cardiac, pulmonary, hepatic, or renal). Left Ventricular Ejection Fraction (LVEF) \< 50% (by echocardiography). History of severe cardiovascular or cerebrovascular disease within 6 months prior to randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90 mmHg, myocardial infarction, or cerebrovascular accident). Patients with poorly controlled diabetes mellitus or severe hypertension.
9) Known hypersensitivity to taxanes or their excipients. 10)Severe or uncontrolled infection. 11)History of psychoactive substance abuse that cannot be discontinued, or history of mental disorders.
12)Patients deemed by the investigator to be unsuitable for participation in this study.
13)Patient refusal to receive adjuvant dalpiciclib treatment.
Drug: Dalpiciclib+AI ± OFS
Drug: TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy
Chemotherapy-free regimen Dalpiciclib 125mg qd d1-d21 Q4W orally for 2 years Combined with AI (at least 5 years) ± OFS
TC (Docetaxel + Cyclophosphamide) × 4 cycles Endocrine therapy according to current indications and physician's choice
iDFS
It is defined as the percentage of patients who remain free of invasive disease recurrence, secondary primary invasive cancers, or death from any cause over a 5-year period from randomization or initiation of study treatment.
Time frame: 5 years
DFS
It measures the proportion of patients who remain free of detectable disease (including recurrence, progression, or new primary cancer) and alive for 5 years after starting treatment or randomization.
Time frame: 5 years
DDFS
5-year DDFS is an oncology clinical trial endpoint that specifically measures the proportion of patients who remain free of distant metastasis (spread of cancer to remote organs) and death from the cancer within 5 years after initiation of study treatment or randomization. It focuses exclusively on distant metastatic events rather than all disease recurrences.
Time frame: 5 years
RFS
5-year RFS is an oncology clinical trial endpoint that measures the proportion of patients who remain free of disease recurrence (local, regional, or distant) for 5 years following curative-intent treatment (typically surgery). It specifically focuses on recurrence of the original primary cancer and does not include new primary cancers unrelated to the initial diagnosis.
Time frame: 5 years
OS
Overall Survival (OS) is the gold standard efficacy endpoint in oncology clinical trials, defined as the time from randomization (or treatment initiation) to death from any cause. It represents the most objective and clinically meaningful measure of treatment benefit, directly reflecting whether a therapy prolongs patients' lives.
Time frame: 5 years
Safety and Tolerability
Safety and Tolerability Will be Assessed According to Standard (CTCAE Version 5.0) Toxicity Reporting Criteria.
Time frame: 5 years
Quality of Life score in the per-protocol population
The quality of life of patients was assessed using the EORTC QLQ-C30 questionnaire before, during, and after treatment.
Time frame: 5 years
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