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Recruiting Phase 3

CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon）

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About this study

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.

Condition
Breast Cancer
Tested
Dalpiciclib+AI ± OFS, TC (Docetaxel + Cyclophosphamide) × 4 cycles- endocrine therapy
Sponsor
Fudan University

Who can join

Age
18 to 70 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Maximum age: 70 years
  • Eligible sex: Female
  • Study condition: Breast Cancer
  • Female, aged 18 to 70 years.
  • Histologically confirmed early breast cancer with pathological stage T1N0, 0.5 cm \< tumor size ≤ 2 cm, ER-positive/HER2-negative, with ER expression ≥ 50%; and willingness to receive adjuvant dalpiciclib treatment.
  • 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.
  • ECOG performance status: 0 to 1.
  • 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).
  • Voluntary participation with written informed consent, good compliance, and willingness to comply with follow-up requirements.

Exclusion 12

  • Patients who have received neoadjuvant therapy, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.
  • Bilateral breast cancer.
  • History of other prior malignancies, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.
  • \) Evidence of metastasis at any site. 5) Any T4 lesion (UICC 1987), including skin involvement, tumor fixation/mass, or inflammatory breast cancer.
  • \) Pregnant or lactating women, or women of childbearing potential who are unwilling to use adequate contraception.
  • \) 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.
  • \) 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.
  • Patients deemed by the investigator to be unsuitable for participation in this study.
  • Patient refusal to receive adjuvant dalpiciclib treatment.

Where

1 site, 1 recruiting

Fudan University Shanghai Cancer Center

Shanghai, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.