Chemotherapy-free therapy with a CDK4/6 inhibitor for small high-risk ER-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, non-inferiority study comparing a chemotherapy-free regimen (dalpiciclib plus endocrine therapy with or without ovarian function suppression) to the standard chemotherapy plus endocrine therapy in women with small, high-risk HR-positive/HER2-negative breast cancer. Eligible patients have tumors 0.5–2 cm, ER ≥50%, and additional high-risk features such as high Ki-67, grade 3, or indications from multigene assays. Primary goal is to show the chemotherapy-free approach is not worse than the chemotherapy-containing regimen in terms of efficacy, while potentially reducing chemotherapy-related toxicity. The study will also monitor safety, tolerability, and quality of life. Lead sponsor is Fudan University, with the trial conducted at Fudan University Shanghai Cancer Center in Shanghai, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female, aged 18 to 70 years.
2. 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.
3. 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.
4. ECOG performance status: 0 to 1.
5. 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).
6. Voluntary participation with written informed consent, good compliance, and willingness to comply with follow-up requirements.

Exclusion Criteria:

1. Patients who have received neoadjuvant therapy, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.
2. Bilateral breast cancer.
3. History of other prior malignancies, except for curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Zhimin Shao — Fudan U
• Study coordinator: Zhimin Shao Professor
• Email: zhimingshao@yahoo.com
• Phone: 08664175590 Ext. Ext. 88807

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.