Status:
NOT_YET_RECRUITING
Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative ...
Detailed Description
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative ...
Eligibility Criteria
Inclusion
- Females and males aged 18-70 years;
- ECOG performance status 0-1;
- Early-stage breast cancer, with postoperative pathology confirming invasive carcinoma, HR-positive and HER2-negative (In this study, HR-positive is defined as: ER-positive by IHC with \>10% tumor cells staining positive; HER2-negative defined as HER2 0-1+ by IHC or HER2++ with negative FISH result, without amplification);
- Postoperative pathological stage pT2N0M0 and:
- Histological grade 3, or Histological grade 2 with Ki67 ≥ 20% or high-risk multigene assay results;
- No prior neoadjuvant therapy received;
- Good postoperative recovery, with randomization occurring no more than 8 weeks after surgery;
- Normal function of major organs, meeting the following criteria:
- Hematological tests must meet: HB ≥90 g/L (no transfusion within 14 days); ANC ≥1.5×10⁹/L; PLT ≥100×10⁹/L; Biochemical tests must meet: TBIL ≤1.5×ULN (upper limit of normal); ALT and AST ≤3×ULN; serum Cr ≤1.5×ULN;
- Contraception required for male participants and women of childbearing potential during treatment;
- Participants voluntarily enroll in the study, sign informed consent, demonstrate good compliance, and cooperate with follow-up.
Exclusion
- Bilateral breast cancer or carcinoma in situ (DCIS/LCIS);
- Metastasis at any site;
- Clinical or imaging suspicion of malignancy in the contralateral breast requiring biopsy (unless ruled out);
- Prior neoadjuvant therapy, including chemotherapy, radiotherapy, or endocrine therapy;
- Use of tamoxifen, raloxifene, or aromatase inhibitors (AIs) for breast cancer risk reduction ("chemoprevention") and/or osteoporosis treatment within the past 2 years;
- History of other malignancies within the past 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix), including contralateral breast cancer;
- Concurrent participation in another clinical trial;
- Severe systemic diseases and/or uncontrolled infections that preclude study participation;
- Severe cardiovascular or cerebrovascular events within 6 months before randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90 mmHg, myocardial infarction, or stroke);
- Known hypersensitivity to the study drugs;
- Men and women of childbearing potential unwilling to use contraception during treatment and for 8 weeks after treatment completion;
- Pregnant or lactating women;
- Positive pregnancy test before study drug administration (for women of childbearing potential);
- Psychiatric disorders, cognitive impairment, or inability to comprehend the trial protocol, adverse effects, or comply with study procedures and follow-up (requires systematic evaluation before enrollment);
- Individuals lacking personal freedom or legal capacity for independent civil conduct.
Key Trial Info
Start Date :
June 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2034
Estimated Enrollment :
2508 Patients enrolled
Trial Details
Trial ID
NCT06996093
Start Date
June 2 2025
End Date
June 1 2034
Last Update
May 30 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032