NCT06637150Active, not recruitingPhase 3
A Phase III Randomized Controlled Trial Comparing Dalpicilib-Enhanced Adjuvant Endocrine Therapy with Standard Adjuvant Endocrine Therapy in ER+ HER2- Lymph Node-Negative Early Breast Cancer with Risk Factors
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Fudan University
- Enrollment
- 1,388
- Locations
- 1
- Primary Endpoint
- Invasive Disease Free Survival
Study Overview
Brief Summary
This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant endocrine therapy in breast cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 18-70 years
- •ECOG score of 0-1
- •Histologically confirmed unilateral invasive cancer (regardless of pathology type)
- •No macroscopic or microscopic tumor residue after surgical resection
- •Early-stage breast cancer, pathologically confirmed as ER-positive and HER2-negative (ER-positive defined as immunohistochemical detection of ER >10% of tumor cells positive; HER2 0-1+ or HER2 2+ but FISH negative, with no amplification, defined as HER2-negative)
- •Postoperative pathological staging of pT1c or above, N0M0, and meeting one of the following criteria: (1) G3; (2) G2 and meeting one of the following: i. Ki-67 ≥20%; ii. 21-gene recurrence score ≥26 or high genomic risk profile; iii. Age ≤40 years and vascular invasion positive
- •No prior neoadjuvant treatment
- •Time from surgery or completion of chemotherapy or radiotherapy (whichever occurs later) to randomization does not exceed 8 weeks
- •Good postoperative recovery, at least 1 week after surgery
- •Normal function of major organs, meeting the following criteria: (1) Hematological criteria: HB ≥90 g/L (no blood transfusion in the last 14 days); ANC ≥1.5 × 10^9 /L; PLT ≥100 × 10^9 /L; (2) Biochemical criteria: TBIL ≤1.5 × ULN (upper limit of normal); ALT and AST ≤3 × ULN; serum Cr ≤1.5 × ULN
- •Women of childbearing age must use contraception during treatment
- •Subjects voluntarily join this study, sign informed consent, demonstrate good compliance, and cooperate with follow-up
Exclusion Criteria
- •Bilateral breast cancer or ductal/lobular carcinoma in situ (DCIS/LCIS)
- •Received treatment for advanced disease
- •Metastasis at any site
- •Any tumor > T4a (with skin involvement, fixation, inflammatory breast cancer)
- •Clinically or radiologically suspected malignancy in the contralateral breast not confirmed and requiring biopsy
- •Received neoadjuvant therapy, including chemotherapy, radiotherapy, and endocrine therapy
- •History of malignant tumors within the past 5 years (excluding basal cell carcinoma of the skin and cervical carcinoma in situ), including contralateral breast cancer
- •Patient has been enrolled in other clinical trials
- •Patient has severe systemic diseases and/or uncontrolled infections that prevent participation in the study
- •Severe cardiovascular or cerebrovascular diseases within 6 months prior to randomization (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90 mmHg, myocardial infarction, or stroke)
- •Known allergy to relevant medications
- •Women of childbearing age who refuse contraception during treatment and for 8 weeks after treatment completion
- •Pregnant or breastfeeding women
- •Positive pregnancy test before drug administration after joining the trial
- •Individuals with mental illness or cognitive impairment who cannot understand the trial protocol and its side effects, unable to comply with the protocol and follow-up (systematic assessment required prior to enrollment)
- •Individuals without personal freedom and independent civil capacity
Arms & Interventions
standard endocrine therapy
Active Comparator
standard endocrine therapy
Intervention: endocrine therapy (Drug)
standard endocrine therapy plus dalpicilib
Experimental
standard endocrine therapy plus dalpicilib
Intervention: Dalpicilib (Drug)
standard endocrine therapy plus dalpicilib
Experimental
standard endocrine therapy plus dalpicilib
Intervention: endocrine therapy (Drug)
Outcomes
Primary Outcomes
Invasive Disease Free Survival
Time Frame: From enrollment to 3 years post-treatment
Invasive Disease Free Survival
Secondary Outcomes
- 3-Year Disease-Free Survival(From enrollment to 3 years post-treatment)
- Overall Survival(From enrollment to 3 years post-treatment)
- safety(From enrollment to 3 years post-treatment)
- Patient reported outcomes(From enrollment to 3 years post-treatment)
Investigators
Zhimin Shao
Professor
Fudan University
Study Sites (1)
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