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

Fudan University1 site in 1 country1,388 target enrollmentSeptember 1, 2024

ConditionsBreast Cancer

Interventionsendocrine therapy Dalpicilib

DrugsDalpicilib endocrine therapy

Overview

Phase: Phase 3
Intervention: endocrine therapy
Conditions: Breast Cancer
Sponsor: Fudan University
Enrollment: 1388
Locations: 1
Primary Endpoint: Invasive Disease Free Survival
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2024

End Date

September 30, 2030

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Zhimin Shao

Professor

Fudan University

Eligibility Criteria

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

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)