Dalpicilib-Enhanced Vs. Standard Endocrine Therapy in ER+ HER2- Early Breast Cancer

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

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 Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: endocrine therapy; Drug: Dalpicilib

• Study Type: Interventional
• Enrollment (Estimated): 1388
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • breast cancer institute of Fudan University Cancer Hospital, shanghai, shanghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women aged 18-70 years
2. ECOG score of 0-1
3. Histologically confirmed unilateral invasive cancer (regardless of pathology type)
4. No macroscopic or microscopic tumor residue after surgical resection
5. 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)
6. 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
7. No prior neoadjuvant treatment
8. Time from surgery or completion of chemotherapy or radiotherapy (whichever occurs later) to randomization does not exceed 8 weeks
9. Good postoperative recovery, at least 1 week after surgery
10. 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
11. Women of childbearing age must use contraception during treatment
12. Subjects voluntarily join this study, sign informed consent, demonstrate good compliance, and cooperate with follow-up

Exclusion Criteria:

1. Bilateral breast cancer or ductal/lobular carcinoma in situ (DCIS/LCIS)
2. Received treatment for advanced disease
3. Metastasis at any site
4. Any tumor > T4a (with skin involvement, fixation, inflammatory breast cancer)
5. Clinically or radiologically suspected malignancy in the contralateral breast not confirmed and requiring biopsy
6. Received neoadjuvant therapy, including chemotherapy, radiotherapy, and endocrine therapy
7. 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
8. Patient has been enrolled in other clinical trials
9. Patient has severe systemic diseases and/or uncontrolled infections that prevent participation in the study
10. 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)
11. Known allergy to relevant medications
12. Women of childbearing age who refuse contraception during treatment and for 8 weeks after treatment completion
13. Pregnant or breastfeeding women
14. Positive pregnancy test before drug administration after joining the trial
15. 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)
16. Individuals without personal freedom and independent civil capacity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard endocrine therapy	Drug: endocrine therapy; standard endocrine therapy
Experimental: standard endocrine therapy plus dalpicilib	Drug: endocrine therapy; standard endocrine therapy; Drug: Dalpicilib; Dalpicilib 100 mg once daily from day 1 to day 21, every 4 weeks, for a total of 3 years, in combination with endocrine therapy for 5 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease Free Survival	Invasive Disease Free Survival	From enrollment to 3 years post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-Year Disease-Free Survival		From enrollment to 3 years post-treatment
Overall Survival	Overall Survival	From enrollment to 3 years post-treatment
safety	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	From enrollment to 3 years post-treatment
Patient reported outcomes	Patient-Reported Outcomes (PROs) Assessed by the EORTC QLQ-C30 Questionnaire. Provide a brief description of what aspects of the patient's health or experience the tool will measure (e.g., quality of life, symptom burden, treatment side effects).	From enrollment to 3 years post-treatment

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: September 28, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SCHBCC-N081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No