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

NCT ID: NCT06637150

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1388 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2030-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard endocrine therapy

standard endocrine therapy

Group Type: ACTIVE_COMPARATOR

endocrine therapy

Intervention Type: DRUG

standard endocrine therapy

standard endocrine therapy plus dalpicilib

standard endocrine therapy plus dalpicilib

Group Type: EXPERIMENTAL

Dalpicilib

Intervention Type: DRUG

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.

endocrine therapy

Intervention Type: DRUG

standard endocrine therapy

Interventions

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.

Intervention Type: DRUG

endocrine therapy

standard endocrine therapy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

breast cancer institute of Fudan University Cancer Hospital, shanghai, shanghai

Shanghai, , China

Countries

China

Other Identifiers

SCHBCC-N081

Identifier Type: -

Identifier Source: org_study_id