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

NCT06637150 | Active Not Recruiting Phase 3

• 1 other identifier: SCHBCC-N081
• Study Type: interventional
• Target: 1,388
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Invasive Disease Free Survival

  Invasive Disease Free Survival

  From enrollment to 3 years post-treatment

Secondary Outcomes (4)

• 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

Study Arms (2)

standard endocrine therapy

ACTIVE COMPARATOR

standard endocrine therapy

Drug: endocrine therapy

standard endocrine therapy plus dalpicilib

EXPERIMENTAL

standard endocrine therapy plus dalpicilib

Drug: Dalpicilib; Drug: endocrine therapy

Interventions

Dalpicilib 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.

standard endocrine therapy plus dalpicilib

endocrine therapy DRUG

standard endocrine therapy

standard endocrine therapy; standard endocrine therapy plus dalpicilib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 15, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)