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Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study

NCT07581834 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2026-05-12

No results posted yet for this study

Summary

This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III).

Cohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.

Conditions

  • Breast Diseases
  • Breast Neoplasms
  • Dalpiciclib
  • Endocrine Breast Diseases
  • CDK4/6 Inhibitor
  • HR+/HER2- Breast Cancer

Interventions

DRUG

Dalpiciclib 125mg

Dalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 2 years.

DRUG

Dalpiciclib 100mg

Dalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years.

DRUG

Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen

Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-21
Primary Completion
2031-12-31
Completion
2032-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07581834 on ClinicalTrials.gov