MedTrace Logo

Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

NCT07101159 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-08-03

No results posted yet for this study

Summary

This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.

It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.

The primary endpoint is 3-year invasive disease-free survival (iDFS).

Conditions

  • Early Breast Cancer
  • Adjuvant Therapy
  • Hormone Receptor Positive / HER2-negative Breast Cancer

Interventions

DRUG

Dalpiciclib

Dalpiciclib 100 mg orally, daily on days 1-21 of a 28-day cycle, for 3 years.

DRUG

Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

Standard adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitor), as per physician's choice.

DRUG

Dalpiciclib

Dalpiciclib 125 mg orally, daily on days 1-21 of a 28-day cycle, for 2 years.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2031-12-31
Completion
2031-12-31

More Related Trials

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 NCT07101159 on ClinicalTrials.gov