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The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis

NCT05431504 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2022-06-24

No results posted yet for this study

Summary

This is a multicenter, single-arm, open-label, Simon's two-stage exploratory clinical trial. 18 eligible patients with advanced breast cancer with visceral crisis will enroll in stage I. If the study enter stage 2 and continue to include 53 assessable subjects (35 in stage 2). All eligible patients will receive Dalpiciclib plus endocrine therapy chosen by the Physicians until disease progression, death or intolerable toxicity. Tumor assessment was conducted according to RECIST 1.1 criteria.

Conditions

Interventions

DRUG

Dalpiciclib in combination with endocrine therapy by Physicians choice

Dalpiciclib 150 mg orally once daily for 3 weeks, followed by 1 week off in each 4-week cycle. Endocrine therapy including but not limited to fulvestran, tanastrozole, letrozole or exemestane In regular doses

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Fei Ma · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2025-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05431504 on ClinicalTrials.gov