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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

Dalpiciclib in combination with endocrine therapy by Physicians choice

Fei Ma

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.

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

An Exploratory Trial of Dalpiciclib in Combination With Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis

6-month-Overall Survival rate. Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death.

Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death.

The OS will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.

1-year-Overall Survival rate. Overall Survival , defined as the time from the start of treatment to the date of death, regardless of the cause of death.

Progression-Free Survival is defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.

The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.

TTF is defined as date of treatment start until permanent treatment discontinuation due to progressive disease or unacceptable toxicity.

The TTF will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median TTF, hazard ratio with appropriate confidence intervals will be reported.

ORR is defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death.

The ORR will be reported by percentage with each arms and appropriate confidence intervals.

CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. PR or CR or SD is according to RECIST version 1.1.

The CBR will be reported by percentage with each arms and appropriate confidence intervals.

DoR is defined as date of initial confirmed PR/CR until date of progressive disease or death from any cause. PR or CR or SD is according to RECIST version 1.1.

The DoR will be estimated using Kaplan-Meier method. Kaplan-Meier curves, median DoR, hazard ratio with appropriate confidence intervals will be reported.

TTR, defined as the time from the date of randomization to the date of first CR or PR. CR or PR is according to RECIST version 1.1.

The TTR will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median TTR, hazard ratio with appropriate confidence intervals will be reported.

AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

The type, grade and frequency of AEs will be reported.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis	NCT05431504	Advanced Breast...	Dalpiciclib in ...	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis	NCT05431504	Advanced Breast...	Dalpiciclib in ...	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
The Efficacy and Safety of Dalpiciclib Plus Endocrine Therapy in HR-positive / HER2-negative Advanced Breast Cancer Patients With Visceral Crisis	NCT05431504	Advanced Breast...	Dalpiciclib in ...	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for dalpiciclib in combination with endocrine therapy by physicians choice