Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China

Phase 2

Recruiting

• Conditions: Brain Metastases; Breast Cancer
• Interventions: Drug: Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant

• Registration Number: NCT04334330
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The objective of this study is to evaluate the efficacy of combination of palbociclib, trastuzumab and pyrotinib with fulvestrant in ER/PR positive and HER2-positive breast cancer patients with brain metastasis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-06
• Study Start: 2020-12-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-24
• Last Update Posted: 2022-05-02
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant	-

Primary Outcome Measures

Name	Time	Method
Objective response rate in the CNS	Up to 3 years	Assess the response rate in the CNS by MRI according to modified Response Assessment in modified RECIST 1.1 criteria. Objective CNS response is defined as at least 30% decrease in the sum of diameters of CNS target lesions in the absence of new lesions (defined as ≥ 6 mm), increased steroid use, progressive neurological symptoms, and progressive extra-CNS disease as assessed by RECIST 1.1. Confirmatory scans are not required.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 3 years	Evaluate systemic ORR defined as partial response or complete response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time to CNS progression	Up to 3 years	Time to CNS progression will be defined as the time from treatment initiation to documented disease progression (modified RECIST 1.1 criteria) in the CNS
Overall Survival	Up to 3 years	OS is defined as the time from treatment initiation until death due to any cause
Progression Free Survival	Up to 3 years	PFS is defined as the time from treatment initiation to documented disease progression
Time to radiotherapy	Up to 3 years	Time to radiotherapy is defined as the time from the date of inclusion to the date of event defined as the initiation of radiotherapy

Trial Locations

Locations (2)

State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Shusen Wang; 🇨🇳 Guangzhou, Guangdong, China