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
NCT04334330 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2022-05-02
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.
Conditions
Interventions
- DRUG
-
Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant
ER/PR positive, HER2-positive breast cancer patients with brain metastatic lesions receive palbociclib PO daily on days 1-21, combined with trastuzumab IV every three weeks, pyrotinib PO daily and fulvestrant IM every 4 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-04
- Primary Completion
- 2023-12-30
- Completion
- 2024-12-31
Countries
- China
Study Locations
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