NCT01990352

Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

A Single Arm Phase II Trial to Assess Association of BRCA1 Protein Expression With Overall Response Rate in Patients With Metastatic Breast Cancer on Pegylated Liposomal Doxorubicin

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on response when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls Secondary Objective: To evaluate if low BRCA1 protein expression has a preferential effect on tumor progression when metastatic breast cancer patients are treated with DNA damaging chemotherapy agent, compared to historical controls

Detailed description

DNA is constantly subject to damage from exposures including drugs (including chemotherapy), sunlight and aging. Certain genes in the human body help repair this damage (i.e. BRCA1 and other genes). The purpose of this study is to find out if BRCA1 protein expression has a role in response to chemotherapy drugs.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pegylated liposomal doxorubicin	Doxil will be administered intravenously at 30mg/m2 on days 1 of a 21 day cycle.

Timeline

• Start date: 2013-11-05
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2013-11-21
• Last updated: 2023-11-21
• Results posted: 2023-10-26

Locations

2 sites across 1 country: United States