Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

NCT ID: NCT01990352

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-05
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pegylated liposomal doxorubicin

The enrolled patients will be treated with pegylated liposomal doxorubicin at 30mg/m2 every 21 days.

Group Type: EXPERIMENTAL

Pegylated liposomal doxorubicin

Intervention Type: DRUG

Doxil will be administered intravenously at 30mg/m2 on days 1 of a 21 day cycle.

Interventions

Pegylated liposomal doxorubicin

Doxil will be administered intravenously at 30mg/m2 on days 1 of a 21 day cycle.

Intervention Type: DRUG

Other Intervention Names

Doxil

Eligibility Criteria

Inclusion Criteria

• Metastatic breast cancer and have formalin-fixed, paraffin embedded primary tumor available for testing BRCA1 protein expression
• Adults over 18 years of age
• Have resolution of all acute toxic effects of any prior chemotherapy or radiotherapy to NCI CTC grade ≤ 1 prior to study registration.
• Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
• Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory and oncological tests and other study procedures
• Have a ECOG performance status of 0 - 2
• Measurable disease by CT by RECIST 1.1 to evaluate response
• Adequate bone marrow function defined as platelets 100 X 109 cells/L, neutrophils 1.5 x 109 cells/L, white blood cells (WBC) 3.0 x 109 cells/L and a hemoglobin 90 gm/L
• Creatinine < 1.5 mg/dl or creatinine clearance > 40 ml/min
• Liver function tests (AST and or ALT) should be 2 x upper limit of normal (ULN, defined as per laboratory where blood testing is done), total bilirubin 1.5 x ULN (except for patients with liver metastases, ALT and/or ALT 5 times the upper limit of normal is accepted)

Exclusion Criteria

• Myocardial infarction within 6 months of registration
• Brain metastases unless documented to be controlled post completion of local therapy (surgery and/or radiation therapy) for at least four weeks prior to registration
• Pregnant or breast feeding women. Women with child bearing potential must use effective measures to prevent pregnancy while receiving pegylated liposomal doxorubicin
• Have a concurrent active non-breast malignancy except for non-melanoma skin cancer
• Her2 positive tumors as defined by FDA guidelines(3+ immunohistochemical staining, defined as uniform, intense membrane staining of more than 10% of invasive tumor cells, and for cases with 2+ staining showing gene amplification by FISH, expressed as a ratio of more than 2 when comparing HER-2 gene and chromosome 17 fluorescent signals)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavani Chalisani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona Cancer Center

Tucson, Arizona, United States

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1300000710

Identifier Type: -

Identifier Source: org_study_id