Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT01990352

Run by

University of Arizona

People needed

24

Starts

2013-11-05

Expected to finish

2022-12-31

Last updated by the study team

2023-11-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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