Clinical Trials /

Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

NCT01990352

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 1300000710
  • NCT ID: NCT01990352

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Pegylated liposomal doxorubicinPegylated liposomal doxorubicin

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Pegylated liposomal doxorubicinExperimental
  • Pegylated liposomal doxorubicin

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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate for metastatic breast cancer patients with low BRCA1 protein expression in their tumor, treated with pegylated liposomal doxorubicin
Time Frame:Start of treatment and repeat imaging done at 9 weeks (± 7 days)
Safety Issue:
Description:Evaluating 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. Response rate is defined as the percentage of evaluable patients who achieve complete response (CR) or partial response (PR) as measured by RECIST 1.1 on CT or PET/CT as the best overall response.

Secondary Outcome Measures

Measure:Progression free survival for patients with breast cancer with low BCRCA1 protein expression treated with pegylated liposomal doxorubicin
Time Frame:Start of Treatment until the date of first documented progression or date of death, assessed up to an expected average of 100 weeks
Safety Issue:
Description:Evaluating 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. Progression free survival will be measured as the times from the start of pegylated liposomal doxorubicin to the time the patient is first recorded as having disease progression or dies. If a patient does not progress or die while being followed via tumor assessment, progression-free survival will be censored at the time of last disease assessment. The median progression free survival will be calculated in patients with low BRCA1 protein expression and intact BRCA1 protein expression. Median progression free survival will be estimated by Kaplan-Meier methodology

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:University of Arizona

Last Updated

January 10, 2018