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Correlate BRCA1 Protein Expression With Response to DNA Damaging Chemotherapy

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ClinicalTrials.gov Identifier: NCT01990352
Recruitment Status : Active, not recruiting
First Posted : November 21, 2013
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Study Description
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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


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pegylated liposomal doxorubicin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 5, 2013
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pegylated liposomal doxorubicin Drug: Pegylated liposomal doxorubicin


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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 :
  1. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990352


Locations
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United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85742
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Pavani Chalisani, MD University of Arizona
More Information
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01990352    
Other Study ID Numbers: 1300000710
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Liposomal doxorubicin
 Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action