Clinical Trials /

Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy

NCT02422498

Description:

The study is being done to find out if the results of a pre-treatment biopsy can predict response to cisplatin and radiation treatment for patients with metastatic or recurrent triple negative breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic <span class="go-doc-concept go-doc-keyword">Triple Negative</span> Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy

Title

  • Brief Title: Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy
  • Official Title: A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy
  • Clinical Trial IDs

    NCT ID: NCT02422498

    ORG ID: 15-032

    Trial Conditions

    Locally Recurrent/Metastatic Triple Negative Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    cisplatin Concurrent Cisplatin & Radiation Therapy

    Trial Purpose

    The study is being done to find out if the results of a pre-treatment biopsy can predict
    response to cisplatin and radiation treatment for patients with metastatic or recurrent
    triple negative breast cancer.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Concurrent Cisplatin & Radiation Therapy Experimental cisplatin

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically-confirmed invasive triple negative breast cancer (ER <1%, PR <1%,
    her-2-neu 0-1+ by IHC or FISH-negative)

    - Radiation to the recurrent or metastatic site is clinically indicated and would be
    considered standard care for palliation or for locoregional control

    - Age 18

    - Tumor to be irradiated is measurable by RECIST 1.1 or PRC (see Appendix 1 and Section
    12.0)

    - Willingness to undergo tumor biopsy prior to initiation of treatment

    - Life expectancy greater than 6 months

    - ECOG performance status 0-2

    - Any prior chemotherapy is allowed including prior treatment with platinum-containing
    chemotherapy

    - Prior treatment with FDA-approved or investigational biologics or novel molecularly
    target therapies, including oral or IV formulations, are permitted.

    - Patients must be off prior targeted therapy for at least 14 days prior to study
    biopsy.

    - Use of an effective means of contraception in women of child-bearing potential

    - Ability to comprehend and sign informed consent

    - Adequate organ and marrow function within 14 days prior to study entry, defined as:

    - Absolute neutrophil count (ANC)>1000/mm3

    - Hemoglobin >9 gm/dl

    - Platelets >100,000/mm3

    - Serum creatinine <1.5 mg/dl OR creatinine clearance of 50 cc/min

    - SGOT/SGPT<2.5X institutional ULN (<5X ULN if known liver metastases)

    Exclusion Criteria:

    - Unmeasurable target tumor site by RECIST 1.1 or PRC (ex: lesions <2 cm on CT or MR
    scan, leptomeningeal disease, ascites, pleural/pericardial effusion, lymphangitis,
    non-FDG-avid skin lesions)

    - Brain metastases requiring focal or whole brain radiation will be excluded, as these
    lesions cannot be biopsied and can have life expectancies <6 months.

    - Inability to obtain a biopsy of the tumor as deemed by the study Interventional
    Radiologist

    - Prior chemotherapy completed <7 days prior to planned study entry

    - Prior RT is allowed and must have been completed more than 7 days before planned
    study entry.

    - Note: For re-irradiation cases, standard departmental guidelines should be
    followed so as to not exceed normal tissue

    - Life expectancy less than 6 months

    - Intercurrent illness or other major medical condition or comorbid condition that
    might affect study participation (uncontrolled renal, pulmonary or hepatic
    dysfunction or infection)

    - Renal dysfunction for which cisplatin dose would be considered unsafe.

    - Women on study must be neither pregnant nor nursing nor expected to become pregnant
    during therapy. For premenopausal women, negative pregnancy test within 14 days of RT
    is required.

    - Concurrent active malignancy other than non-melanomatous skin cancer or carcinoma
    in-situ of the cervix, unless treatment for the previous cancer was completed >2
    years prior to study entry and patient has remained disease-free.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    response (RECIST 1.1 vs. PET Response Criteria (PRC) as measurement tools for treatment response)

    Secondary Outcome Measures

    Trial Keywords

    Treated with Concurrent Cisplatin

    Treated with Radiation Therapy

    Homologous Recombination Repair Status

    Biomarker of Response

    15-032

    Patients