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

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

  • ORG STUDY ID: 15-032
  • NCT ID: NCT02422498

Conditions

  • Locally Recurrent/Metastatic Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
cisplatinConcurrent Cisplatin & Radiation Therapy

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.

Trial Arms

NameTypeDescriptionInterventions
Concurrent Cisplatin & Radiation TherapyExperimental
  • 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) or as determined by MD discretion

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

          -  Age ≥18 years

          -  Tumor to be irradiated is measurable by RECIST 1.1 or PRC

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:response (RECIST 1.1 vs. PET Response Criteria (PRC) as measurement tools for treatment response)
Time Frame:2 years
Safety Issue:
Description:Compare the efficacy of RECIST 1.1 vs. PET Response Criteria (PRC) as measurement tools for treatment response.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Treated with Concurrent Cisplatin
  • Treated with Radiation Therapy
  • Homologous Recombination Repair Status
  • Biomarker of Response
  • 15-032
  • Patients

Last Updated

November 13, 2020