Study on Using Biomarkers to Predict Treatment Response in Patients with Recurrent or Metastatic Triple Negative Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT02422498

This clinical trial is investigating whether a biopsy taken before treatment can help predict how well patients with recurrent or metastatic triple negative breast cancer will respond to a combination of cisplatin and radiation therapy.

Patient Parameters

Program Overview

The purpose of this study is to determine if a biopsy taken before starting treatment can help predict how well patients with recurrent or metastatic triple negative breast cancer will respond to a combination of cisplatin and radiation therapy. This could help doctors tailor treatments more effectively for individual patients.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with invasive triple negative breast cancer, confirmed by specific medical tests.
  • Radiation therapy is needed for the cancer that has come back or spread, and is considered standard care.
  • Age 18 or older.
  • The tumor to be treated must be measurable by standard medical criteria.
  • Willing to have a tumor biopsy before starting treatment.
  • Expected to live more than 6 months.
  • In good overall health, with a performance status score between 0 and 2.
  • Any previous chemotherapy is allowed, including treatments with platinum-based drugs.
  • Previous treatments with approved or experimental drugs are allowed, but must be stopped at least 14 days before the study biopsy.
  • Women who can become pregnant must use effective birth control.
  • Able to understand and sign a consent form.
  • Have adequate organ and bone marrow function, as shown by specific blood tests within 14 days before starting the study.

Exclusion Criteria

  • Tumors that cannot be measured by standard criteria, such as very small lesions or certain types of cancer spread.
  • Brain metastases that need radiation, as these cannot be biopsied and may affect life expectancy.
  • Unable to safely obtain a tumor biopsy.
  • Finished chemotherapy less than 7 days before starting the study.
  • Finished previous radiation therapy less than 7 days before starting the study.
  • Expected to live less than 6 months.
  • Have other serious illnesses or medical conditions that could affect participation.
  • Kidney problems that make cisplatin treatment unsafe.
  • Women must not be pregnant or breastfeeding, and must not become pregnant during the study. A negative pregnancy test is required for women who can become pregnant.
  • Have another active cancer, unless it is a non-threatening type or was treated more than 2 years ago and has not returned.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering at Basking Ridge07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen07645MontvaleNew Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk11725CommackNew York
Memorial Sloan Kettering Westchester10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering Nassau11553UniondaleNew York

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