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
| Parameter | Options |
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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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Cancer Center @ Suffolk | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau | 11553 | Uniondale | New York |
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