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A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patientsd with Residual Triple-Negative Breast Cancer Following Neo-Adjuvant Chemotherapy

October 22, 2019

Research & Trial Information

SCHEMA EA1131

Protocol#: ECOG – EA1131

Cancer Type: Breast Adjuvant Triple Neg. Following Neo-Adjuvant Chemotherapy

Patient Eligibility:

  1. Age ≥ 18 years.
  2. ECOG Performance Status 0 or 1 within 2 weeks prior to screening.
  3. Female and male patients must have histologically confirmed invasive breast cancer.

  4. Clinical stage II or III at diagnosis, based on initial evaluation by clinical examination and/or breast imaging; no metastatic disease allowed.
  5. ER- and PR- and HER2 negative.
  6. Patients must have completed neoadjuvant taxane +/- anthracycline. Patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen.

  7. Must have completed definitive resection of primary tumor.
  8. Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery. Residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination. Please note that in patients that have multifocal or multicentric residual tumors these lesions cannot be added up; the biggest lesion has to measure 1 cm in diameter. This is required due to constraints in DNA extraction for PAM50 analysis.

  9. Radiotherapy may be given before or after protocol treatment per standard of care guidelines. When radiotherapy is planned prior to protocol treatment administration, patients may be registered and screened while receiving radiation.

  10. No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent malignancies of any sort.

  11. No clinically significant infections as judged by the treating investigator.

  12. Patients with active grade 2 neuropathy are ineligible.
  13. Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed. LHRH agonists and adjuvant bisphosphonate or denosumab use is allowed.

  14. Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis for stratification.

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

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