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Research & Trial Information

Schema B-55

Protocol#: NSABP-B-55

Cancer Type: Breast Adjuvant

Inclusion criteria
1. Female or male patients must be ≥18 years of age.

2. For patients who underwent initial surgery and received adjuvant chemotherapy.

  • TNBC patients must have been axillary node-positive (≥pN1, any tumour size) or axillary node negative (pN0) with invasive primary tumour pathological size > 2 cm (≥pT2).
  • ER and/or PgR positive/HER 2 negative patients must have had ≥ 4 pathologically confirmed positive lymph nodes.


Research & Trial Information

Schema S1207

Protocol#: SWOG – S1207 –   NSABP – B-53

Cancer Type: Breast Adjuvant

Eligibility:

ELIGIBILITY CRITERIA

1. Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2, for whom standard adjuvant endocrine therapy is planned. Estrogen and progesterone receptor positivity must be assessed according to ASCO/CAP guidelines as either ER or PR ≥ 1% positive nuclear staining. HER-2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both. HER-2 is negative if a single test (or all tests) performed in a tumor specimen show: a) IHC negative (0 or 1+) or b) ISH negative using single probe or dual probe (average HER-2 copy number < 4.0 signals per cell by single probe or HER-2/CEP ratio < 2.0 with an average copy number < 4.0 signals per cell by dual probe). If HER-2 IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+. HER-2 equivocal is not eligible.


Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Genesys Health System
Hurley Medical Center
Michigan Cancer Consortium

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