Research & Trial Information
Protocol#: NRG – BR003
Cancer Type: Breast Adjuvant
Eligibility Criteria
1. The trial is open to female and male patients.
2. Age ≥ 18 years.
Research & Trial Information
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
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.