This research study is studying a combination of drugs as a possible treatment for breast cancer that has tested positive for a protein called HER2.
The names of the study interventions involved in this study are:
* Trastuzumab emtansine (also called T-DM1)
* Pertuzumab
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have HER2-positive Stage II or III histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 2 cm determined by physical exam or imaging is required.
* HER-2 positive, confirmed by central testing (Clarient labs): IHC 3+ and/or FISH positive based on one of the three following criteria:
* Single-probe average HER2 copy number≥6.0 signals/cell OR
* Dual-probe HER2/CEP17 \<2.0 with an average HER2 copy number ≥6.0 signals/cell OR
* Dual-probe HER2/CEP17 ratio ≥2.0
* ER/PR determination is required.
* Bilateral breast cancers are allowed if both cancers are HER2-positive.
* Patients with multifocal or multicentric disease are eligible as long as one area meets eligibility criteria.
* Breast imaging should include the ipsilateral axilla. For subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either before or after preoperative therapy at the discretion of the subject's physicians. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to determine the presence of metastatic disease in the lymph nodes.
* Men and women (with any menopausal status) ≥ 18 years of age
* ECOG performance status 0 or 1
* Required laboratory values:
* ANC ≥1500/mm3
* Hemoglobin ≥ 9 g/dl
* Platelets ≥100,000/mm3
* Serum creatinine \< 1.5 X ULN (institutional)
* Total bilirubin ≤ 1.0 X ULN (institutional) For patients with Gilbert synd…
What they're measuring
1
Rate of Pathologic Complete Response (pCR) by HER2 Amplification Status Non-Heterogeneous
Timeframe: Evaluate upon completion of breast surgery, up to approximately 24 weeks from study enrollment.