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Active Not Recruiting
NCT02326974
T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
Conditions: HER-2 Positive Breast Cancer, Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 164
Sponsor: Dana-Farber Cancer Institute
Location: Massachusetts General Hospital Boston Massachusetts
Summary
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
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT02326974). StuddyBuddy aggregates publicly available trial information.