T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA (NCT02326974)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (30 items) and avoid the listed exclusions (9 items).
Location: Massachusetts General Hospital — Boston, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Pregnant or nursing women due to the teratogenic potential of the study drugs.
- Active, unresolved infection.
- Receipt of intravenous antibiotics for infection within 7 days prior to enrollment.
- Patients with active liver disease, for example, due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis.
- Uncontrolled hypertension (systolic \>180 mm Hg and/or diastolic \>100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher, or serious cardiac arrhythmia requiring medication.
- Significant symptoms (Grade ≥2) peripheral neuropathy.
- Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes.
- Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- Massachusetts General Hospital — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Tennessee Oncology/Sarah Cannon Research Institute — Nashville, Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.