At a glance
ClinicalIndex Comparison Record- ✓Age ≥60 years at time of study registration
- ✓Histologically or cytologically confirmed HER2-positive disease (IHC 3+ or FISH HER2/CEP17 ≥2 or ≥6 HER2 gene copies) confirmed by central pathology review
- ✓Stage I–III breast cancer: node-negative tumors >5 mm or node-positive (N1–N3) tumors of any size (T1mi–T3)
- ✓Standard chemotherapy/trastuzumab declined by patient or patient deemed ineligible by physician
- ✕Evidence of metastatic disease
- ✕Locally advanced tumors at diagnosis (T4), including tumors fixed to chest wall, peau d'orange, skin ulcerations/nodules, or inflammatory changes
- ✕Stage III HER2-negative cancer in contralateral breast
- ✕Active hepatitis B or C (with abnormal liver function tests) or active liver disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ATOP TRIAL: Adjuvant Ado-Trastuzumab Emtansine (T-DM1) for Older Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
In Brief
A Phase 2 clinical trial evaluating T-DM1 for Breast Cancer. Active but no longer recruiting, targeting 111 participants across 14 sites.
Detailed Summary
This research study is studying an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)
Study Details
Timeline
Interventions
T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to a cytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because it targets HER2-positive breast cancer cells directly, limiting exposure of the rest of the body to chemotherapy.