Breast Cancer Foundation NZ
Astefania
Advanced Breast Cancer clinical trials for HER2+
Pending
Updated: January 20, 2022
This study evaluates the efficacy and safety of adjuvant atezolizumab or placebo and trastuzumab emtansine for HER2-positive breast cancer at high risk of recurrence following preoperative therapy
This study evaluates the efficacy and safety of adjuvant atezolizumab or placebo and trastuzumab emtansine for HER2-positive breast cancer at high risk of recurrence following preoperative therapy
Key Inclusion Criteria:
- Histologically confirmed invasive breast carcinoma
- Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
- Centrally confirmed PD-L1 and hormone receptor status
- Clinical stage at disease presentation: cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)
- Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)
- <=12 weeks between primary surgery and randomization
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55%
- Life expectancy >= 6 months
- Adequate hematologic and end organ function
Key Exclusion Criteria:
- Stage IV breast cancer
- An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
- Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
- History of exposure to various cumulative doses of anthracyclines
- History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)
- Current grade >=2 peripheral neuropathy
- History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
- History of or active autoimmune disease or immune deficiency
- Treatment with immunostimulatory or immunosuppressive agents
- Cardiopulmonary dysfunction
- Any known active liver disease
New Zealand
Auckland, Tauranga
Australia
ACT, NSW, NT, QLD, SA, TAS, WA, VIC
If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.
Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz
Similar clinical trials
For Advanced Breast Cancer , DCIS
Are we out of date? If you have updated or new information about a trial, we’d be grateful if you’d share it with us – email your update to intouch@bcf.org.nz
Interested in a clinical trial?
Subscribe for updates & stay in the loop with new studies.