A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Chugai Pharmaceutical
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmed diagnosis of HER2-positive breast cancer, and hormonal and PD-L1 status, as documented through central testing of a representative tumor tissue specimen
Primary breast tumor size of \> 2 cm by any radiographic measurement
Stage at presentation: T2-T4, N1-N3, M0 as determined by AJCC staging system, 8th edition
Pathologic confirmation of nodal involvement with malignancy must be determined by fine needle aspiration or core-needle biopsy. Surgical excision of lymph nodes is not permitted.
Patients with multifocal tumors are eligible provided at least one focus is sampled and centrally confirmed as HER2-positive.
Patients with multicentric tumors are eligible provided all discrete lesions are sampled and centrally confirmed as HER2-positive.
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Baseline LVEF \>= 55% measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans
Adequate hematologic and end-organ function obtained within 14 days prior to initiation of study treatment
For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
You may not be if
Prior history of invasive breast cancer
Stage IV (metastatic) breast cancer
Patients with synchronous bilateral invasive breast cancer
Prior systemic therapy for treatment of breast cancer
Previous therapy with anthracyclines or taxanes for any malignancy
Sentinel lymph node procedure or axillary lymph node dissection prior to initiation of neoadjuvant therapy
History of other malignancy within 5 years prior to screening, with the exception of those patients who have a negligible risk of metastasis or death
Cardiopulmonary dysfunction
Dyspnea at rest
Active or history of autoimmune disease or immune deficiency
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab/placebo, 6 months after the final dose of doxorubicin, 12 months after the final dose of cyclophosphamide, 6 months after the final dose of paclitaxel, or 7 months after the final dose of trastuzumab, pertuzumab, or trastuzumab emtansine whichever occurs last
Patients who achieved pCR
Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery
Unable to complete surgery with curative intent after conclusion of neoadjuvant systemic therapy
Patient discontinued treatment with trastuzumab because of toxicity during the neoadjuvant phase of the study
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, autoimmune hepatic disorders, or sclerosis cholangitis
Patients with Grade \>=2 peripheral neuropathy
Prior treatment with trastuzumab emtansine
Clareo Health | A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
