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
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/22/2019 |
Start Date: | January 11, 2019 |
End Date: | February 8, 2023 |
Contact: | Reference Study ID Number: BO40747 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial 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
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab
compared with placebo when given in combination with neoadjuvant dose-dense anthracycline
(doxorubicin + cyclophosphamide) followed by paclitaxel + trastuzumab + pertuzumab
(ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).
compared with placebo when given in combination with neoadjuvant dose-dense anthracycline
(doxorubicin + cyclophosphamide) followed by paclitaxel + trastuzumab + pertuzumab
(ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).
Inclusion Criteria:
- 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 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
fineneedle aspiration or core-needle biopsy. Surgical excision of lymph nodes is not
permitted.
- Patients with multifocal tumors or multicentric tumors are eligible provided all
discrete lesions are sampled and centrally confirmed as HER2-positive.
- Patients with synchronous bilateral invasive disease are eligible so long as both
lesions are 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
Exclusion Criteria:
- Prior history of invasive breast cancer
- Stage IV (metastatic) breast cancer
- Prior systemic therapy for treatment of breast cancer
- Previous therapy with anthracyclines or taxanes for any malignancy
- Ulcerating breast cancer
- Undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph
nodes
- 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 and/or pertuzumab, whichever occurs last
We found this trial at
10
sites
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
Click here to add this to my saved trials
4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
Click here to add this to my saved trials
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
Click here to add this to my saved trials
Click here to add this to my saved trials
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials