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)

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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).


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
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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New Haven, CT
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Baltimore, MD
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Kansas City, Missouri 64132
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Kansas City, MO
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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Nashville, Tennessee 37212
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Nashville, TN
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Salvador, BA 41253
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Salvador,
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San Antonio, TX
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