A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/1/2019 |
Start Date: | November 8, 2011 |
End Date: | December 1, 2023 |
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and
efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in
participants with operable HER2-positive primary breast cancer. This study will be carried
out in collaboration with the Breast International Group (BIG).
efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in
participants with operable HER2-positive primary breast cancer. This study will be carried
out in collaboration with the Breast International Group (BIG).
Inclusion Criteria:
- Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is
histologically confirmed, and adequately excised
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
(=) 1
- Known hormone receptor status (estrogen receptor and progesterone receptor)
- The interval between definitive surgery for breast cancer and the first dose of
chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy
must be administered within 7 days of randomization or on Day 56, whichever occurs
first
- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55
percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA)
Scan
- Confirmed HER2 positive status
- Completion of all necessary baseline laboratory and radiologic investigations prior to
randomization
- Women of childbearing potential and male participants with partners of childbearing
potential must agree to use effective contraception (as defined by the protocol) by
the participant and/or partner for the duration of the study treatment and for at
least 7 months after the last dose of study drug
Exclusion Criteria:
- History of any prior (ipsi- and/or contralateral) invasive breast cancer
- History of non-breast malignancies within the 5 years prior to study entry, except for
carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and
basal cell and squamous cell carcinomas of the skin
- Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant
metastasis (TNM), including inflammatory breast cancer
- Any node-negative tumor
- Any previous systemic chemotherapy for cancer or radiotherapy for cancer
- Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy
for cancer
- Concurrent anti-cancer treatment in another investigational trial
- Serious cardiac or cardiovascular disease or condition
- Other concurrent serious diseases that may interfere with planned treatment including
severe pulmonary conditions/illness
- Abnormal laboratory tests immediately prior to randomization
- Pregnant or lactating women
- Sensitivity to any of the study medications or any of the ingredients or excipients of
these medications
We found this trial at
144
sites
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Port Saint Lucie, Florida 34952
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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330 Brookline Avenue
Boston, Massachusetts 02215
Boston, Massachusetts 02215
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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1 Hospital Drive
Columbia, Missouri 65203
Columbia, Missouri 65203
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
Columbus, Ohio 43219
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U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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25 Michigan St. NE, Suite 3100
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
(616) 391-1230
Grand Rapids Clinical Oncology Program GRCOP initially formed to develop community cancer patient management guidelines....
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65 International Drive
Greenville, South Carolina 29615
Greenville, South Carolina 29615
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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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2406 Century Place Southeast
Hickory, North Carolina 28602
Hickory, North Carolina 28602
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
Jacksonville, Florida 32256
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
Marietta, Georgia 30060
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1 Medical Center Drive
Morgantown, West Virginia 26506
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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1448 Common Street
New Braunfels, Texas 78130
New Braunfels, Texas 78130
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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5501 Old York Road
Philadelphia, Pennsylvania 19141
Philadelphia, Pennsylvania 19141
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