A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
Status: | Completed |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/9/2017 |
Start Date: | July 31, 2010 |
End Date: | September 16, 2016 |
A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of
trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with
pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab
(Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive
progressive or recurrent locally advanced or previously untreated metastatic breast cancer.
Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be
open-label, whereas Arms B and C will be blinded.
trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with
pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab
(Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive
progressive or recurrent locally advanced or previously untreated metastatic breast cancer.
Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be
open-label, whereas Arms B and C will be blinded.
Inclusion Criteria:
- Adult participants >/=18 years of age
- HER2-positive breast cancer
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally
recurrent or metastatic disease, and be a candidate for chemotherapy. Participants
with locally advanced disease must have recurrent or progressive disease, which must
not be amenable to resection with curative intent.
- Participants must have measurable and/or non-measurable disease which must be
evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Adequate organ function as determined by laboratory results
Exclusion Criteria:
- History of prior (or any) chemotherapy for metastatic breast cancer or recurrent
locally advanced disease
- An interval of <6 months from the last dose of vinca-alkaloid or taxane cytotoxic
chemotherapy until the time of metastatic diagnosis
- Hormone therapy <7 days prior to randomization
- Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) <21 days prior to
randomization
- Prior trastuzumab emtansine or pertuzumab therapy
We found this trial at
92
sites
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Suburban Hospital Suburban Hospital is a community-based, not-for-profit hospital serving Montgomery County and the surrounding...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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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...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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1500 Wallace Boulevard
Amarillo, Texas 79106
Amarillo, Texas 79106
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2001 Medical Parkway
Annapolis, Maryland 21401
Annapolis, Maryland 21401
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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30 Prospect Avenue
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
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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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500 University Dr
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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2406 Century Place Southeast
Hickory, North Carolina 28602
Hickory, North Carolina 28602
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1220 Holcombe Boulevard
Houston, Texas 77030
Houston, Texas 77030
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535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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3855 Health Sciences Drive
La Jolla, California 92093
La Jolla, California 92093
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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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4301 West Markham Street
Little Rock, Arkansas 72204
Little Rock, Arkansas 72204
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1475 Northwest 12th Avenue
Miami, Florida 33136
Miami, Florida 33136
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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607 S New Ballas Rd
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
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Metro-Minnesota CCOP The Metro-Minnesota Community Clinical Oncology (MMCCOP) was established in 1979 through an NCI-funded...
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Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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Carle Cancer Center Carle Cancer Center delivers comprehensive care through leading-edge technology and advanced research,...
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