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A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer (MARIANNE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01120184
First received: April 28, 2010
Last updated: November 24, 2014
Last verified: November 2014

April 28, 2010
November 24, 2014
July 2010
February 2016   (final data collection date for primary outcome measure)
  • Progression Free Survival (PFS) based on tumor assessments performed by an Independent Review Facility (IRF) [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to approximately 78 months after study start ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) based on tumor assessments reviewed by an Independent Review Facility (IRF) [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to approximately 78 months after study start ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01120184 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) truncated at 2 years [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • 1-year survival rate [ Time Frame: From baseline to 1 year ] [ Designated as safety issue: No ]
  • Overall Survival (OS) rate [ Time Frame: Up to approximately 78 months after study start ] [ Designated as safety issue: No ]
  • Overall or objective response rate [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • Time-to-Treatment Failure as assessed by IRF [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • 1-year survival rate [ Time Frame: From baseline to 1 year ] [ Designated as safety issue: No ]
  • Overall Survival (OS) rate [ Time Frame: Up to approximately 78 months after study start ] [ Designated as safety issue: No ]
  • Time-to-Treatment Failure as assessed by IRF [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • Overall or objective response rate [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • Clinical benefit rate [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to approximately 48 months after study start ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer (MARIANNE)
A Study of Trastuzumab-DM1 Plus Pertuzumab Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer

This randomized, 3-arm, multicentre, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtan sine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combin ation of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in patien ts with HER2-positive progressive or recurrent locally advanced or previously un treated metastatic breast cancer. Patients will be randomized to 1 of 3 treatmen t arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Breast Cancer
  • Drug: docetaxel
    75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.
  • Drug: paclitaxel
    80 mg/m2 intravenously weekly for a minimum of 18 weeks
  • Drug: pertuzumab
    840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
  • Drug: pertuzumab-placebo
    840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
  • Drug: trastuzumab [Herceptin]
    trastuzumab [Herceptin] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1.
  • Drug: trastuzumab emtansine
    3.6 mg/kg intravenously every 3 weeks
  • Experimental: Trastuzumab + Taxane (docetaxel or paclitaxel)
    Interventions:
    • Drug: docetaxel
    • Drug: paclitaxel
    • Drug: trastuzumab [Herceptin]
  • Experimental: Trastuzumab emtansine + pertuzumab
    Interventions:
    • Drug: pertuzumab
    • Drug: pertuzumab-placebo
    • Drug: trastuzumab emtansine
  • Experimental: Trastuzumab emtansine + pertuzumab placebo
    Interventions:
    • Drug: pertuzumab
    • Drug: pertuzumab-placebo
    • Drug: trastuzumab emtansine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1095
February 2016
February 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients >/=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. Patients with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
  • Patients must have measurable and/or non-measurable disease which must be evaluable per RECIST 1.1
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Bahamas,   Belgium,   Bosnia and Herzegovina,   Brazil,   Canada,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Guatemala,   Hungary,   Italy,   Japan,   Korea, Republic of,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Mexico,   New Zealand,   Panama,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT01120184
BO22589
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Genentech, Inc.
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP