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Trial record 1 of 1 for:    NCT01491737
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A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Patients With Hormone Receptor-Positive, Metastatic HER2-positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01491737
First received: December 6, 2011
Last updated: November 1, 2016
Last verified: November 2016

December 6, 2011
November 1, 2016
February 2012
October 2019   (Final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: Up to approximately 33 months ]
Progression-free Survival [ Time Frame: Up to approximately 49 months ]
Complete list of historical versions of study NCT01491737 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Up to approximately 49 months ]
  • Overall Response Rate [ Time Frame: Up to approximately 49 months ]
  • Clinical Benefit Rate [ Time Frame: Up to approximately 49 months ]
  • Duration of Response [ Time Frame: Up to approximately 49 months ]
  • Time to Response [ Time Frame: Up to approximately 49 months ]
  • Safety: Incidence of Adverse Events [ Time Frame: Up to approximately 49 months ]
  • Quality of Life: EQ-5D Questionnaire [ Time Frame: Up to approximately 49 months ]
Same as current
Not Provided
Not Provided
 
A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Patients With Hormone Receptor-Positive, Metastatic HER2-positive Breast Cancer
A Randomized, Two-arm, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-positive and Hormone Receptor-positive Advanced (Metastatic or Locally Advanced) Breast Cancer.
This randomized, open-label, 2-arm, multi-center, phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab (Herceptin) plus an aromatase inhibitor in first-line patients with HER2-positive and hormone receptor-positive advanced breast cancer. Patients will be randomized to one of two treatment arms: Arm 1: pertuzumab plus trastuzumab plus aromatase inhibitor, Arm 2: trastuzumab plus aromatase inhibitor. At the investigator's discretion, patients may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel). The anticipated time on study treatment is until disease progression or unacceptable toxicity.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Aromatase Inhibitor
    1 mg anastrozole or 2.5 mg letrozole orally once daily
  • Drug: Induction Chemotherapy
    At the investigator's discretion, patients may also receive induction chemotherapy, either docetaxel or paclitaxel.
  • Drug: pertuzumab
    Loading dose of 840 mg intravenously on Day 1 of first treatment cycle, followed by 420 mg on Day 1 of each subsequent 3-weeks cycle. Until disease progression or unacceptable toxicity.
  • Drug: trastuzumab
    Loading dose of 8 mg/kg intravenously on Day 1 of first treatment cycle, followed by 6 mg/kg on Day 1 of each subsequent treatment 3-weeks cycles. Until disease progression or unacceptable toxicity.
  • Experimental: 1
    Interventions:
    • Drug: Aromatase Inhibitor
    • Drug: Induction Chemotherapy
    • Drug: pertuzumab
    • Drug: trastuzumab
  • Active Comparator: 2
    Interventions:
    • Drug: Aromatase Inhibitor
    • Drug: Induction Chemotherapy
    • Drug: trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
October 2019
October 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female adult patients, >/=18 years of age
  • Patients with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
  • Post-menopausal status over 1 year
  • HER2-positive as assessed by local laboratory on primary or metastatic tumor
  • Hormone-receptor positive defined as ER-positive and/or PgR-positive
  • At least one measurable lesion and/or non-measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)

Exclusion Criteria:

  • Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
  • Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
  • Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
  • Other malignancies in </= 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
  • Clinical or radiographic evidence of central nervous system (CNS) metastases or significant CV disease
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact: Reference Study ID Number: MO27775 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com
United States,   Brazil,   France,   India,   Italy,   Spain,   Turkey,   United Kingdom
 
 
NCT01491737
MO27775
Not Provided
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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