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 October 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01491737
First received: December 6, 2011
Last updated: October 20, 2014
Last verified: October 2014

December 6, 2011
October 20, 2014
February 2012
May 2016   (final data collection date for primary outcome measure)
Progression-free Survival [ Time Frame: Up to approximately 33 months ] [ Designated as safety issue: No ]
Progression-free Survival [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01491737 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of Adverse Events [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Quality of Life: EQ-5D Questionnaire [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
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 t he efficacy and safety of pertuzumab in combination with trastuzumab (Herceptin) plus an aromatase inhibitor in first-line patients with HER2-positive and hormo ne receptor-positive advanced breast cancer. Patients will be randomized to one of two treatment arms: Arm 1: pertuzumab plus trastuzumab plus aromatase inhibit or, Arm 2: trastuzumab plus aromatase inhibitor. At the investigator's discretio n, patients may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel). The anticipated time on study treatment is until disease progres sion or unacceptable toxicity.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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
May 2016
May 2016   (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
Female
18 Years and older
No
Contact: Reference Study ID Number: MO27775 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Italy,   United States,   Brazil,   France,   India,   United Kingdom,   Spain,   Turkey
 
NCT01491737
MO27775
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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