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.
Verified April 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: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: pertuzumab
Drug: trastuzumab
Drug: Aromatase Inhibitor
Drug: Induction Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Up to approximately 33 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 250
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
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.
Active Comparator: 2 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491737

Contacts
Contact: Reference Study ID Number: MO27775 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 93 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01491737     History of Changes
Other Study ID Numbers: MO27775
Study First Received: December 6, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014