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A Study of Perjeta (Pertuzumab) in Combination With Herceptin in Patients With Metastatic Breast Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01674062
First received: August 24, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin in patients with metastatic breast cancer who have progressed on Herceptin-based therapy, and will make a preliminary assessment of the efficacy and safety of single agent pertuzumab. Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840mg intravenously (iv) on day 1, followed by 420mg iv every 3 weeks. Herceptin will be administered at the same schedule the patient was following before entry into the study. An additional cohort of patients, at certain centers, will receive pertuzumab monotherapy, at an initial dose of 840mg iv on day 1, followed by 420mg iv every 3 weeks. The anticipated time on study treatment is until disease progression.


Condition Intervention Phase
Breast Cancer
 Drug: pertuzumab [Perjeta]
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Single-arm Study to Evaluate the Effect of Pertuzumab in Combination With Herceptin on Response Rate in Patients With HER2-positive Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Objective response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical benefit response according to Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to response [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: Approximately 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: May 2006
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab Arm Drug: pertuzumab [Perjeta]
Loading dose 840 mg intravenously on Day 2 of the first cycle. 420 mg every 3 weeks thereafter, until disease progression or unacceptable toxicity.

  Eligibility

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

Inclusion Criteria:

  • Adult patients, >=18 years of age, with histologically-confirmed HER2-positive breast cancer
  • Metastatic breast cancer, with progression on Herceptin-based therapy as last treatment for metastatic disease
  • <=3 chemotherapy regimens prior to study entry
  • Last Herceptin dose <=9 weeks before study entry for patients reciving pertuzumab + Herceptin, and >=4 weeks for patients receiving pertuzumab monotherapy
  • LVEF>= 55% at study entry

Exclusion Criteria:

  • Previous treatment with an anti-cancer vaccine or any targeted therapy other than Herceptin
  • Brain metastases
  • History of any cardiac AE related to Herceptin therapy
  • Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674062

Locations
Canada, Alberta
Edmonton, Alberta, Canada, T5J 3N4
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
London, Ontario, Canada, N6A 4L6
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M4N 3M5
France
Besancon, France, 25030
Dijon, France, 21079
Lille, France, 59020
Montpellier, France, 34298
Italy
Milano, Italy, 20133
Modena, Italy, 41100
Parma, Italy, 43100
Spain
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Valencia, Spain, 46009
Valencia, Spain, 46010
United Kingdom
Edinburgh, United Kingdom, EH4 2XU
Manchester, United Kingdom, M20 4BX
Northwood, United Kingdom, HA6 2RN
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01674062     History of Changes
Other Study ID Numbers: BO17929, 2005-003493-19
Study First Received: August 24, 2012
Last Updated: May 7, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013