A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00444587
First received: March 7, 2007
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This 2 arm study will compare the efficacy and safety of continuation or discont inuation of Herceptin treatment in combination with 2nd line chemotherapy, in pa tients with HER2 positive metastatic breast cancer whose condition has progresse d on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (6mg/kg iv infusion every 3 weeks) while receiving second-line chemotherapy of the investigator's choice. The antic ipated time on study treatment is until disease progression, and the target samp le size is 100-500 individuals.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab [Herceptin]
Drug: Second line 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, Open-label Study to Compare Time to Disease Progression in Patients With HER2 Positive Metastatic Breast Cancer Who Continue or Discontinue Herceptin in Combination With 2nd Line Chemotherapy, Having Progressed on 1st Line Chemotherapy in Combination With Herceptin.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to disease progression [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate, clinical benefit, time to treatment failure, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, LVEF. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 114
Study Start Date: March 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: trastuzumab [Herceptin]
6mg/kg iv every 3 weeks
Drug: Second line chemotherapy
As prescribed
Active Comparator: 2 Drug: Second line chemotherapy
As prescribed

  Eligibility

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

Inclusion Criteria:

  • female patients, >= 18 years of age;
  • metastatic breast cancer;
  • HER2 overexpression (IHC 3+ and/or FISH positive);
  • disease progression during or after previous 1st line chemotherapy + Herceptin;
  • scheduled to receive 2nd line chemotherapy.

Exclusion Criteria:

  • concurrent immunotherapy or hormonal therapy;
  • anthracyclines as part of previous 1st line chemotherapy or planned 2nd line chemotherapy;
  • cardiac toxicity during previous 1st line chemotherapy + Herceptin;
  • history of other malignancy within last 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444587

  Show 43 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: NCT00444587     History of Changes
Other Study ID Numbers: ML19944
Study First Received: March 7, 2007
Last Updated: July 21, 2014
Health Authority: Hungary: National Institute of Pharmacology

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 July 24, 2014