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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00444587

Purpose

This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed 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 anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Breast Cancer	Drug: trastuzumab [Herceptin] Drug: Second line chemotherapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:	274
Study Start Date:	March 2007
Estimated Study Completion Date:	August 2011

Arms	Assigned Interventions
1: Experimental	Drug: trastuzumab [Herceptin] 6mg/kg iv every 3 weeks Drug: Second line chemotherapy As prescribed
2: Active Comparator	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

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

Contacts

Contact: Please reference Study ID Number: ML19944	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 47 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19944
Study First Received:	March 7, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00444587
Health Authority:	Hungary: National Institute of Pharmacology

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Disease Progression
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009