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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444587
• Other study ID #: ML19944
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2007
• Last updated: December 1, 2015
• Start date: March 2007
• Est. completion date: August 2011

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacology
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Second line chemotherapy
As prescribed
• trastuzumab [Herceptin]
6mg/kg iv every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Bulgaria,  Estonia,  Hungary,  Israel,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Romania,  Slovakia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to disease progression		Event driven	No
Secondary	Objective response rate, clinical benefit, time to treatment failure, overall survival.		Event driven	No
Secondary	AEs, laboratory parameters, LVEF.		Throughout study	No