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A Randomized, Open-label Study to Compare Progression-free Survival 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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomized, Open-label Study to Compare Progression-free Survival 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


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 plus Herceptin;

- scheduled to receive 2nd line chemotherapy.

Exclusion Criteria:

- incompatibility with previous Herceptin therapy;

- pregnancy.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Italy: Ministry of Health

Study ID:

ML18742

NCT ID:

NCT00448279

Start Date:

November 2006

Completion Date:

November 2011

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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