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A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

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Trial Information

A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.


Inclusion Criteria:



- adult patients, >=18 years of age;

- HER2 positive breast cancer with locally recurrent or metastatic lesions;

- eligible for chemotherapy;

- baseline LVEF >=50%.

Exclusion Criteria:

- previous chemotherapy for metastatic or locally recurrent breast cancer;

- previous radiotherapy for metastatic breast cancer (except for metastatic bone pain
relief);

- other primary tumor within last 5 years, with the exception of basal or squamous skin
cancer, or in situ cancer of the cervix;

- clinically significant cardiovascular disease;

- chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).

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:

BO20231

NCT ID:

NCT00391092

Start Date:

September 2006

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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