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A Multicenter, Single Arm, Open-Label PhIV Study to Investigate the Effect of First-Line Herceptin (Trastuzumab) in Combination With a Taxane in Patients With Metastatic Breast Cancer Who Relapsed After Receiving (Neo)Adjuvant Herceptin for HER2-Positive Early Breast Cancer


Phase 4
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Multicenter, Single Arm, Open-Label PhIV Study to Investigate the Effect of First-Line Herceptin (Trastuzumab) in Combination With a Taxane in Patients With Metastatic Breast Cancer Who Relapsed After Receiving (Neo)Adjuvant Herceptin for HER2-Positive Early Breast Cancer


Inclusion Criteria:



- Female patients, >/= 18 years of age

- Locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular
lymph nodes is regarded as metastatic disease)

- HER2-positive primary disease

- Patients must have received Herceptin in the adjuvant and/or neoadjuvant setting

- Relapsed breast cancer >/= 6 months after discontinuing last drugs of Herceptin
and/or chemotherapy in the adjuvant and/or neoadjuvant setting for HER2-positive
breast cancer

- Measurable disease according to RECIST 1.0

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Maximum cumulative dose of doxorubicin or no prior anthracyclines

- At least 3 weeks after prior surgery or radiotherapy

Exclusion Criteria:

- Pregnant or breastfeeding women

- Previous chemotherapy for metastatic breast cancer (prior endocrine therapy till
progressive disease is allowed)

- Pleural effusions, ascites or bone lesions as only manifestation of disease

- Brain metastases

- Invasive malignancy other than metastatic breast cancer

- Inadequate bone marrow, hepatic or renal function

- Prior treatment with anti-HER therapies other than (neo)adjuvant Herceptin

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival, tumour assessments according to RECIST criteria

Outcome Time Frame:

up to 4 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

China: Food and Drug Administration

Study ID:

ML25288

NCT ID:

NCT01301729

Start Date:

March 2011

Completion Date:

May 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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