Overview

A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment

Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
Female
Summary
This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Participants will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease progression or unacceptable toxicity occurs.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Docetaxel
Paclitaxel
Taxane
Trastuzumab
Criteria
Inclusion Criteria:

- Female participants , >/= 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

- Participants 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 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