Clinical Trial Protocol Registry

Trial information

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

Protocol number:
Hoffmann-La Roche
Company division:
Product name:
Generic name:
Official Scientific Title:
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
Brief summary:
This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastutumab) in combination with a taxane as first line therapy in patients with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment. Patients 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. Target sample size is 32.
Study phase:
Study type:
Interventional; Treatment; Non-randomized; Open label; Single group; Safety/efficacy study
  • Breast Cancer
Primary outcome:
  1. Progression-free survival, tumour assessments according to RECIST 1.0 Time frame: up to 4 years
Key secondary outcomes:
  1. Overall response rate (complete or partial response), tumour assessments according to RECIST 1.0 Time frame: up to 4 years
  2. Duration of response: Time from objective response to disease progression Time frame: up to 4 years
  3. Overall survival Time frame: up to 4 years
  4. Safety: Incidence of adverse events Time frame: up to 4 years
  5. Exploratory: Determination of biomarkers indicative for response (serum and tumour tissue analyses) Time frame: up to 4 years
  6. Clinical benefit rate (defined as complete response or partial response or stable disease for at least 6 months) Time frame: up to 4 years
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 </= 360 mg/m2 or of epirubicin </= 720 mg/m2 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
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
Anticipated start date:
March, 2011
Trial registration date:
Date last updated:
This trial was conducted at the following locations:
  • Beijing
  • Chengdu
  • Guangzhou
  • Hangzhou
  • Harbin
  • Shanghai
  • Shenyang
  • Wuhan
  • Zhengzhou

Link to trial result

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