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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01301729
First received: February 9, 2011
Last updated: July 1, 2016
Last verified: July 2016

February 9, 2011
July 1, 2016
March 2011
July 2014   (final data collection date for primary outcome measure)
Progression-free survival, tumour assessments according to RECIST 1.0 [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
Progression-free survival, tumour assessments according to RECIST criteria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01301729 on ClinicalTrials.gov Archive Site
  • Overall response rate (complete or partial response), tumour assessments according to RECIST 1.0 [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Duration of response: Time from objective response to disease progression [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Exploratory: Determination of biomarkers indicative for response (serum and tumour tissue analyses) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate (defined as complete response or partial response or stable disease for at least 6 months) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Overall response rate (Complete and partial response), tumour assessments according RECIST criteria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Duration of response: Time from objective response to disease progression [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Determination of biomarkers indicative for response (serum and tumour tissue analyses) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Patients With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
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
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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: docetaxel
    100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks)
  • Drug: paclitaxel
    90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks)
  • Drug: trastuzumab [Herceptin]
    4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
Experimental: Single Arm
Interventions:
  • Drug: docetaxel
  • Drug: paclitaxel
  • Drug: trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01301729
ML25288
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP