Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants 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: November 2, 2016
Last verified: November 2016

February 9, 2011
November 2, 2016
March 2011
July 2014   (Final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: From the date of informed consent to the date of death or progressive disease (up to 28 months) ]
PFS was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.0 and was defined as the time from the date when the participant signed the informed consent form (ICF) until death or progressive disease (PD). PD was defined as 20% increase in the sum of the longest diameter of target lesions. PFS and associated confidence intervals were calculated using the Kaplan-Meier method.
Progression-free survival, tumour assessments according to RECIST criteria [ Time Frame: up to 4 years ]
Complete list of historical versions of study NCT01301729 on ClinicalTrials.gov Archive Site
  • Overall Response Rate [ Time Frame: up to 28 months ]
    Overall response rate was assessed using RECIST 1.0 and defined as the percentage of participants that achieved a complete response (CR) or a partial response (PR). CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions.
  • Duration of Response [ Time Frame: From the time of PR or CR until the date of PD or death (up to 28 months) ]
    Duration of response was defined as the time from when a PR or CR was first documented until the date of documented PD or death. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. PD was defined as 20% increase in the sum of the longest diameter of target lesions.
  • Overall Survival [ Time Frame: Time from enrollment to the date of death (up to 28 months) ]
    Overall survival was defined as the time from the date of enrollment to the date of death due to any cause.
  • Percentage of Participants With an Adverse Event (AE) [ Time Frame: Up to 28 days after last infusion of the study drug (28 months) ]
    An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
  • Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses) [ Time Frame: up to 28 months ]
  • Clinical Benefit Rate [ Time Frame: up to 28 months ]
    Clinical benefit rate was assessed according to RECIST 1.0 and defined as the percentage of participants who experienced a CR, PR, or stable disease (SD) for at least 6 months. CR was defined as complete disappearance of all target and non-target lesions and no new lesions. PR was defined as greater than or equal to (≥) 30 % decrease in the sum of appropriate diameters of all target measurable lesions, no progress in the non-measurable disease, and no new lesions. SD was defined as small changes that do not meet above criteria.
  • Time to Progression [ Time Frame: From the date of enrollment until the date of progressive disease (up to 28 months) ]
    Time to progression was defined as the time from the date of enrollment until the date of progressive disease.
  • Overall response rate (Complete and partial response), tumour assessments according RECIST criteria [ Time Frame: up to 4 years ]
  • Duration of response: Time from objective response to disease progression [ Time Frame: up to 4 years ]
  • Overall Survival [ Time Frame: up to 4 years ]
  • Safety: Incidence of adverse events [ Time Frame: up to 4 years ]
  • Determination of biomarkers indicative for response (serum and tumour tissue analyses) [ Time Frame: up to 4 years ]
Not Provided
Not Provided
 
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants 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 (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.
Not Provided
Interventional
Phase 4
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
    4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
    Other Name: Herceptin
Experimental: Trastuzumab
Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
Interventions:
  • Drug: Docetaxel
  • Drug: Paclitaxel
  • Drug: Trastuzumab
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 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 </= 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
Sexes Eligible for Study: 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
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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