A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
NCT ID: NCT01301729
Last Updated: 2016-12-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2011-03-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Docetaxel
100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks)
Paclitaxel
90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks)
Trastuzumab
4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
Interventions
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Docetaxel
100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks)
Paclitaxel
90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks)
Trastuzumab
4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Chengdu, , China
Guangzhou, , China
Guangzhou, , China
Guangzhou, , China
Hangzhou, , China
Hangzhou, , China
Harbin, , China
Nanjing, , China
Shanghai, , China
Shenyang, , China
Wuhan, , China
Wuhan, , China
Zhengzhou, , China
Countries
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Other Identifiers
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ML25288
Identifier Type: -
Identifier Source: org_study_id