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
1 other identifier
interventional
32
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 breast-cancer
Started Mar 2011
Typical duration for phase_4 breast-cancer
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
December 29, 2016
CompletedDecember 29, 2016
November 1, 2016
3.3 years
February 9, 2011
August 17, 2016
November 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
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.
From the date of informed consent to the date of death or progressive disease (up to 28 months)
Secondary Outcomes (7)
Overall Response Rate
up to 28 months
Duration of Response
From the time of PR or CR until the date of PD or death (up to 28 months)
Overall Survival
Time from enrollment to the date of death (up to 28 months)
Percentage of Participants With an Adverse Event (AE)
Up to 28 days after last infusion of the study drug (28 months)
Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses)
up to 28 months
- +2 more secondary outcomes
Study Arms (1)
Trastuzumab
EXPERIMENTALParticipants 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
4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Unknown Facility
Beijing, 100021, China
Unknown Facility
Beijing, 100071, China
Unknown Facility
Beijing, 100142, China
Unknown Facility
Beijing, 100730, China
Unknown Facility
Chengdu, 610041, China
Unknown Facility
Guangzhou, 510060, China
Unknown Facility
Guangzhou, 510515, China
Unknown Facility
Guangzhou, China
Unknown Facility
Hangzhou, 310009, China
Unknown Facility
Hangzhou, 310022, China
Unknown Facility
Harbin, 150081, China
Unknown Facility
Nanjing, 210009, China
Unknown Facility
Shanghai, 200032, China
Unknown Facility
Shenyang, 110001, China
Unknown Facility
Wuhan, 430022, China
Unknown Facility
Wuhan, 430030, China
Unknown Facility
Zhengzhou, 450008, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2011
First Posted
February 23, 2011
Study Start
March 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
December 29, 2016
Results First Posted
December 29, 2016
Record last verified: 2016-11