Clinical trial NCT01301729: A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From the date of informed consent to the date of death or progressive disease (up to 28 months)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: up to 28 months
measure: Duration of Response
timeFrame: From the time of PR or CR until the date of PD or death (up to 28 months)
measure: Overall Survival
timeFrame: Time from enrollment to the date of death (up to 28 months)
measure: Percentage of Participants With an Adverse Event (AE)
timeFrame: Up to 28 days after last infusion of the study drug (28 months)
measure: Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses)
timeFrame: up to 28 months
measure: Clinical Benefit Rate
timeFrame: up to 28 months
measure: Time to Progression
timeFrame: From the date of enrollment until the date of progressive disease (up to 28 months)
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Beijing
country: China
city: Chengdu
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Hangzhou
country: China
city: Harbin
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Wuhan
country: China
city: Wuhan
country: China
city: Zhengzhou
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: