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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301729
• Other study ID #: ML25288
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2011
• Last updated: July 1, 2016
• Start date: March 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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 [Herceptin]
4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival, tumour assessments according to RECIST 1.0		up to 4 years	No
Secondary	Overall response rate (complete or partial response), tumour assessments according to RECIST 1.0		up to 4 years	No
Secondary	Duration of response: Time from objective response to disease progression		up to 4 years	No
Secondary	Overall survival		up to 4 years	No
Secondary	Safety: Incidence of adverse events		up to 4 years	No
Secondary	Exploratory: Determination of biomarkers indicative for response (serum and tumour tissue analyses)		up to 4 years	No
Secondary	Clinical benefit rate (defined as complete response or partial response or stable disease for at least 6 months)		up to 4 years	No