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

Hoffmann-La Roche32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Docetaxel

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Unnamed facility

Beijing, China

Unnamed facility

Beijing, China

Unnamed facility

Beijing, China

Unnamed facility

Beijing, China

Unnamed facility

Chengdu, China

Unnamed facility

Guangzhou, China

Unnamed facility

Guangzhou, China

Unnamed facility

Guangzhou, China

Unnamed facility

Hangzhou, China

Unnamed facility

Hangzhou, China

...and 7 more locations

Outcomes

Primary Outcomes

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.

Time frame: From the date of informed consent to the date of death or progressive disease (up to 28 months)

Secondary Outcomes

Overall Response Rate

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.

Time frame: up to 28 months

Duration of Response

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.

Time frame: From the time of PR or CR until the date of PD or death (up to 28 months)

Overall Survival

Overall survival was defined as the time from the date of enrollment to the date of death due to any cause.

Time frame: Time from enrollment to the date of death (up to 28 months)

Percentage of Participants With an Adverse Event (AE)

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.

Time frame: Up to 28 days after last infusion of the study drug (28 months)

Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses)

Time frame: up to 28 months

Clinical Benefit Rate

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 frame: up to 28 months

Time to Progression

Time to progression was defined as the time from the date of enrollment until the date of progressive disease.

Time frame: From the date of enrollment until the date of progressive disease (up to 28 months)