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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01301729
First received: February 9, 2011
Last updated: November 2, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Paclitaxel
Drug: Trastuzumab
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: From the date of informed consent to the date of death or progressive disease (up to 28 months) ]
    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.


Secondary Outcome Measures:
  • Overall Response Rate [ Time Frame: up to 28 months ]
    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.

  • Duration of Response [ Time Frame: From the time of PR or CR until the date of PD or death (up to 28 months) ]
    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.

  • Overall Survival [ Time Frame: Time from enrollment to the date of death (up to 28 months) ]
    Overall survival was defined as the time from the date of enrollment to the date of death due to any cause.

  • Percentage of Participants With an Adverse Event (AE) [ Time Frame: Up to 28 days after last infusion of the study drug (28 months) ]
    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.

  • Determination of Biomarkers Indicative for Response (Serum and Tumour Tissue Analyses) [ Time Frame: up to 28 months ]
  • Clinical Benefit Rate [ Time Frame: up to 28 months ]
    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 to Progression [ Time Frame: From the date of enrollment until the date of progressive disease (up to 28 months) ]
    Time to progression was defined as the time from the date of enrollment until the date of progressive disease.


Enrollment: 32
Study Start Date: March 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Docetaxel
100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks)
Drug: Paclitaxel
90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks)
Drug: Trastuzumab
4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
Other Name: Herceptin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01301729

Locations
China
Beijing, China, 100021
Beijing, China, 100071
Beijing, China, 100142
Beijing, China, 100730
Chengdu, China, 610041
Guangzhou, China, 510060
Guangzhou, China, 510515
Guangzhou, China
Hangzhou, China, 310009
Hangzhou, China, 310022
Harbin, China, 150081
Nanjing, China, 210009
Shanghai, China, 200032
Shenyang, China, 110001
Wuhan, China, 430022
Wuhan, China, 430030
Zhengzhou, China, 450008
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01301729     History of Changes
Other Study ID Numbers: ML25288
Study First Received: February 9, 2011
Results First Received: August 17, 2016
Last Updated: November 2, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Taxane
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on March 24, 2017