A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Patients 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: October 6, 2014
Last verified: October 2014
  Purpose

This single arm, open-label study will evaluate the efficacy and safety of Herce ptin (trastutumab) in combination with a taxane as first line therapy in patient s with HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant He rceptin treatment. Patients will receive Herceptin (loading dose of 4 mg/kg intr avenously [iv], 2 mg/kg iv weekly thereafter) with 6 3-week cycles of either doc etaxel (100 mg/m2 iv every 3 weeks) or paclitaxel (90 mg/m2 every week). Hercept in treatment will be continued until disease progression or unacceptable toxicit y occurs.


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: paclitaxel
Drug: trastuzumab [Herceptin]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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, tumour assessments according to RECIST criteria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (Complete and partial response), tumour assessments according RECIST criteria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Duration of response: Time from objective response to disease progression [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Determination of biomarkers indicative for response (serum and tumour tissue analyses) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm 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 [Herceptin]
4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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, 100730
Beijing, China, 100142
Chengdu, China, 610041
Guangdong Province, China, 510000
Guangzhou, China, 510060
Guangzhou, China, 510515
Hangzhou, China, 310022
Hangzhou, China, 310009
Harbin, China, 150081
Jiangsu, China, 210009
Shanghai, China, 200032
Shenyang, China, 110001
Wuhan, China, 430030
Wuhan, China, 430022
Zhengzhou, China, 450008
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01301729     History of Changes
Other Study ID Numbers: ML25288
Study First Received: February 9, 2011
Last Updated: October 6, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014