Trastuzumab in Treating Women With Metastatic Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
Centre Antoine Lacassagne Identifier:
First received: May 8, 2009
Last updated: February 8, 2015
Last verified: February 2015

RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This clinical trial is studying the side effects of trastuzumab in treating women with metastatic breast cancer.

Condition Intervention
Breast Cancer
Biological: trastuzumab
Other: laboratory biomarker analysis
Other: pharmacological study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Toxicity, including cardiotoxicity and immuno-allergic reactions [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Clinical response as assessed by RECIST criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: December 2005
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: trastuzumab Biological: trastuzumab Other: laboratory biomarker analysis Other: pharmacological study

Detailed Description:



  • To evaluate the predictive value of genetic factors on the toxicity and efficacy of a trastuzumab-based therapy in women with metastatic breast cancer.


  • To analyze tumor factors potentially related to the efficacy of trastuzumab (i.e., expression of proteins involved in cell proliferation and survival).

OUTLINE: This is a multicenter study.

Patients receive standard treatment with trastuzumab. Blood is collected periodically for pharmacogenetic analysis.


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


  • Histologically confirmed breast cancer

    • Metastatic disease, defined by the existence of a secondary tumor localization radiologically (i.e., by radiography, CT scan, MRI scan, or ultrasound) or scintigraphically confrimed
  • Evaluable disease
  • Beginning first-line metastatic treatment with trastuzumab (Herceptin®) with or without chemotherapy
  • Primary tumor must overexpress HER2 (IHC 3+ OR IHC 2+ and FISH+ OR FISH+)
  • Hormone receptor status not specified
  • No brain metastasis


  • Menopausal status not specified
  • Life expectancy > 3 months
  • Able to undergo cardiotoxicity evaluation every 4 months by measuring LVEF via an isotopic method or ultrasound with systematic registration
  • No chronic uncontrolled disease
  • No heart failure
  • No respiratory failure or hypoxemia
  • No history of another primary cancer except for basal cell carcinoma of the skin
  • No severe uncontrolled infection
  • No psychological incapacity


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT00896376

Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Study Chair: Jean Marc Ferrero, MD Centre Antoine Lacassagne
  More Information

No publications provided

Responsible Party: Centre Antoine Lacassagne Identifier: NCT00896376     History of Changes
Other Study ID Numbers: CDR0000626782, CALACASS-2005/35, CALACASS-PHRC 2005 Herceptine, INCA-RECF0618
Study First Received: May 8, 2009
Last Updated: February 8, 2015
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Centre Antoine Lacassagne:
stage IV breast cancer
HER2-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 27, 2015