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Trastuzumab in Treating Women With Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00896376
First received: May 8, 2009
Last updated: December 18, 2009
Last verified: July 2009
History of Changes
  Purpose

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: 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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 240
Study Start Date: December 2005
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

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

Locations
France
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Jean Marc Ferrero, MD     33-4-9203-1114     jean-marc.ferrerero@nice.fnclcc.fr    
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Investigator: Jean Marc Ferrero, MD Centre Antoine Lacassagne
  More Information

No publications provided

ClinicalTrials.gov 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: December 18, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
HER2-positive breast cancer

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

ClinicalTrials.gov processed this record on May 16, 2013