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Trastuzumab in Treating Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00896376
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Other: laboratory biomarker analysis Other: pharmacological study Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: trastuzumab Biological: trastuzumab Other: laboratory biomarker analysis Other: pharmacological study



Primary Outcome Measures :
  1. Toxicity, including cardiotoxicity and immuno-allergic reactions [ Time Frame: 1 year ]
  2. Clinical response as assessed by RECIST criteria [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896376


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

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00896376     History of Changes
Other Study ID Numbers: CDR0000626782
CALACASS-2005/35
CALACASS-PHRC 2005 Herceptine
INCA-RECF0618
First Posted: May 11, 2009    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Centre Antoine Lacassagne:
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