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Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Toxicity, including cardiotoxicity and immuno-allergic reactions

Safety Issue:

Yes

Principal Investigator

Jean Marc Ferrero, MD

Investigator Affiliation:

Centre Antoine Lacassagne

Authority:

Unspecified

Study ID:

CDR0000626782

NCT ID:

NCT00896376

Start Date:

December 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • HER2-positive breast cancer
  • Breast Neoplasms

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