Trastuzumab in Treating Women With Metastatic Breast Cancer

Centre Antoine Lacassagne

Status

Completed

Conditions

Breast Cancer

Treatments

Other: pharmacological study

Biological: trastuzumab

Other: laboratory biomarker analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT00896376

CDR0000626782

CALACASS-PHRC 2005 Herceptine

INCA-RECF0618

CALACASS-2005/35

Details and patient eligibility

About

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.

Full 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.

Enrollment

49 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: