Trastuzumab in Treating Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896376
• Other study ID #: CDR0000626782
• Secondary ID: CALACASS-2005/35
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: February 8, 2015
• Start date: December 2005
• Est. completion date: September 2010

Study information

• Verified date: February 2015
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• trastuzumab

Other:
• laboratory biomarker analysis

• pharmacological study

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity, including cardiotoxicity and immuno-allergic reactions		1 year	Yes
Primary	Clinical response as assessed by RECIST criteria		1 year	No