Trastuzumab in Treating Women With Metastatic Breast Cancer

NCT00896376 | Completed

• 4 other identifiers: CDR0000626782CALACASS-2005/35CALACASS-PHRC 2005 HerceptineINCA-RECF0618
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; HER2-positive breast cancer

Outcome Measures

Primary Outcomes (2)

• Toxicity, including cardiotoxicity and immuno-allergic reactions

  1 year

• Clinical response as assessed by RECIST criteria

  1 year

Study Arms (1)

trastuzumab

EXPERIMENTAL

Biological: trastuzumab; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

trastuzumab BIOLOGICAL

trastuzumab

laboratory biomarker analysis OTHER

trastuzumab

pharmacological study OTHER

trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• Beauclair S, Formento P, Fischel JL, Lescaut W, Largillier R, Chamorey E, Hofman P, Ferrero JM, Pages G, Milano G. Role of the HER2 [Ile655Val] genetic polymorphism in tumorogenesis and in the risk of trastuzumab-related cardiotoxicity. Ann Oncol. 2007 Aug;18(8):1335-41. doi: 10.1093/annonc/mdm181.

  PMID: 17693647 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jean Marc Ferrero, MD

  Centre Antoine Lacassagne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 11, 2009
• Study Start: December 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

FR (1)