Clinical trial · Interventional
Trastuzumab in Treating Women With Metastatic Breast Cancer
Prospective Multicenter Study of Genetic Factors Predictive of the Pharmacodynamics of Trastuzumab in Patients With Metastatic Breast Cancer
NCT00896376CI-TRIAL-00111640completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- trastuzumab
- interventionNames
- Biological: trastuzumab
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (2)
- measure
- Toxicity, including cardiotoxicity and immuno-allergic reactions
- timeFrame
- 1 year
- measure
- Clinical response as assessed by RECIST criteria
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTBeauclair 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