Status:
COMPLETED
Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery
Lead Sponsor:
National Cancer Institute, France
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: Primary * Compare the disease-free survival of women with nonmetastatic, resectable breast cancer treated with adjuvant trastuzumab (Herceptin®) for 6 months vs 12 months. Secondary * ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Nonmetastatic disease
- Positive or negative axillary nodes
- Tumor size ≥ 10 mm
- Resectable disease
- Must have received ≥ 4 courses of chemotherapy for this disease
- A 12-month adjuvant treatment with trastuzumab (Herceptin®) has been initiated
- Informed consent form must be signed between the third and sixth months of trastuzumab therapy
- Overexpression of HER-2 in the invasive component of the primary tumor as indicated by 1 of the following:
- 3+ by immunohistochemistry (IHC)
- 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- LVEF considered favorable for continuing trastuzumab treatment as measured by echocardiography or MUGA at 2-4 months after beginning adjuvant trastuzumab
- No serious cardiac illness or medical condition precluding trastuzumab treatment, including any of the following:
- History of documented congestive heart failure
- High-risk uncontrolled arrhythmias
- Angina pectoris requiring antianginal medication
- Severe dyspnea at rest or oxygen-dependent
- No known hypersensitivity to trastuzumab, murine proteins, or any of the excipients
- Not pregnant or nursing
- No social, geographical, or psychological condition that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Other prior anti-HER-2 therapy allowed
- No prior trastuzumab other than initiation of trastuzumab adjuvant therapy
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
3400 Patients enrolled
Trial Details
Trial ID
NCT00381901
Start Date
May 1 2006
Last Update
May 13 2011
Active Locations (82)
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1
Centre Paul Papin
Angers, France, 49036
2
Centre Hospitalier d'Annecy
Annecy, France, 74011 Cedex
3
Centre Hospitalier La Fontonne
Antibes, France, 06600
4
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107