Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study - TRAIN study
- Conditions
- HER2 positive breat cancerMedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer
- Registration Number
- EUCTR2008-000987-18-NL
- Lead Sponsor
- etherlands Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
1. Histologically or cytologically confirmed infiltrating breast cancer.
2. Stage II or stage III disease. 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of >2 mm in diameter at sentinel node biopsy. Stage IIA patients are eligible if the tumor is >3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
•>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
•>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating HER2 gene amplification defined as a FISH ratio of HER2 gene copies to chromosome 17 signals of >2.2. or as >5 HER2 gene copies per nucleus in CISH analysis.
Patients with negative or equivocal overall result (FISH test ratio of <2.2, <6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.
4. Age =18
5. Eastern Cooperative Oncology Group (ECOG) performance status =1
6. Adequate bone marrow function (ANC >1.0 x 109/l, platelets >100 x 109/l)
7. Adequate hepatic function (ALAT, ASAT and bilirubin <2 times upper limit of normal)
8. Adequate renal function (creatinine clearance >60 ml/min)
9. LVEF =50% measured by echocardiography or MUGA
10. Signed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. No previous radiation therapy or chemotherapy
2. No other malignancy except carcinoma in situ, unless the other malignancy was treated =5 years ago with curative intent without the use of chemotherapy or radiation therapy.
3. Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
4. Evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. When the isotope bone scan is doubtful and plain radiographs do not explain the abnormality, MRI or CT-scan must be performed.
5. Concurrent anti-cancer treatment or another investigational drug.
6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the activity of the combination of paclitaxel, trastuzumab, and carboplatin as neo-adjuvant treatment in patients with stage II or III breast cancer.;Primary end point(s): Pathologic complete response (pCR) rate at surgery.;Secondary Objective: 1.To describe disease-free and overall survival<br>2.To identify gene expression profiles predictive for pCR after PTC treatment<br>3.To describe the toxic effects of the PTC combination<br>4.To explore relations of TOP2a amplification, pTEN status, PI3kinase mutation, and p95her2 status with pCR rate<br>5.To describe the percentage of conservative surgery.
- Secondary Outcome Measures
Name Time Method