Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study

NCT ID: NCT00768859

Last Updated: 2012-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-05-31

Brief Summary

To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer

Conditions

Breast Cancer; HER2 Positive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

paclitaxel, trastuzumab and carboplatin

Group Type: EXPERIMENTAL

paclitaxel, trastuzumab and carboplatin

Intervention Type: DRUG

paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3

Interventions

paclitaxel, trastuzumab and carboplatin

paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed infiltrating breast cancer.
• Stage II or stage III breast cancer.28 '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.
• 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 a 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.

• Age ≥18
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix B)
• Adequate bone marrow function (ANC >1.0 x 109/l, platelets >100 x 109/l)
• Adequate hepatic function (ALAT, ASAT and bilirubin <2 times upper limit of normal)
• Adequate renal function (creatinine clearance >60 ml/min)
• LVEF ≥50% measured by echocardiography or MUGA
• Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• Signed written informed consent

Exclusion Criteria

• No previous radiation therapy or chemotherapy
• 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.
• No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
• No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.
• No concurrent anti-cancer treatment or another investigational drug

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

NKI-AVL

Principal Investigators

G S Sonke, MD

Role: PRINCIPAL_INVESTIGATOR

NKI-AvL

Locations

Medisch Centrum Alkmaar

Alkmaar, , Netherlands

NKI-AVL

Amsterdam, , Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Reinier de Graaf Gasthuis

Delft, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Kennemer Gasthuis

Haarlem, , Netherlands

Leids Universitair Medisch centrum

Leiden, , Netherlands

Medisch Centrum Haaglanden

Leidschendam, , Netherlands

Sint Antonius Ziekenhuis

Nieuwegein, , Netherlands

Countries

Netherlands

Other Identifiers

2008-000987-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M08TRA

Identifier Type: -

Identifier Source: org_study_id