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

This study has been completed.
Sponsor:
Information provided by:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT00768859
First received: October 7, 2008
Last updated: May 10, 2012
Last verified: May 2012

October 7, 2008
May 10, 2012
September 2008
August 2011   (final data collection date for primary outcome measure)
Pathologic complete response (pCR) rate at surgery [ Time Frame: at the completion of neo-adjuvant chemotherapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00768859 on ClinicalTrials.gov Archive Site
To describe disease-free and overall survival [ Time Frame: during routine follow up visits after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study
Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • HER2 Positive
Drug: paclitaxel, trastuzumab and carboplatin
paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3
Experimental: 1
paclitaxel, trastuzumab and carboplatin
Intervention: Drug: paclitaxel, trastuzumab and carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
May 2012
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00768859
M08TRA, 2008-000987-18
Yes
G.S. Sonke, MD PhD, NKI-AVL
The Netherlands Cancer Institute
Not Provided
Principal Investigator: G S Sonke, MD NKI-AvL
The Netherlands Cancer Institute
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP