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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768859
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : May 11, 2012
Information provided by:
The Netherlands Cancer Institute

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

Condition or disease Intervention/treatment Phase
Breast Cancer HER2 Positive Drug: paclitaxel, trastuzumab and carboplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study
Study Start Date : September 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
paclitaxel, trastuzumab and carboplatin
Drug: paclitaxel, trastuzumab and carboplatin
paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3

Primary Outcome Measures :
  1. Pathologic complete response (pCR) rate at surgery [ Time Frame: at the completion of neo-adjuvant chemotherapy ]

Secondary Outcome Measures :
  1. To describe disease-free and overall survival [ Time Frame: during routine follow up visits after surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768859

Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1800 AM
Amsterdam, Netherlands, 1066 CX
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 HA
Reinier de Graaf Gasthuis
Delft, Netherlands, 2600 AG
Catharina Ziekenhuis
Eindhoven, Netherlands, 5602 ZA
Kennemer Gasthuis
Haarlem, Netherlands, 2035 RC
Leids Universitair Medisch centrum
Leiden, Netherlands, 2300 RC
Medisch Centrum Haaglanden
Leidschendam, Netherlands, 2262 BA
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands, 3430 EM
Sponsors and Collaborators
The Netherlands Cancer Institute
Principal Investigator: G S Sonke, MD NKI-AvL

Responsible Party: G.S. Sonke, MD PhD, NKI-AVL Identifier: NCT00768859     History of Changes
Other Study ID Numbers: M08TRA
2008-000987-18 ( EudraCT Number )
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012

Keywords provided by The Netherlands Cancer Institute:
breast cancer
HER2 positive

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action