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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
  Purpose

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 Intervention Phase
Breast Cancer
HER2 Positive
Drug: paclitaxel, trastuzumab and carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • Pathologic complete response (pCR) rate at surgery [ Time Frame: at the completion of neo-adjuvant chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe disease-free and overall survival [ Time Frame: during routine follow up visits after surgery ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: September 2008
Study Completion Date: May 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00768859

Locations
Netherlands
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1800 AM
NKI-AVL
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
Investigators
Principal Investigator: G S Sonke, MD NKI-AvL
  More Information

No publications provided

Responsible Party: G.S. Sonke, MD PhD, NKI-AVL
ClinicalTrials.gov Identifier: NCT00768859     History of Changes
Other Study ID Numbers: M08TRA, 2008-000987-18
Study First Received: October 7, 2008
Last Updated: May 10, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by The Netherlands Cancer Institute:
breast cancer
HER2 positive
neo-adjuvant
trastuzumab
paclitaxel
carboplatin

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Paclitaxel
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 23, 2014