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Clinical Trials/EUCTR2013-001863-21-NL
EUCTR2013-001863-21-NL
Active, not recruiting
Not Applicable

Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study - TRAIN-2

BOOG Study Center0 sitesMay 17, 2013
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ConditionsBreast cancer, HER2 positive, stage II or IIIMedDRA version: 18.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsHerceptinCarboplatine SandozTaxolEndoxan5-Fluorouracil SandozEpirubicine HCl SandozPerjeta

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast cancer, HER2 positive, stage II or III
Sponsor
BOOG Study Center
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 17, 2013
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
BOOG Study Center

Eligibility Criteria

Inclusion Criteria

  • •1\.Histologically confirmed infiltrating breast cancer.
  • •2\.Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG\-PET scan.
  • •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\+)
  • •HER2 gene amplification defined as \=6 HER2 gene copies per nucleus by in situ hybridization.
  • •4\.Age \=18
  • •5\.Eastern Cooperative Oncology Group performance status \=1
  • •6\.LVEF \=50% measured by echocardiography or MUGA
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •1\.Previous radiation therapy or chemotherapy
  • •2\.Pregnancy, breast feeding
  • •3\.Evidence of distant metastases.
  • •4\.Evidence of bilateral infiltrating breast cancer
  • •5\.Concurrent anti\-cancer treatment or another investigational drug.

Outcomes

Primary Outcomes

Not specified

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