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Sponsored by: |
The Netherlands Cancer Institute |
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Information provided by: | The Netherlands Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00768859 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Trastuzumab in a Neo-Adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study |
Estimated Enrollment: | 60 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
paclitaxel, trastuzumab and carboplatin
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Drug: paclitaxel, trastuzumab and carboplatin
paclitaxel; 70 mg/m2 trastuzumab; 2 mg/kg (loading dose 4 mg/kg) carboplatin; AUC = 3
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
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.
Exclusion Criteria:
Contact: G S Sonke, MD PhD | +31205129111 ext 2570 | g.sonke@nki.nl |
Contact: S C Linn, MD PhD | +31205129111 | s.linn@nki.nl |
Netherlands | |
NKI-AVL | Recruiting |
Amsterdam, Netherlands, 1066 CX | |
Contact: G S Sonke, MD PhD +31205129111 ext 2570 g.sonke@nki.nl | |
Contact: S C Linn, MD PhD +31205129111 s.linn@nki.nl | |
Principal Investigator: G S Sonke, MD PhD | |
Catharina Ziekenhuis | Not yet recruiting |
Eindhoven, Netherlands, 5602 ZA | |
Contact: L JC van Warmerdam, MD PhD +31402399111 | |
Principal Investigator: L JC van Warmerdam, MD PhD | |
Kennemer Gasthuis | Not yet recruiting |
Haarlem, Netherlands, 2035 RC | |
Contact: P H Kuijer, MD PhD | |
Principal Investigator: P H Kuijer, MD PhD | |
Leids Universitair Medisch centrum | Not yet recruiting |
Leiden, Netherlands, 2300 RC | |
Contact: J WR Nortier, MD PhD | |
Principal Investigator: J WR Nortier, MD PhD | |
Sint Antonius Ziekenhuis | Not yet recruiting |
Nieuwegein, Netherlands, 3430 EM | |
Contact: M Los, MD PhD | |
Principal Investigator: M Los, MD PhD | |
Medisch Centrum Haaglanden | Not yet recruiting |
Leidschendam, Netherlands, 2262 BA | |
Contact: H M Oosterkamp, MD PhD | |
Principal Investigator: H M Oosterkamp, MD PhD | |
Onze Lieve Vrouwe Gasthuis | Not yet recruiting |
Amsterdam, Netherlands, 1091 HA | |
Contact: B de Valk, MD PhD | |
Principal Investigator: B de Valk, MD PhD | |
Reinier de Graaf Gasthuis | Not yet recruiting |
Delft, Netherlands, 2600 AG | |
Contact: M MEM Bos, MD PhD | |
Principal Investigator: M MEM Bos, MD PhD | |
Medisch Centrum Alkmaar | Recruiting |
Alkmaar, Netherlands, 1800 AM | |
Contact: C H Smorenburg, MD PhD | |
Principal Investigator: C H Smorenburg, MD PhD |
Principal Investigator: | G S Sonke, MD | NKI-AVL |
Responsible Party: | NKI-AVL ( G.S. Sonke, MD PhD ) |
Study ID Numbers: | M08TRA, EudraCT number; 2008-000987-18 |
Study First Received: | October 7, 2008 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00768859 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
breast cancer HER2 positive neo-adjuvant |
trastuzumab paclitaxel carboplatin |
Naphazoline Oxymetazoline Skin Diseases Guaifenesin Phenylephrine Paclitaxel |
Trastuzumab Breast Neoplasms Carboplatin Phenylpropanolamine Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Mitosis Modulators Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |