Studieoverzicht - 2008-03 HAT

 
Number 2008-03 HAT
Nickname HAT
Status Closed Date: 12-09-2013
Inclusion closed
Other study number(s)
Participating parties/groups
Full title A randomized phase II study of concomitant trastuzumab, bevacizumab with paclitaxel versus trastuzumab, bevacizumab, followed by the combination of trastuzumab, bevacizumab and paclitaxel at progression, as first-line treatment for metastatic breast cancer patients with HER2-neu overexpression.
Phase and type Randomized Phase II
Age ≥ 18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2+, any HR
Target sample size 84
Actual accrual 84 Date: 12-09-2013
Estimated study completion date 31-12-2013
CCMO approval Yes Date: 11-07-2008 Nr: NL23763.031.08
EudraCT nr. 2008-003834-12
Trial Register 3483, NTR1349
METC approval Yes Date: 14-01-2009 METC: Nederlands Kanker Instituut Nr: PTC09.0140/M08HAT
Amendments Yes Date: 01-03-2010
KWF-CKS approval Yes Date: 26-03-2009 Nr: CKTO 2009-4398
News item
Website http://www.boogstudycenter.nl
Sponsor Borstkanker Onderzoek Groep
Principal Investigator(s) S. Sleijfer
Study manager A.E. van Leeuwen-Stok
Central datamanagement and randomization IKNL locatie Amsterdam, Trialbureau
PO Box 9236
1006 AE Amsterdam
Email amsterdam.trialbureau@iknl.nl
Tel 020 3462544
Fax 088 – 234 6011
Monitoring SMS-Oncology
Local datamanagement
Funding Logo KWF.jpgFunding by KWF
Extra

Design:

Randomization:
Arm A: trastuzumab, bevacizumab with paclitaxel.
Arm B: trastuzumab, bevacizumab, followed by the combination of trastuzumab, bevacizumab and paclitaxel at progression

Objectives:

Primary objective:
To establish whether concomitant therapy of trastuzumab, bevacizumab with paclitaxel (regimen A) and/or trastuzumab and bevacizumab followed by the combination of trastuzumab, bevacizumab, and paclitaxel at progression (regimen B) deserves to be further studied.

Endpoints:

Primary endpoint:

  • Progression-free survival rate at 1 year

Secondary endpoints: To evaluate:

  • Median progression-free survival
  • Median overall survival (OS)
  • Best Overall Response (OR)
  • Duration of Response (DR)
  • To determine the safety and tolerability of both regimens
Main eligibility criteria:
  • Pre- and postmenopausal patients with locally recurrent breast cancer that cannot be treated with curative intent by local treatment (surgery, radiotherapy +/- hyperthermia) or metastatic HER2 positive breast cancer.
  • Patients with HER2 positive MBC who have received trastuzumab in the adjuvant setting are allowed to be enrolled, provided they received at least 10 months of therapy with trastuzumab and ≥ 6 months has elapsed since last adjuvant administration of trastuzumab.
  • Patients with HER2 positive MBC who have received a taxane in the adjuvant setting are allowed to be enrolled, provided ≥6 months had elapsed since last adjuvant administration of taxane and taxane-related toxicity is resolved to less than grade 2.
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