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 |
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| Monitoring | SMS-Oncology |
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| Local datamanagement | ||||
| Funding |
 Funding by KWF |
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| 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.
Documents (public):
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