Studieoverzicht - 2006-06 ATX
| Number | 2006-06 ATX | ||||
| Nickname | ATX | ||||
| Status | Closed | Date: 03-12-2010 | |||
| Inclusion closed | |||||
| Other study number(s) | |||||
| Participating parties/groups | |||||
| Full title | Phase II randomized trial of combination therapy of paclitaxel and bevacizumab versus paclitaxel, capecitabine and bevacizumab as first-line treatment for locally recurrent or metastatic breast cancer patients with HER2/neu negative tumor. | ||||
| Phase and type | Randomized Phase II | ||||
| Age | ≥ 18 and ≤ 75 | ||||
| Menopausal status | Both pre- and postmenopausal | ||||
| Indication | Advanced/metastatic | ||||
| Subindication | HER2-, any HR | ||||
| Target sample size | 312 | ||||
| Actual accrual | 312 | Date: 03-12-2010 | |||
| Estimated study completion date | 31-12-2010 | ||||
| CCMO approval | Yes | Date: 02-04-2007 | Nr: NL17213.029.07 | ||
| EudraCT nr. | 2006-006058-83 | ||||
| Trial Register | NTR1348 | ||||
| METC approval | Yes | Date: 25-05-2007 | METC: Vrije Universiteit Medisch Centrum | Nr: 2007/72 | |
| Amendments | Date: | ||||
| KWF-CKS approval | No | Date: | Nr: | ||
| News item | |||||
| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | Vumc, BOOG | ||||
| Principal Investigator(s) | E. Boven, A.H. Honkoop | |||
| 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 020 3462597 |
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| Monitoring | BOOG via SMS-Oncology |
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| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
Design:
Randomization:
Arm A: paclitaxel and bevacizumab.
Arm B: paclitaxel, capecitabine and bevacizumab
Objectives:
To investigate Progression Free Survival (PFS)
Endpoints:
Primary endpoint:
- Progression free survival
Secondary endpoints:
- Overall response rate
- Duration of respons
- Overall survival
- Safety
Main eligibility criteria:
Patients with histologically or cytologically confirmed, HER2/neu-negative, pre- or postmenopausal adenocarcinoma of the breast with measurable or non-measurable locally recurrent or metastatic disease, who are candidates for chemotherapy. Locally recurrent disease must not be amenable to resection and/or radiotherapy with curative intent
Documents (public):
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