Studieoverzicht - 2007-02 INTENS
| Number | 2007-02 INTENS | ||||
| Nickname | INTENS | ||||
| Status | Closed | Date: 01-05-2009 | |||
| Inclusion closed | |||||
| Other study number(s) | IKO 2005-01 | ||||
| Participating parties/groups | |||||
| Full title | Sequential vs upfront intensified neoadjuvant chemotherapy in patients with large resectable or locally advanced breast cancer. | ||||
| Phase and type | Randomized Phase III | ||||
| Age | ≥18 and ≤70 | ||||
| Menopausal status | Both pre- and postmenopausal | ||||
| Indication | Neoadjuvant | ||||
| Subindication | Any HER2, any HR | ||||
| Target sample size | 200 | ||||
| Actual accrual | 202 | Date: 01-05-2009 | |||
| Estimated study completion date | 01-05-2009 | ||||
| CCMO approval | Not applicable | Date: | Nr: | ||
| EudraCT nr. | Not applicable | ||||
| Trial Register | |||||
| METC approval | Yes | Date: 24-08-2005 | METC: CMO Regio Arnhem-Nijmegen | Nr: | |
| Amendments | Yes | Date: 04-01-2007 | |||
| KWF-CKS approval | No | Date: | Nr: | ||
| News item | |||||
| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | MUMC | ||||
| Principal Investigator(s) | V.C.G. Tjan-Heijnen | |||
| Study manager | ||||
| Central datamanagement and randomization | Trialoffice IKO Radboud University Nijmegen, Medical Centre PO Box 9101, HP 485 6500 HB Nijmegen Tel 024 361 68 37 Fax 024 361 90 80 E-mail trialiko@onco.umcn.nl |
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| Monitoring | IKO | |||
| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
Design:
Randomization:
Arm A: 4xAC followed by 4 D
Arm B: 6xTAC
Objectives:
To compare the efficacy and tolerability of neoadjuvant chemotherapy with AC followed by T (adriamycine, cyclophosphamide, taxotere) versus TAC (with upfront T) in patients with large resectable or locally advanced breast cancer.
Endpoints:
Primary endpoint
- Pathologic complete response (pCR) rate to neoadjuvant chemotherapy at surgery.
Secondary endpoints:
- The delivered chemotherapy dose and dose-intensity of both chemotherapy regimens.
- The tolerability (grade 3 / 4 CTC toxicities) of both chemotherapy regimens.
- The clinical responses (partial and complete according to RECIST) of neoadjuvant chemotherapy correlated to pathological responses after neoadjuvant chemotherapy.
- The value of breast MRI in evaluating response to neoadjuvant chemotherapy as compared to clinical palpation, ultrasound techniques and histo-pathological outcome.
- The false-negative rate of the sentinal node (SN) biopsy after neoadjuvant chemotherapy.
- The disease-free (DFS) and overall survival (OS) after 3 and 5 years follow-up.
- The relation between pCR and DFS/OS.
- The feasibility of the criteria for reporting pathological tumour response in surgical breast and axillary node resection specimens.
- The prognostic and predictive value of tumour- and molecular markers, including ER, PgR, c-erbB2, microarray and other tumour characteristic analyses.
Main eligibility criteria:
- Large resectable or locally advanced breast cancer (T2 ≥3 cm, T3, or T4, and/or LN positive)
- Measurable disease
- ≥18 years and ≤70 years
- Excluded are pts with advanced pulmonary disease of any cause (oxygen dependent)
Documents (public):
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