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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