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
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
Monitoring IKO
Local datamanagement



Arm A: 4xAC followed by 4 D
Arm B: 6xTAC


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.


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)
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