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INTENS

  • Closed

BOOG 2007-02

General Information

BOOG number

BOOG 2007-02

Nickname

INTENS

Status

  • Closed
Date: 01/05/2009

Other study number

IKO 2005-01

Full title

Sequential vs upfront intensified neoadjuvant chemotherapy in patients with large resectable or locally advanced breast cancer.

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

Contact

Sponsor

MUMC

Principal Investigator(s)

V.C.G. Tjan-Heijnen

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

Monitoring

IKO

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.

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)

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 24/08/2005

EC

CMO Regio Arnhem-Nijmegen
Amendments:
Yes
Date Last Amendment: 04/01/2007

EudraCT number

Not applicable

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