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Calor

  • Closed

BOOG 2003-02

General Information

BOOG number

BOOG 2003-02

Nickname

Calor

Status

  • Closed
Date: 31/01/2016

Participating parties / group

IBCSG, BIG, NSABP

Other study number

IBCSG 27-02; BIG 1-02; NSABP B-37

Full title

Randomized clinical trial of adjuvant chemotherapy for radically resected loco-regional relapse of breast cancer; chemotherapy vs. observation.

Indication

  • Adjuvant

Subindication

Any HER2, any HR

Target sample size

265

Actual accrual

162 (NL12)
Date: 02/02/2010

Estimated study completion date

31/12/2012

Contact

Sponsor

IBCSG

Principal Investigator(s)

J.W.R. Nortier, A.H. Westenberg

Monitoring

Not applicable

Funding

Funding by KWF

Other

http://www.ibcsg.org

Design

Randomization: Arm A: observation (+/- Radiation Therapy) Arm B: chemotherapy (+/- Radiation Therapy)

Objectives

To evaluate the efficacy of adjuvant chemotherapy after radical local treatment of a first loco-regional recurrence of breast cancer.

Endpoints

Primary endpoint:

  • Disease-free survival

Secondary endpoints:

  • Overall survival
  • Systemic disease-free survival

Eligibility Criteria

Radically treated isolated local and/or regional recurrence of invasive breast cancer after mastectomy or breast-conserving surger ER+/- and/or PgR+ / –

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 04/12/2004
Nr:P04.008

EC

Leiden Universitair Medisch Centrum
Amendments:
Yes
Date Last Amendment: 13/11/2008

Trial Register

NCT00074152; EU 20320

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