Studieoverzicht - 2003-02 Calor

Number 2003-02 Calor
Nickname Calor
Status Closed Date: 31-01-2016
Inclusion closed
Other study number(s) IBCSG 27-02; BIG 1-02; NSABP B-37
Participating parties/groups IBCSG, BIG, NSABP
Full title Randomized clinical trial of adjuvant chemotherapy for radically resected loco-regional relapse of breast cancer; chemotherapy vs. observation.
Phase and type Randomized Phase III
Age ≥18
Menopausal status Both pre- and postmenopausal
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
CCMO approval Not applicable Date: Nr:
EudraCT nr.
Trial Register NCT00074152; EU 20320
METC approval Yes Date: 04-12-2004 METC: Leiden Universitair Medisch Centrum Nr: P04.008
Amendments Yes Date: 13-11-2008
KWF-CKS approval Yes Date: 26-01-2005 Nr: CKTO 2004-05
News item
Sponsor IBCSG
Principal Investigator(s) J.W.R. Nortier, A.H. Westenberg
Study manager
Central datamanagement and randomization
Monitoring Not applicable
Local datamanagement
Funding Logo KWF NweHuisstijl 004-zonder slogan.jpgFunding by KWF


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


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


Primary endpoint:

  • Disease-free survival

Secondary endpoints:

  • Overall survival
  • Systemic disease-free survival
Main eligibility criteria:
  • Radically treated isolated local and/or regional recurrence of invasive breast cancer after mastectomy or breast-conserving surger
  • ER+/- and/or PgR+ / -
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