Studieoverzicht - 2010-04 D-Care

 
Number 2010-04 D-Care
Nickname D-Care
Status Follow up Date: 16-08-2012
Inclusion closed
Other study number(s) Amgen 20060359
Participating parties/groups
Full title A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence
Phase and type Randomized Phase III
Age ≥ 18 yrs
Menopausal status Both pre- and postmenopausal
Indication Adjuvant
Subindication Any HER2, any HR
Target sample size 4500
Actual accrual 4576 (NL 67) Date: 16-08-2012
Estimated study completion date 31-12-2012
CCMO approval Yes Date: Nr: NL32491.098.10 V02
EudraCT nr. 2009-011299-32
Trial Register NCT01077154
METC approval Yes Date: 07-01-2011 METC: METC Zuidwest Holland Nr: 10-071
Amendments No Date:
KWF-CKS approval Not applicable Date: Nr:
News item
Website http://www.boogstudycenter.nl
Sponsor Amgen
Principal Investigator(s) S.C. Linn (for BOOG)
Study manager Amgen: A. Aarts en H. Denecker
BOOG: A.E. van Leeuwen-Stok
Central datamanagement and randomization Amgen
Monitoring Amgen NL
Local datamanagement
Funding
Extra

Design:

Subjects will be randomized in a 1:1 ratio to receive denosumab 120 mg or matching placebo subcutaneously (SC) every 4 weeks (Q4W; ± 7 days) for 6 months followed by denosumab 120 mg or matching placebo SC every 3 months (Q3M; i.e. every 12 weeks ± 14 days) for 4½ years (approximately 54 months), for a total treatment duration of 5 years (approximately 60 months).

Objectives:

Primary:

  • To compare the treatment effect of denosumab with that of placebo on prolonging bone
    metastasis-free survival (BMFS) in subjects with early-stage breast cancer at high risk of disease
    recurrence


Secondary Objectives:
To compare the treatment effect of denosumab with that of placebo on:

  • Disease-free survival (DFS)
  • Overall survival (OS)
  • Distant recurrence-free survival (DRFS)

Safety Objectives:

  • To assess the safety and tolerability of denosumab compared with placebo.
Endpoints:

Primary:

BMFS (determined by the time from randomization to the first observation of bone metastasis or death from any cause)

Secondary:

  • DFS (determined by the time from randomization to the first observation of disease recurrence or death from any cause)
  • OS (determined by the time from randomization to death from any cause)
  • DRFS (determined by the time from randomization to the first observation of distant metastasis or death from any cause)
Main eligibility criteria:

Adjuvant treatment for women with early-stage breast cancer at high risk of disease recurrence receiving standard of care adjuvant/neoadjuvant cancer therapy

Inclusion Criteria:

  • Histologically confirmed, AJCC stage II or III breast cancer
  • High risk of breast cancer recurrence, defined as documented evidence of one or more of

the following criteria:
o Biopsy evidence of breast cancer in regional LN (node positive disease)
o Tumor size > 5 cm (T3) or locally advanced disease (T4)

  • Documented pathological evaluation of the breast cancer for hormone receptor (ER and

PR) status and HER-2 status

  • Subjects must be receiving or be scheduled to receive standard of care adjuvant or

neoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy

Exclusion Criteria:

  • Prior or current evidence of metastatic disease
  • History of breast cancer prior to current diagnosis (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]
  • Osteoporosis requiring treatment
  • Active oral, dental or jaw condition
  • Non-healed dental or oral surgery
  • Use of oral bisphosphonates within the past year
  • Prior or current IV bisphosphonate administration
  • Subject is pregnant or breast feeding
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