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 |
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| Central datamanagement and randomization | Amgen | |||
| Monitoring | Amgen NL | |||
| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
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).
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.
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)
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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