Studieoverzicht - 2013-05 BELLE-3
| Number | 2013-05 BELLE-3 | ||||
| Nickname | BELLE-3 | ||||
| Status | Follow up | Date: 04-03-2016 | |||
| Inclusion closed | 04-03-2016 | ||||
| Other study number(s) | CBKM120F2303 | ||||
| Participating parties/groups | |||||
| Full title | A phase III randomized, double blind placebo controlled study of oral BKM120 in combination with fulvestrant, in the treatment of postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer whose disease has progressed on or after aromatase and mTOR inhibitor treatment. | ||||
| Phase and type | Randomized Phase III | ||||
| Age | ≥18 | ||||
| Menopausal status | Postmenopausal | ||||
| Indication | Advanced/metastatic | ||||
| Subindication | HER2- HR+ | ||||
| Target sample size | 420 | ||||
| Actual accrual | 432 (NL: 22) | Date: 04-03-2016 | |||
| Estimated study completion date | 31-03-2016 | ||||
| CCMO approval | Yes | Date: | Nr: | ||
| EudraCT nr. | |||||
| Trial Register | |||||
| METC approval | Yes | Date: | METC: | Nr: | |
| Amendments | Date: | ||||
| KWF-CKS approval | No | Date: | Nr: | ||
| News item | |||||
| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | Novartis | ||||
| Principal Investigator(s) | V.C.G. Tjan-Heijnen (MUMC) | |||
| Study manager | G. Frans (Novartis) A.E. van Leeuwen-Stok (BOOG Study Center) |
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| Central datamanagement and randomization | Novartis | |||
| Monitoring | Novartis | |||
| Local datamanagement | ||||
| Funding | ||||
| Extra | E. van Druten (Research Nurse - coordination, RdGG) | |||
Design:
Objectives:
This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.
Endpoints:
Primary Outcome Measures: Progression Free Survival (PFS).
Secondary Outcome Measures: Overall survival (OS); Overall response rate (ORR); Clinical benefit rate (CBR); Type, frequency and severity of adverse events; Plasma concentration-time profiles of BKM120 - pharmacokinetics (PK); Patient reported outcome for global health status/QoL
Main eligibility criteria:
Inclusion criteria:
- Postmenopausal women
- Breast cancer that is locally advanced or metastatic
- HER2 negative disease, and a known positive hormone receptor status (common breast cancer classification tests)
- A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
- Prior treatment with AIs
- Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
- Adequate bone marrow and organ function
Exclusion criteria:
- More than 1 prior chemotherapy given for locally advanced or metastatic disease
- Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant
- Symptomatic CNS metastases
- Concurrent malignancy or malignancy within 3 years prior to start of study treatment
- Certain drugs or radiation within 2-4 weeks of enrollment
- Increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent
- Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
- Hypersensitivity to fulvestrant treatment excipients
- Certain scores on an anxiety and depression mood questionnaire given at screening
- Other protocol defined criteria may apply
Documents (public):
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