PUMA-NER-6201
25 Nov 2020
Trial Summary
An open-label, Phase 2 study that will investigate the incidence of diarrhea in HER2+ breast cancer patients receiving neratinib with intensive loperamide diarrhea prophylaxis, alone and in combination with anti-inflammatory treatment.
Acronym:
PUMA-NER-6201
ACTRN/NCT /ethics:
NCT02400476
Scientific title:
An open-label study to characterize the incidence and severity of diarrhea in patients with early-stage HER2+ breast cancer treated with Neratinib and intensive Loperamide prophylaxis.
Sponsor / Cooperative group:
Puma Biotechnology/ Novoteh
Trial & Patient Characteristics
| Cancer Type | Breast |
|---|---|
| Trial Type | Treatment |
| Phase | Phase II |
| Age Range | 18 years and older |
| Sex | Both |
| Tumour Stream | Breast cancer |
| Cancer Stage | Early\In Situ |
| Anticipated Start Date | 2015-02-01 |
| Anticipated End Date | 2019-04-01 |
Participating Hospitals
| Hospital | Ashford Cancer Centre Research |
|---|---|
| Clinical Trial Coordinator | Sue Yeend |
| syeend@adelaidecancercentre.com.au | |
| Phone | 08 8292 2240 |
| Principal Investigator | Dr Kerry Cheong |
| Recruitment Status | Recruitment on Hold |