Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant (TELEPIK)
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- STATUS
- Recruiting
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- End date
- Jul 31, 2023
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- participants needed
- 20
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- sponsor
- Novartis Pharmaceuticals
Summary
The study is designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
Description
Open-label, single arm, multi-center, Phase II interventional pilot trial. Primary objective will be to assess participant satisfaction with the decentralized clinical trial (DCT) experience.
The trial will enroll men and pre- and post-menopausal women with a HR-positive/HER2-negative ABC (loco regionally recurrent not amenable to curative therapy or metastatic) with a PIK3CA mutation, which progressed on or after endocrine-based treatment.
Participants will receive alpelisib 300 mg daily and fulvestrant 500 mg administered intramuscularly on Cycle 1, Day 1 and Cycle 1, Day 15, and on Day 1 of each cycle thereafter until Cycle 12.
Pre-menopausal women will receive goserelin 3.6 mg on Day 1 of each cycle.
Details
| Condition | Advanced Breast Cancer |
|---|---|
| Treatment | fulvestrant, Alpelisib |
| Clinical Study Identifier | NCT04862143 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 26 April 2022 |
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