Trials / Terminated
TerminatedNCT05966584
A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib. Researchers think adding benralizumab to the standard-of-care hormone treatment and alpelisib may prevent the patient from getting a rash.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Benralizumab | Benralizumab 30mg subcutaneously on day -1. |
| DRUG | fulvestrant or AIs) and PI3K inhibition (alpelisib) | SOC endocrine therapy (fulvestrant or AIs) and PI3K inhibition (alpelisib) |
Timeline
- Start date
- 2023-07-06
- Primary completion
- 2024-08-02
- Completion
- 2024-08-02
- First posted
- 2023-07-28
- Last updated
- 2024-08-29
- Results posted
- 2024-08-29
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05966584. Inclusion in this directory is not an endorsement.