Neoadjuvant Study of Abemaciclib, Durvalumab, and an Aromatase Inhibitor Early Stage Breast Cancer
Part of paid clinical trials in Stony Brook, New York.
- Sponsor
- Alison Stopeck
- Study ID
- NCT04088032
- Phase
- EARLY_PHASE1
- Status
- Withdrawn
Conditions
- Breast Cancer Female
- Hormone Receptor Positive Malignant Neoplasm of Breast
- Locally Advanced Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Abemaciclib, durvalumab and aromatase inhibitor — DRUGSubjects will receive standard therapy with an aromatase inhibitor (exemestane, anastrozole, or letrozole), combined with the experimental treatment of abemaciclib and durvalumab
Study Details
The purpose of this study is to test the efficacy, safety and tolerability of a combination of immunotherapy and anticancer drugs presurgery in patients with hormone-receptor positive breast cancer.
Key Dates
- Start date
- Oct 1, 2019
- Status verified
- Jul 2020
- Primary completion
- Dec 31, 2020
- Completion
- Dec 31, 2020
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ActiveExperimental treatment
Primary Outcome Measure
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Through study completion, up to 24 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stony Brook University Cancer Center | Stony Brook | New York | 11794 | - |
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