drugset / Trial / NCT03573648
Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
Phase 2
Active not recruiting
33 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Allegheny Health Network · collabNational Institutes of Health (NIH) · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.
Timeline
- Start
- 2018-11-13
- Primary completion
- 2026-09-30
- Completion
- 2026-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Comparator | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Comparator | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Comparator | Leuprolide | Other / unclassified | 3.75 mg | Intramuscular |
| Comparator | Palbociclib | Small molecule | 125 mg | Oral |
| Comparator | Tamoxifen | Small molecule | 20 mg | Oral |