Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Hydroxychloroquine sulfate, Plaquenil
HCQ · 1 trial · 1 indication
Endpoint: Proportion of subjects in each treatment arm with clearance of DTCs at the end of 6 cycles of therapy.
| Arm | Type | Description |
|---|---|---|
| HCQ | EXPERIMENTAL | Patients will receive HCQ, 600 mg twice daily D1-28 of each 28-day cycle. |
| Avelumab | EXPERIMENTAL | Patients will receive Avelumab, 10 mg/kg, IV, D1 and D15 of each 28-day cycle. |
| Palbociclib and Avelumab | EXPERIMENTAL | Patients will receive Palbociclib 125 mg daily, by mouth on D1-21 concurrently with Avelumab, 10 mg/kg IV on D1 and D15 of each 28-day cycle |
| Palbociclib and HCQ | EXPERIMENTAL | Patients will receive Palbociclib 75 mg daily, by mouth on D1-28 concurrently with HCQ, 600 mg twice daily D1-28 of each 28-day cycle. |
| Name | Type | Description |
|---|---|---|
| HCQ | DRUG | 600 mg tablets twice daily D1-28 of each 28-day cycle |
| Avelumab | DRUG | 10 mg/kg, IV, D1 and D15 of each 28-day cycle |
| Palbociclib | DRUG | 125 mg capsule daily, by mouth on D1-21 concurrently with Avelumab. Or 75 mg capsule daily, by mouth on D1-28 concurrently with HCQ. |
Inclusion Criteria: * Bone marrow aspirate after completion of all definitive therapy demonstrates detectable DTCs (via IHC) as performed by central laboratory assessment at University of Pennsylvania. * History of stage II-III histologically-confirmed ER+/Her2 neg invasive breast cancer with no ev...
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