Clinical trial NCT03400254: Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")
Official title: A Phase Ib/II Trial of Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")
Conditions: Breast Cancer
Summary: This clinical trial will assess the safety and early efficacy of the role of gedatolisib and hydroxychloroquine in early-stage breast cancer patients with residual disease and evidence of disseminated tumor cells (DTCs) on bone marrow aspirate after neoadjuvant chemotherapy (NACT) and definitive surgery.
Interventions:
description: All patients will receive HCQ at a dose of 600 mg orally twice daily. This dose is the same in both phase Ib and phase II portions of the protocol. Capsules of HCQ are available in 200 mg strength, thus patients will initially start with 3 capsules twice daily for a total of 6 capsules per day. HCQ will be administered in divided doses (BID). When taking HCQ twice daily, the two daily doses should be taken 12 hours apart as close to 9am and 9pm as possible. Patients receiving antacids, sucralfate, cholestyramine, and/or bicarbonate should have the HCQ drug dose administered at least 1 hour before or 2 hours after these medications. Hydroxychloroquine will be obtained from the UPENN Investigational Drug Service (IDS).
name: Hydroxychloroquine (HCQ)
type: Drug
description: Gedatolisib will be administered intravenously on a weekly dosing schedule at 150 mg IV.<br/>Within 3 days prior to GED dosing the patient must have an ANC >1.0 x 109/L and platelet count > 75 x 109/L. If hematologic toxicity persists, treatment should be delayed by one week and the complete blood cell count with differential and platelet count repeated. Treatment may be delayed for up to 4 consecutive weeks (28 days). If after 28 days of delay all hematologic toxicity has still not resolved to normal and non-hematologic toxicity has not resolved to <grade 1 then any further treatment with GED should be stopped.
name: Gedatolisib
type: Drug
Study arms:
design_group_description: Patients will receive HCQ, 600 mg BID, for 24 weeks.
design_group_title: Phase II: Arm A
design_group_type: Experimental
design_group_description: Patients will receive HCQ, 600 mg BID, for 24 weeks and GED x 2 weeks administered weekly, as an intravenous dose of 150 mg.
design_group_title: Phase II: Arm B
design_group_type: Experimental
design_group_description: Patients will receive HCQ, 600 mg BID, for 24 weeks and GED x 6 weeks administered weekly, as an intravenous dose of 150 mg.
design_group_title: Phase II: Arm C
design_group_type: Experimental
design_group_description: Patients will receive HCQ, 600 mg BID, for 24 weeks and GED x 12 weeks administered weekly, as an intravenous dose of 150 mg.
design_group_title: Phase II: Arm D
design_group_type: Experimental
design_group_description: Patients will receive HCQ, 600 mg BID, and GED, administered weekly as an intravenous dose of 150 mg, for 6 weeks.
design_group_title: Phase Ib Arm
design_group_type: Experimental
Sponsor: Abramson Cancer Center
Collaborators: Pfizer Inc.
The Breast Cancer Research Foundation
Hoosier Cancer Research Network
Drug name mappings:
name: 硫酸羟氯喹
lang: CN
name: Hydroxychloroquine Sulfate
lang: EN
name: ドロキシクロロキン硫酸塩
lang: JP
name: 吉达利塞
lang: CN
name: Gedatolisib
lang: EN