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Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")

NCT03400254 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2020-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Hydroxychloroquine (HCQ)

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).

DRUG

Gedatolisib

Gedatolisib will be administered intravenously on a weekly dosing schedule at 150 mg IV. 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.

Sponsors & Collaborators

  • Translational Breast Cancer Research Consortium

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Angela DeMichele, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2019-08-30
Completion
2019-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03400254 on ClinicalTrials.gov