ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT04523857
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Oral CDK4/6 inhibitor to target bone marrow disseminated tumor cells (DTCs)
  • Hydroxychloroquine — DRUG
    Oral autophagy inhibitor to target bone marrow disseminated tumor cells (DTCs)

Study Details

This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled. The drugs being studied are hydroxychloroquine (Plaquenil) and abemaciclib (also Verzenio). This research study is testing whether using these drugs to target the disseminated tumor cells in bone marrow can reduce their number or eliminate them. Both hydroxychloroquine and abemaciclib are pills that will be taken twice daily. Both are approved by the FDA

Key Dates

Start date
Nov 1, 2021
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: A (Abema)
    Abemaciclib (150 mg BID)
  • Experimental: B (Abema + HCQ)
    Abemaciclib (100 mg or 150 mg BID\*) + Hydroxychloroquine (600 mg BID) \*Abemaciclib dose will be determined by safety cohort

Primary Outcome Measure

Incidence of treatment-emergent adverse events during cycle 1 of the safety cohort (safety of combination HCQ + Abema) [ Time Frame: Toxicity is assessed over the first cycle (4 weeks) of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Lauren Bayne, PhD
[email protected]
215-615-2367
Amy Clark, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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