Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT04305834
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Hormone Receptor Positive Breast Carcinoma
  • Metastatic Breast Carcinoma
  • Prognostic Stage IV Breast Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Abemaciclib — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.

Key Dates

Start date
Mar 25, 2020
Status verified
Apr 2026
Primary completion
Aug 21, 2026
Completion
Aug 21, 2026

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (abemaciclib)
    Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of grade 3 or higher toxicities [ Time Frame: Up to 30 days post treatment ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Mina Sedrak
[email protected]
626-256-4673
Mina Sedrak (PRINCIPAL_INVESTIGATOR)
City of Hope at Irvine LennarIrvineCalifornia92618
Thanh Nga Doan
[email protected]
6262184673
City of Hope at Long Beach ElmLong BeachCalifornia90813
Thanh Nga Doan
[email protected]
6262184673
City of Hope South PasadenaSouth PasadenaCalifornia91030
Thanh Nga Doan
[email protected]
6262184673
Dana Farber Cancer InstituteBostonMassachusetts02215
Rachel Freedman, MD
[email protected]
617-632-3000
Roswell Park Comprehensive Cancer CenterBuffaloNew York14203
Ellis Levine, MD
[email protected]
1-800-767-9355

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CACity of Hope at Irvine Lennar· Irvine, CACity of Hope at Long Beach Elm· Long Beach, CACity of Hope South Pasadena· South Pasadena, CADana Farber Cancer Institute· Boston, MARoswell Park Comprehensive Cancer Center· Buffalo, NY

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