Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.

NCT04305834 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 19206NCI-2019-08847P30CA033572
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of grade 3 or higher toxicities

  Adverse events will be characterized using the descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v). 5.0.

  Up to 30 days post treatment

Secondary Outcomes (16)

• Incidence of toxicities

  Up to 30 days post treatment

• Incidence of toxicities

  Up to cycle 6

• Dose reductions

  Up to cycle 6

• Dose holds

  Up to 30 days post treatment

• Treatment discontinuations due to factors other than progression

  Up to 30 days post treatment

Other Outcomes (3)

• Biological age via deoxyribonucleic acid (DNA) methylation level

  Up to 2 years post treatment

• Genome-wide methylome and transcriptome analyses

  Up to 2 years post treatment

• Incidence of toxicities at least possibly attributable to agent

  Up to 2 years post treatment

Study Arms (1)

Treatment (abemaciclib)

EXPERIMENTAL

Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Abemaciclib; Other: Questionnaire Administration

Interventions

Abemaciclib DRUG

Given PO

Also known as: LY-2835219, LY2835219, Verzenio

Treatment (abemaciclib)

Questionnaire Administration OTHER

Ancillary studies

Treatment (abemaciclib)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Documented informed consent of the participant
• Age \>= 70 years
• Life expectancy \> 6 months
• Ability to read and understand English or Spanish
• Measurable or non-measurable disease
• Histologically or cytologically confirmed diagnosis of:
• Estrogen-receptor positive and/or progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods according to the local institution standard protocol
• HER2-negative breast cancer defined as negative if the IHC status is 0 or 1+, or if IHC is 2+ and in situ hybridization assay is negative per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
• Radiographically confirmed metastatic breast cancer
• Progressed on prior endocrine therapy or palbociclib or ribociclib or chemotherapy
• Patients who received chemotherapy recovered from the acute side effects to prior cancer therapy (except alopecia or residual grade 2 peripheral neuropathy) to =\< grade 1 or baseline. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy)
• Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization
• Absence of central nervous system (CNS) involvement unless they meet ONE of the following criteria:
• Untreated brain metastases (e.g., lesions \< 1 cm) not needing immediate local therapy
• Previously treated brain metastases not needing immediate local therapy

You may not qualify if:

• Major surgery within 14 days prior to receiving study drug or has not recovered from major side effect
• Patient is currently receiving any of the prohibited medications detailed below and cannot be discontinued 7 days prior to starting study drug
• Other investigational therapy should be given to participants
• Anticancer agents other than the study medications administered as part of this study protocol should be given to participants. If such agents are required for a participant then the participant must first be withdrawn from the study
• Co-medication that may interfere with study results; e.g. immune-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrolimus are prohibited during the treatment phase of the study, unless discussed with principal investigator felt to be of low clinical risk to the participant
• Use of herbal medications may have unknown interactions with the metabolism of the study agents, and therefore are prohibited from use during the treatment phase of the trial
• Known hypersensitivity to any of the excipients of abemaciclib
• Active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive). Screening is not required for enrollment
• Impairment of gastrointestinal (GI) function or GI disease that in the investigator's opinion may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
• Patient has any other concurrent severe or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis)
• Inability to swallow oral medications
• Serious or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \[e.g. estimated creatinine clearance \< 30 ml/min\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)
• History of non-compliance to medical regimen
• Patients with a prior malignancy diagnosed within 2 years and with evidence of disease (except adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

City of Hope at Long Beach Elm

Long Beach, California, 90813, United States

RECRUITING

City of Hope South Pasadena

South Pasadena, California, 91030, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joanne Mortimer, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joanne Mortimer, MD

CONTACT

626-359-8111; jmortimer@coh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 12, 2020
• Study Start: March 25, 2020
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): August 21, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (6)