A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer

Phase 4

Withdrawn

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Abemaciclib; Drug: Nonsteroidal Aromatase Inhibitor (NSAI)

• Registration Number: NCT03988114
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-17
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06
• Study Start: 2019-09-16
• Primary Completion: 2022-03-23
• Study Completion: 2023-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis

• Participants must have 1 or more of the following:

  • A high grade tumor in tissue
  • Negative progesterone receptor (PR) status
  • Have cancer that has spread to the liver
  • Have a treatment-free interval (TFI) <36 months

• Participants must have HR+, HER2- breast cancer

• Participants must have adequate organ function

Exclusion Criteria

• Participants must not have cancer that has spread to other organs that has severely affected their function
• Participants must not have cancer that has spread to the brain that is unstable or untreated
• Participants must not have received endocrine therapy in the metastatic setting
• Participants must not have known active infection
• Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment
• Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 & 6 inhibitor or everolimus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abemaciclib + NSAI	Nonsteroidal Aromatase Inhibitor (NSAI)	Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
Abemaciclib + NSAI	Abemaciclib	Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months)	PFS
Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)	Baseline to Objective Disease Progression (Estimated up to 26 Months)	ORR

Secondary Outcome Measures

Name	Time	Method
Duration of Response (DoR)	Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months)	DoR
Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD)	Baseline to Objective Disease Progression (Estimated up to 26 Months)	DCR
Clinical Benefit Rate (CBR): Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months	Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months)	CBR
Time to Response (TTR)	Baseline to Date of CR or PR (Estimated up to 26 Months)	TTR

Trial Locations

Locations (115)

Southern Cancer Center, P.C.; 🇺🇸 Daphne, Alabama, United States

Arizona Oncology Associates, P.C.; 🇺🇸 Tempe, Arizona, United States

Compassionate Cancer Care Medical Group Inc; 🇺🇸 Fountain Valley, California, United States

California Cancer Associates Research and Excellence (cCARE); 🇺🇸 Fresno, California, United States

Beaver Medical Group; 🇺🇸 Highland, California, United States

Pacific Cancer Care; 🇺🇸 Monterey, California, United States

St. Joseph Hospital; 🇺🇸 Orange, California, United States

Comprehensive Cancer Centers of the Desert; 🇺🇸 Palm Springs, California, United States

California Cancer Associates in Research and Excellence; 🇺🇸 San Marcos, California, United States

Cancer Center of Santa Barbara with Sansum Clinic; 🇺🇸 Santa Barbara, California, United States

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