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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Official Title

A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Keywords

Breast Cancer early stage breast cancer cyclin-dependent kinase (CDK) Breast Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
  • The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
  • The participant must have undergone definitive surgical treatment for the current malignancy.
  • The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
  • The participant must have axillary lymph node involvement by tumor and have one of the following indicating a higher risk of relapse:
  • 4 or more axillary lymph nodes involved with cancer
  • Tumor size of at least 5 centimeters
  • Grade 3 histology
  • Ki67 index by central analysis of ≥20% on untreated breast tissue
  • The participant must be randomized within 16 months from the time of surgery.
  • If the participant is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 12 weeks of adjuvant endocrine therapy following his/her last non-endocrine therapy (surgery,chemotherapy, or radiation).
  • Participants must have recovered from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
  • Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
  • The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • The participant has adequate organ function.
  • The participant is able to swallow oral medications.

You CAN'T join if...

  • Stage IV (M1), Stage IA, and lymph node negative breast cancer.
  • Participants with a history of previous breast cancer are excluded, with the exception of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years are excluded.
  • Females who are pregnant or lactating.
  • The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
  • The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
  • The participant has previously received endocrine therapy for breast cancer prevention(tamoxifen or raloxifene or aromatase inhibitors).
  • The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
  • The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE) (for example, deep vein thrombosis [DVT] of the leg or arm and/or pulmonary embolism) will be excluded.
  • The participant has active bacterial infection, fungal infection, or detectable viral infection or viral load.
  • The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.

Locations

  • Univ of California San Francisco not yet accepting patients
    San Francisco, California, 94115, United States
  • California Cancer Associates Research and Excellence (cCARE) not yet accepting patients
    Fresno, California, 93720, United States
  • Kaiser Permanente not yet accepting patients
    Vallejo, California, 94589, United States
  • Dignity Health Dominican Oncology and Hematology not yet accepting patients
    Santa Cruz, California, 95065, United States
  • University of California, Davis - Health Systems not yet accepting patients
    Sacramento, California, 95817, United States
  • Pacific Cancer Care not yet accepting patients
    Monterey, California, 93940, United States
  • Cancer Center of Santa Barbara with Sansum Clinic accepting new patients
    Santa Barbara, California, 93105, United States
  • Providence St. Joseph's Medical Center not yet accepting patients
    Burbank, California, 91505, United States
  • Beverly Hills Cancer Center accepting new patients
    Beverly Hills, California, 90211, United States
  • Loma Linda University School of Medicine not yet accepting patients
    Loma Linda, California, 92354, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
Click here for more information about this study: A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer (monarchE)
ID
NCT03155997
Phase
Phase 3
Study Type
Interventional
Last Updated
November 22, 2017
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