Spots Global Cancer Trial Database for TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
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Trial Identification
Brief Title: TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
Official Title: The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer
Study ID: NCT06001762
Study Description
Brief Summary: In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. The names of the study drugs involved in this study are: * Abemaciclib (CDK4 and CDK6 inhibitor) * Tamoxifen (Selective estrogen receptor modulator) * Anastrozole/Letrozole (Non-steroidal aromatase inhibitors) * Exemestane (steroidal aromatase inhibitor) * LHRH (Gonadotropin-releasing hormone agonist, or Luteinizing hormone-releasing hormone agonist)
Detailed Description: This research study is a prospective, single-arm, open label, phase 2 study designed to evaluate if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage high-risk hormone receptor positive breast cancer. This research study involves adjuvant abemaciclib plus endocrine (anti-hormone) therapy that works to target breast cancer. Adjuvant therapy is treatment given after surgery, chemotherapy, and/or radiation therapy. The U.S. Food and Drug Administration (FDA) has approved abemaciclib as a treatment option for early-stage high-risk hormone receptor breast cancer. The FDA has also approved hormonal therapies as treatment for hormone receptor positive breast cancer. The research study procedures include screening for eligibility, study treatment including laboratory evaluations and questionnaires, blood tests, tumor biopsies, and stool collections. Participation in this research study is expected to last for at least 2 years and up to 5 years. It is expected that about 90 people will take part in this research study. Eli Lilly and Company is supporting this study by providing funding for the study and supplying the study drug, abemaciclib.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Stamford Hospital, Stamford, Connecticut, United States
New England Cancer Specialists, Scarborough, Maine, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Dana-Farber Cancer Institute at Steward St. Elizabeth's, Brighton, Massachusetts, United States
Dana-Farber Cancer Institute at Foxborough, Foxboro, Massachusetts, United States
Dana-Farber Cancer Institute at Merrimack Valley, Methuen, Massachusetts, United States
Dana-Farber Cancer Institute at Milford, Milford, Massachusetts, United States
Dana-Farber Cancer Institute at South Shore, South Weymouth, Massachusetts, United States
Dana-Farber Cancer Insitute at Londonderry Hospital, Londonderry, New Hampshire, United States
Contact Details
Name: Erica Mayer, MD, MPH
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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