A study to compare treatment after surgery of abemaciclib combined with standard endocrine therapy versus endocrine therapy alone in patients with early stage breast cancer

Phase 1

• Conditions: ode Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer; MedDRA version: 20.0Level: PTClassification code 10006199Term: Breast cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004362-26-IT
• Lead Sponsor: ELI LILLY & COMPANY, LILLY CORPORATE CENTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5637

Inclusion Criteria

•Female (regardless of menopausal status) or male =18 years of age
•The patient has confirmed HR+, HER2-negative (HER2-), early stage resected invasive breast cancer without evidence of distant metastases.
•The patient must have undergone definitive surgical treatment for the current malignancy.
•The patient must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
•The patient must have high risk of disease recurrence based on nodal status, tumor size, or grade regardless of Ki67 status (Cohort 1), or eligible exclusively based on a Ki67 status (Cohort 2)
•The patient must be randomized within within 16 months from the time of surgery
•If the patient is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 12 weeks following his/her last non-endocrine therapy
(surgery, chemotherapy, or radiation)
•Women of reproductive potential must have a negative blood pregnancy and agree to use highly effective contraceptive methods
•The patient has a ECOG performance status =1

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1790
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1790

Exclusion Criteria

•The patient has Stage IV (M1), Stage IA, and lymph node-negative breast cancer
•Patients with a history of previous breast cancer are excluded, with the exception of LCIS or DCIS treated by locoregional therapy alone =5 years ago. The patient has 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.
•Females who are pregnant or lactating
•The patient has previously received treatment with any CDK4 and CDK6 inhibitor.
•The patient is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills or hormone replacement therapy).
•The patient has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified