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-FI
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-27
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• 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 surgery of the primary breast tumor(s).
•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 Ki-67 status (Cohort 1), or eligible exclusively based on a Ki-67 status (Cohort 2)
•The patient must be randomized within 16 months from the time of definitive breast cancer surgery
•If the patient is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation), whichever is last.;
•Women of reproductive potential must have a negative blood pregnancy test 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 2290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2290

Exclusion Criteria

•The patient has metastatic disease (including contralateral axillary lymph nodes) or lymph node-negative breast cancer. Patients with inflammatory breast cancer are excluded.
•Patients with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone =5 years ago. Patients with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Patients 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 from the date of randomization are excluded.
•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