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-ES
• Lead Sponsor: illy S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-04
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 3580

Inclusion Criteria

•Female 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 for 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 12 weeks of completion of last non endocrine treatment
•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 8 weeks prior to randomization.
•Women regardless of menopausal status.
•Women of reproductive potential must have a negative serum 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
•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 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare invasive disease free survival (IDFS) for patients receiving adjuvant endocrine therapy plus abemaciclib treatment versus adjuvant endocrine therapy alone in HR+, HER2- breast cancer.;Secondary Objective: To evaluate the efficacy, in terms of IDFS, for patients with Ki67 index =20% by central lab<br>To evaluate the efficacy in terms of distant relapse-free survival (DRFS) and overall survival (OS)<br>To assess the safety profile <br>To evaluate the relationship between abemaciclib exposure and clinical (efficacy and safety) outcomes<br>To evaluate health status, general oncology and breast cancer self-reported health related quality of life;Primary end point(s): To compare invasive disease free survival (IDFS) for patients receiving adjuvant endocrine therapy plus abemaciclib treatment versus adjuvant endocrine therapy alone in HR+, HER2- breast cancer.;Timepoint(s) of evaluation of this end point: After approximately 5 years when approximately 345 events have occured.