A Study Investigating the Impact of Food on Tolerability of Abemaciclib for Patients with Metastatic Breast Cancer

Phase 1

• Conditions: Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-001853-28-ES
• Lead Sponsor: illy S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-07
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Have a diagnosis of HR+, HER2- mBC
Have all of the following:
•Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
•Prior treatment with chemotherapy for locally advanced or metastatic disease.
•No prior treatment with CDK4 and CDK6 inhibitor.

Have a performance status (PS) of =1 on the Eastern Cooperative Oncology Group (ECOG) scale (Oken et al. 1982)

Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures, including keeping records in the electronic patient diary (e-diary) as required by study protocol.

Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy. All patients who experienced diarrhea as a side effect of previous therapy must have recovered to =Grade 1 prior to enrollment.
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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
are currently receiving treatment in a clinical study involving an investigational product or are enrolled into any other type of medical research judged not to be scientifically or medically compatible with this study.
have a serious concomitant systemic disorder (for example, active infection or a GI disorder causing clinically significant symptoms such as nausea, vomiting or diarrhea [such as Crohn’s disease, ulcerative colitis], or profound immune suppression) or a serious preexisting medical condition (for example, history of major surgical resection involving the stomach or small bowel) that, in the opinion of the investigator, would compromise/preclude the patient’s ability to adhere to the protocol.

Study & Design

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