While adjuvant endocrine therapy (ET) is effective in reducing risk of recurrence in patients with hormone receptor (HR)-positive early breast cancer (EBC), recurrences are still common, especially in patients with unfavorable clinical, pathological and/or molecular features. Ribociclib, a CDK4/6 inhibitor, demonstrated clinical efficacy with tolerable toxicity when added to ET in patients with HR-positive, HER2-negative advanced breast cancer.

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The purpose of this study is to evaluate the preliminary safety and tolerability of ribociclib to standard adjuvant ET in patients with HR+, HER2- high-risk EBC. Stolpi zemli 2 sezon torrent gratis. Layout table for study information Study Type: Interventional (Clinical Trial) Actual Enrollment: 52 participants Intervention Model: Single Group Assignment Intervention Model Description: The trial used to be a parallel design, it has been amended to a single arm trial. Masking: None (Open Label) Primary Purpose: Treatment Official Title: An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer Actual Study Start Date: June 20, 2017 Estimated Primary Completion Date: March 25, 2020 Estimated Study Completion Date: March 25, 2020. Hortobagyi GN, Connolly JL, D'Orsi CJ, et al (2017). From AJCC Cancer Staging Manual 8th ed.

By Amin MB, Edge S, Greene FL, et al. Springer Layout table for additonal information Responsible Party: Novartis Pharmaceuticals ClinicalTrials.gov Identifier: Other Study ID Numbers: CLEE011G2301 2014-001795-53 ( EudraCT Number ) First Posted: March 13, 2017 Last Update Posted: July 25, 2018 Last Verified: July 2018 Individual Participant Data (IPD) Sharing Statement: Plan to Share IPD: Undecided Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies.

These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the triasl in line with applicable laws and regulations. This trial data will be available according to the process described on www.clinicalstudydatarequest.com. Layout table for additional information Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No Keywords provided by Novartis ( Novartis Pharmaceuticals ).

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