Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Description

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

Conditions

Early Breast Cancer

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Study Overview

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Study Details

Study overview

The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).

A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Condition
Early Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Anchorage

Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States, 99508

Savannah

Summit Cancer Care PC, Savannah, Georgia, United States, 31405

Hinsdale

Hope And Healing Care, Hinsdale, Illinois, United States, 60521

Baltimore

Mercy Medical Center, Baltimore, Maryland, United States, 21202

Jackson

Jackson Oncology Associates, Jackson, Mississippi, United States, 39202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC).
  • * Participant has HER2-negative breast cancer.
  • * Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.
  • * Participant has no contraindication to receive adjuvant ET in the study.
  • * Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:
  • * Anatomic Stage Group III, or
  • * Anatomic Stage Group IIB, or
  • * A subset of Anatomic Stage Group IIA
  • * Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
  • * Participant has adequate bone marrow and organ function.
  • * ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:
  • * QTcF interval at Screening \< 450 msec (QT interval using Fridericia's correction).
  • * Mean resting heart rate 50-99 beats per minute (determined from the ECG).
  • * Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
  • * Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.
  • * Participant has any other concurrent severe and/or uncontrolled medical condition.
  • * Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
  • * Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2030-09-20