Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer

NCT ID: NCT05569187

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-23
• Study Completion Date: 2021-10-29

Brief Summary

Observational, longitudinal (retrospective cohort), multicenter, national study aiming to evaluate the proportion of women with HR+/HER2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors who were alive and without disease progression at 1 year.

Detailed Description

The study was conducted in 11 Brazilian sites specialized in the treatment of this condition. The study data were collected from the review of medical records by the Investigator (or designated).

The sites must have had adequate medical records to ensure robust medical record review. Therefore, a feasibility assessment was carried out at potential site prior to the study implementation to assess the adequacy of medical records and the data routinely available.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Ribociclib in combination with non-steroidal aromatase inhibitors

Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year

Ribociclib

Intervention Type: DRUG

Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year

Interventions

Ribociclib

Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female patient ≥ 18 years of age. All the patients must have at least one year of follow-up
• Patients at an age not consistent with postmenopausal status could only participate if they had oophorectomy surgery or being on treatment with goserelin for ovarian suppression Post-menopausal women defined as age ≥ 60 years old or < 60 years old and amenorrhea for 12 months or more (in the absence of chemotherapy, tamoxifen, toremifene or goserelin use for ovarian suppression)
• Confirmed diagnosis of HR+/HER2- locally advanced or metastatic BC
• Never in use of CDK 4/6i

Exclusion Criteria

• Patients in menopause status other than postmenopausal (young patients must have undergone oophorectomy being on treatment with goserelin for ovarian suppression to be characterized as postmenopausal)
• Previous use, at any time, of CDK 4/6i
• The patient received any previous systemic therapy for advanced breast cancer Patients who have received (neo)adjuvant therapy for breast cancer are eligible. If previous (neo) adjuvant therapy has included letrozole or anastrozole, the disease- free interval should be longer than 12 months from completion of treatment until entry in this trial Patients who received ≤28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible
• Uncontrolled heart disease and/or clinically significant cardiac repolarization abnormalities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Countries

Brazil

Related Links

http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17980

Results for CLEE011ABR02 from the Novartis Clinical Trials Website

Other Identifiers

CLEE011ABR02

Identifier Type: -

Identifier Source: org_study_id