NCT05569187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

October 4, 2022

Last Update Submit

November 7, 2022

Conditions

Breast Cancer

Keywords

HR+/HER2-,advanced breast cancer,ribociclib,non-steroidal aromatase inhibitors,first-line treatment

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients alive and progression-free from disease at 1 year

    The purpose was to evaluate the effectiveness of first-line ribociclib in combination with non-steroidal aromatase inhibitors in a Brazilian female population diagnosed with HR+/HER2- locally advanced or metastatic BC. Effectiveness was measured by the proportion of patients alive and free of disease progression at 1 year.

    1 year post-treatment

Secondary Outcomes (11)

  • Proportion of patients alive and progression-free from disease at 6 months

    6 months post-treatment

  • Proportion of patients who had disease progression at 6 months

    6 months post-treatment

  • Proportion of patients who had disease progression at 1 year

    1 year post-treatment

  • Proportion of patients who died at 6 months

    6 months post-treatment

  • Proportion of patients who died at 1 year

    1 year post-treatment

  • +6 more secondary outcomes

Study Arms (1)

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

Drug: Ribociclib

Interventions

RibociclibDRUG

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

Ribociclib in combination with non-steroidal aromatase inhibitors

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study included women with HR+/HER2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population was composed only of women aged 18 years or older.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Uncontrolled heart disease and/or clinically significant cardiac repolarization abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

São Paulo, São Paulo, 01317 000, Brazil

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2022

First Posted

October 6, 2022

Study Start

March 23, 2021

Primary Completion

October 29, 2021

Study Completion

October 29, 2021

Last Updated

November 8, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)