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Completed

NCT Number: NCT05569187

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

Novartis Investigative Site

São Paulo, 01317 000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ribociclib

Drug

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

Primary outcomes

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

    Time frame: 1 year post-treatment

    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.

Secondary outcomes

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

    Time frame: 6 months post-treatment

    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 6 months post-treatment.

  2. Proportion of patients who had disease progression at 6 months

    Time frame: 6 months post-treatment

    The purpose was to evaluate the proportion of patients who had disease progression at 6 months.

  3. Proportion of patients who had disease progression at 1 year

    Time frame: 1 year post-treatment

    The purpose was to evaluate the proportion of patients who had disease progression at 1 year.

  4. Proportion of patients who died at 6 months

    Time frame: 6 months post-treatment

    The purpose was to evaluate the proportion of patients who died at 6 months.

  5. Proportion of patients who died at 1 year

    Time frame: 1 year post-treatment

    The purpose was to evaluate the proportion of patients who died at 1 year.

  6. Proportion and cause of patients who reduced a treatment dose at 6 months

    Time frame: 6 months post-treatment

    Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg)

  7. Proportion and cause of patients who reduced a treatment dose at 1 year

    Time frame: 1 year post-treatment

    Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg)

  8. Frequency of dose interruption and cause, per patient, at 1 year

    Time frame: 1 year post-treatment

    The purpose was to evaluate frequency of dose interruption and cause, per patient, at 1 year.

  9. Adverse Event frequency and classification of the severity degree

    Time frame: throughout the study, approximately 1 year

    Frequency and classification of the degree of severity of the following adverse events of interest: neutropenia, febrile neutropenia, increased QT interval (> 60 ms,> 480ms ≤ 500 ms, and> 500 ms), AST/ALT elevation three times greater than upper limit. In relation to the adverse events of interest, they were classified regarding the severity, graded from 1 to 4, corresponding to mild, moderate, severe and life-threatening, or as described in the medical record.

  10. Pattern of the treatment of AE of interest at 6 months

    Time frame: 6 months post-treatment

    Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated.

  11. Pattern of the treatment of AE of interest at 12 months

    Time frame: 12 months post-treatment

    Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

An Observational, Retrospective, Multicenter, National Study of the Effectiveness of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in First-line Treatment of Brazilian Patients With HR+/HER2- Advanced Breast Cancer

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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