Breast CancerNCT05569187
Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ribociclib
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Mar 2021to 29 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population was composed only of women aged 18 years or older.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- Ribociclib
- Keywords
- HR+/HER2-,, advanced breast cancer,, ribociclib,, non-steroidal aromatase inhibitors,, first-line treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibociclibDrug
Included patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post-treatment
Secondary outcomes (11)
Proportion of patients alive and progression-free from disease at 6 months
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.
Measured: 6 months post-treatment
Proportion of patients who had disease progression at 6 months
The purpose was to evaluate the proportion of patients who had disease progression at 6 months.
Measured: 6 months post-treatment
Proportion of patients who had disease progression at 1 year
The purpose was to evaluate the proportion of patients who had disease progression at 1 year.
Measured: 1 year post-treatment
Proportion of patients who died at 6 months
The purpose was to evaluate the proportion of patients who died at 6 months.
Measured: 6 months post-treatment
Proportion of patients who died at 1 year
The purpose was to evaluate the proportion of patients who died at 1 year.
Measured: 1 year post-treatment
Proportion and cause of patients who reduced a treatment dose at 6 months
Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg)
Measured: 6 months post-treatment
Proportion and cause of patients who reduced a treatment dose at 1 year
Patients who reduced a treatment dose (from 600 mg to 400 mg or from 400 mg to 200 mg)
Measured: 1 year post-treatment
Frequency of dose interruption and cause, per patient, at 1 year
The purpose was to evaluate frequency of dose interruption and cause, per patient, at 1 year.
Measured: 1 year post-treatment
Adverse Event frequency and classification of the severity degree
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.
Measured: throughout the study, approximately 1 year
Pattern of the treatment of AE of interest at 6 months
Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated.
Measured: 6 months post-treatment
Pattern of the treatment of AE of interest at 12 months
Pattern of the treatment of AE of interest were reported to evaluate how the patients with AE of interest were treated.
Measured: 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start23 Mar 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569187
- Sponsor's protocol ID
- CLEE011ABR02
- Status last verified
- Nov 2022
- First submitted
- 4 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05569187
- Acronym / sponsor ID
- CLEE011ABR02
- Conditions
- Breast Cancer
- Keywords
- HR+/HER2-,, advanced breast cancer,, ribociclib,, non-steroidal aromatase inhibitors,, first-line treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribociclib in combination with non-steroidal aromatase inhibitors | – | Drug: RibociclibIncluded patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population was composed only of women aged 18 years or older.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibociclibIncluded patients who received doses (600 mg, 400 mg, and 200 mg) at 6 months and 1 year | Drug | Ribociclib in combination with non-steroidal aromatase inhibitors |
Primary outcome
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.
11 secondary outcomes
Proportion of patients alive and progression-free from disease at 6 months
Time frame: 6 months post-treatment
Proportion of patients who had disease progression at 6 months
Time frame: 6 months post-treatment
Proportion of patients who had disease progression at 1 year
Time frame: 1 year post-treatment
Proportion of patients who died at 6 months
Time frame: 6 months post-treatment
Proportion of patients who died at 1 year
Time frame: 1 year post-treatment
Proportion and cause of patients who reduced a treatment dose at 6 months
Time frame: 6 months post-treatment
Proportion and cause of patients who reduced a treatment dose at 1 year
Time frame: 1 year post-treatment
Frequency of dose interruption and cause, per patient, at 1 year
Time frame: 1 year post-treatment
Adverse Event frequency and classification of the severity degree
Time frame: throughout the study, approximately 1 year
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 at 12 months
Time frame: 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Results for CLEE011ABR02 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients alive and progression-free from disease at 1 year (time frame: 1 year post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.