Breast CancerRESONATENCT07363434
A Real-world Study of Indian Patients With Advanced Breast Cancer Treated With Ribociclib
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2022to 26 Jul 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This study included HR+/HER2- aBC patients who received ribociclib in combination with ET in India.
Who may be able to join
- Women ≥18 years old diagnosed with HR+ and HER2- aBC who received at least one dose of ribociclib in combination with ET following the approved indication, with at least one follow-up visit after diagnosis or death due to any cause.
Who cannot join
- Patients with prior/current enrollment in an interventional clinical trial for aBC/metastatic breast cancer and those who had received another cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor in any setting.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RESONATE Study: Real-world Outcomes With Ribociclib in Indian Patients With HR+, HER2- Advanced Breast Cancer
The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC).
This study used secondary data sources, i.e., paper-based records; electronic medical records (EMRs); and other sources, such as radiology reports, pathology reports, and examination/clinician notes related to aBC, from clinics/hospitals across 18 sites in India. Aggregated data of anonymized patients treated with ribociclib plus endocrine therapy (ET) by the approved indication between June 2018 and December 2021 were collected and analyzed.
- Conditions
- Breast Cancer
- Keywords
- Ribociclib, Endocrine therapy, Metastasis, Progression-free survival
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib Group | Indian women with a confirmed diagnosis of HR+, HER2- aBC who were treated with ribociclib in combination with ET. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Progression-free Survival (rwPFS) for the Entire Patient Group
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
Measured: Up to approximately 42 months
rwPFS by Line of Therapy for the Entire Patient Group
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
Measured: Up to approximately 42 months
Duration of Clinical Response by Type of Clinical Response and Line of Therapy for the Entire Patient Group
Clinical response categories included complete response, any response (other than complete response), no response, and any progression.
Measured: Up to approximately 42 months
Number of Patients by Type of Clinical Response and Line of Therapy for the Entire Patient Group
Clinical response categories included complete response, any response (other than complete response), no response, and any progression.
Measured: Up to approximately 42 months
Secondary outcomes (10)
rwPFS for Patients With at Least 6 Months of Follow-up
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
Measured: Up to approximately 42 months
rwPFS by Line of Therapy for Patients With at Least 6 Months of Follow-up
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
Measured: Up to approximately 42 months
Duration of Clinical Response by Type of Clinical Response and Line of Therapy for Patients With at Least 6 Months of Follow-up
Clinical response categories included complete response, any response (other than complete response), no response, and any progression.
Measured: Up to approximately 42 months
Number of Patients With Adverse Events
Measured: Up to approximately 42 months
Number of Adverse Events
Measured: Up to approximately 42 months
Number of Adverse Events by Severity
Measured: Up to approximately 42 months
Number of Patients who Discontinued Treatment by Reason for Discontinuation
Measured: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Discontinuation
Measured: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Interruptions
Measured: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Reduction
Measured: Up to approximately 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start21 Dec 2022
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
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
- 335 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
- NCT07363434
- Sponsor's protocol ID
- CLEE011AIN01
- Acronym
- RESONATE
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESONATE Study: Real-world Outcomes With Ribociclib in Indian Patients With HR+, HER2- Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07363434
- Acronym / sponsor ID
- RESONATE / CLEE011AIN01
- Conditions
- Breast Cancer
- Keywords
- Ribociclib, Endocrine therapy, Metastasis, Progression-free survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 23 Jan 2026 (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.
The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC).
This study used secondary data sources, i.e., paper-based records; electronic medical records (EMRs); and other sources, such as radiology reports, pathology reports, and examination/clinician notes related to aBC, from clinics/hospitals across 18 sites in India. Aggregated data of anonymized patients treated with ribociclib plus endocrine therapy (ET) by the approved indication between June 2018 and December 2021 were collected and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribociclib Group | – | –Indian women with a confirmed diagnosis of HR+, HER2- aBC who were treated with ribociclib in combination with ET. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included HR+/HER2- aBC patients who received ribociclib in combination with ET in India.
Key inclusion criteria (1 listed)
- Women ≥18 years old diagnosed with HR+ and HER2- aBC who received at least one dose of ribociclib in combination with ET following the approved indication, with at least one follow-up visit after diagnosis or death due to any cause.
Key exclusion criteria (1 listed)
- Patients with prior/current enrollment in an interventional clinical trial for aBC/metastatic breast cancer and those who had received another cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor in any setting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-world Progression-free Survival (rwPFS) for the Entire Patient Group
Time frame: Up to approximately 42 months
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
rwPFS by Line of Therapy for the Entire Patient Group
Time frame: Up to approximately 42 months
rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
Duration of Clinical Response by Type of Clinical Response and Line of Therapy for the Entire Patient Group
Time frame: Up to approximately 42 months
Clinical response categories included complete response, any response (other than complete response), no response, and any progression.
Number of Patients by Type of Clinical Response and Line of Therapy for the Entire Patient Group
Time frame: Up to approximately 42 months
Clinical response categories included complete response, any response (other than complete response), no response, and any progression.
10 secondary outcomes
rwPFS for Patients With at Least 6 Months of Follow-up
Time frame: Up to approximately 42 months
rwPFS by Line of Therapy for Patients With at Least 6 Months of Follow-up
Time frame: Up to approximately 42 months
Duration of Clinical Response by Type of Clinical Response and Line of Therapy for Patients With at Least 6 Months of Follow-up
Time frame: Up to approximately 42 months
Number of Patients With Adverse Events
Time frame: Up to approximately 42 months
Number of Adverse Events
Time frame: Up to approximately 42 months
Number of Adverse Events by Severity
Time frame: Up to approximately 42 months
Number of Patients who Discontinued Treatment by Reason for Discontinuation
Time frame: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Discontinuation
Time frame: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Interruptions
Time frame: Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Reduction
Time frame: Up to approximately 42 months
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 23 Jan 2026.
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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 United States.
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 1 inclusion and 1 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 23 Jan 2026. 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 United States. 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?
Real-world Progression-free Survival (rwPFS) for the Entire Patient Group (time frame: Up to approximately 42 months). The study lists 4 primary outcomes in all. 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 23 Jan 2026.