HR+/HER2- Early Breast CancerNISLEESANCT06797531
RWE Non-Interventional Prospective Study of Ribociclib Effectiveness and Safety in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
An observational study of HR+/HER2- Early Breast Cancer, run by Novartis Pharmaceuticals at 2 sites in Saudi Arabia.
Trial summary
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal and postmenopausal women, or men in… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- HR+/HER2- Early Breast Cancer
- What is being tested?
- ribociclib
- How many people
- 177 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 27 Aug 2025to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HR+/HER2- early breast cancer in premenopausal, perimenopausal, and postmenopausal women or men in Saudi Arabia.
Who may be able to join
- Signed and dated Patient Informed Consent Form (PICF) obtained.
- The patient is ≥ 18 years-old at the time of PICF signature.
- Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive BC.
- Male or female patients with HER2- BC.
- Patients who are currently receiving ribociclib in combination with adjuvant ET as per approved local label for up to 6 months prior the enrollment date.
- Male or female patients with American Joint Committee on Cancer (AJCC) Anatomic Stage Group IIA(subset) /IIB or Anatomic Stage Group III EBC.
- Female patients with known menopausal status (at the time of PICF signature or initiation of adjuvant ET, whichever occurs earlier), or male.
Who cannot join
- Ribociclib-based treatment regimen beyond adjuvant therapy for EBC.
- Patients are currently participating in any other clinical trials.
- Patients who previously received any other CDK4/6 inhibitor.
- Patients who refused to sign informed consent.
- According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reason.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Saudi Arabia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Riyadh, 11211
- Recruiting
Novartis Investigative Site
Riyadh, 11426
About this study
Official title: Real-world Evidence Non-Interventional proSpective Study of kisqaLi (Ribociclib) Effectiveness and safEty in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal and postmenopausal women, or men in Saudi Arabia.
Read the detailed description
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal, and postmenopausal women or men in Saudi Arabia.
The study aims to recruit 177 patients who have been newly receiving ribociclib for up to 6 months prior to enrollment date, as per the locally approved label to which the physician has made an independent decision to prescribe ribociclib. Patients will be enrolled over a recruitment window of 9 months and will be followed up for 36 months to assess the study outcomes. It is planned to capture data at the following timepoints (+/- 1 month): Baseline, 3, 6, 12, 24, and 36 months. This is in line with the frequency of routine follow-up visits, per standard of care.
Data will be collected from patients' electronic medical records in the selected sites. The planned number of sites is 6, to be selected based on feasibility reports, considering the patient pool and research capabilities.
Participating sites' investigators will review all the available clinical files of patients whose ribociclib treatment decision has been made by their treating physician and will invite those who fulfill the eligibility criteria to participate in the study. Data will be entered into an electronic case report form (eCRF). All patients' data will remain anonymized, fulfilling the requirements of data protection. Data collected will include information on previous treatments received, disease history, and current treatment patterns and outcomes.
Participation in the study is not intended to change the routine treatment patients receive as determined by their treating physicians; all therapeutic decisions, as well as the type and timing of disease monitoring, will be at the discretion of the treating physician.
- Conditions
- HR+/HER2- Early Breast Cancer
- Being tested
- ribociclib
- Keywords
- Early breast cancer, Saudi Arabia, Ribociclib, Effectiveness, Safety, Real world evidence, RWE, Observational study
- 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
This is an observational study. There is no treatment allocation. The decision to initiate ribociclib will be based solely on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| Ribocliclib | HR+/HER2- early breast cancer patients who have been newly receiving ribociclib for up to 6 months prior to enrollment Receives: Drug: ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Breast Cancer-Free Survival (iBCFS)
iBCFS, defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or invasive contralateral BC.
iBCFS will be assessed using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant BC Clinical Trials), as assessed by the investigator, in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB/III EBC.
Measured: 36 months
Secondary outcomes (10)
Invasive disease free survival (iDFS)
iDFS is a composite endpoint that contains invasive Ipsilateral Breast Tumor Recurrence (IBTR), loco-regional invasive recurrence, distant recurrence, death from BC, death from non-BC cause, death from unknown cause, invasive contralateral BC and second primary invasive cancer (non-breast) in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB//III EBC.
Measured: Up to 36 months
Distant disease free survival (DDFS)
DDFS defined as distant recurrence, death from BC, death from non-BC cause, death from unknown cause and second primary invasive cancer (non-breast) in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB/III EBC.
Measured: Up to 36 months
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency and severity of AEs and SAEs including laboratory findings, AST/ALT elevations and ECG abnormalities qualifying and reported as AEs.
Measured: 36 months
Change from baseline in the physical functioning sub-scale score and global health status/QoL scale score as assessed by EORTC QLQ-C30
European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (EORTC QLQ-C30) incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measured: 36 months
Demographics - Age
Age at baseline (years)
Measured: Baseline
Demographics - Gender, race, region
Number of participants per gender, race and region
Measured: Baseline
Clinical characteristics - menopausal status
Assessment of menopausal status
Measured: Baseline up to 36 months
Clinical characteristics - anatomical stage
Assessment of anatomical stage (IIa/IIb/III) according to American Joint Committee on Cancer (AJCC)
Measured: Baseline up to 36 months
Clinical characteristics - pre-index chemotherapy and concomitant medication
Assessment of pre-index chemotherapy and concomitant medications
Measured: Baseline up to 36 months
Clinical characteristics - medical history
Assessment of medical history
Measured: Baseline up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start27 Aug 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Early 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
- Prospective
- Enrolment
- 177 participants (estimated)
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
- NCT06797531
- Sponsor's protocol ID
- CLEE011ASA01
- Acronym
- NISLEESA
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evidence Non-Interventional proSpective Study of kisqaLi (Ribociclib) Effectiveness and safEty in Patients With HR+/HER2- Early Breast Cancer in Saudi Arabia
- ClinicalTrials.gov ID
- NCT06797531
- Acronym / sponsor ID
- NISLEESA / CLEE011ASA01
- Conditions
- HR+/HER2- Early Breast Cancer
- Keywords
- Early breast cancer, Saudi Arabia, Ribociclib, Effectiveness, Safety, Real world evidence, RWE, Observational study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 28 Jan 2025 (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.
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal and postmenopausal women, or men in Saudi Arabia.
Detailed description
This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal, and postmenopausal women or men in Saudi Arabia.
The study aims to recruit 177 patients who have been newly receiving ribociclib for up to 6 months prior to enrollment date, as per the locally approved label to which the physician has made an independent decision to prescribe ribociclib. Patients will be enrolled over a recruitment window of 9 months and will be followed up for 36 months to assess the study outcomes. It is planned to capture data at the following timepoints (+/- 1 month): Baseline, 3, 6, 12, 24, and 36 months. This is in line with the frequency of routine follow-up visits, per standard of care.
Data will be collected from patients' electronic medical records in the selected sites. The planned number of sites is 6, to be selected based on feasibility reports, considering the patient pool and research capabilities.
Participating sites' investigators will review all the available clinical files of patients whose ribociclib treatment decision has been made by their treating physician and will invite those who fulfill the eligibility criteria to participate in the study. Data will be entered into an electronic case report form (eCRF). All patients' data will remain anonymized, fulfilling the requirements of data protection. Data collected will include information on previous treatments received, disease history, and current treatment patterns and outcomes.
Participation in the study is not intended to change the routine treatment patients receive as determined by their treating physicians; all therapeutic decisions, as well as the type and timing of disease monitoring, will be at the discretion of the treating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribocliclib | – | Drug: ribociclibHR+/HER2- early breast cancer patients who have been newly receiving ribociclib for up to 6 months prior to enrollment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HR+/HER2- early breast cancer in premenopausal, perimenopausal, and postmenopausal women or men in Saudi Arabia.
Key inclusion criteria (7 listed)
- Signed and dated Patient Informed Consent Form (PICF) obtained.
- The patient is ≥ 18 years-old at the time of PICF signature.
- Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive BC.
- Male or female patients with HER2- BC.
- Patients who are currently receiving ribociclib in combination with adjuvant ET as per approved local label for up to 6 months prior the enrollment date.
Key exclusion criteria (5 listed)
- Ribociclib-based treatment regimen beyond adjuvant therapy for EBC.
- Patients are currently participating in any other clinical trials.
- Patients who previously received any other CDK4/6 inhibitor.
- Patients who refused to sign informed consent.
- According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reason.
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 |
|---|---|---|
| ribociclibThis is an observational study. There is no treatment allocation. The decision to initiate ribociclib will be based solely on clinical judgement. | Drug | Ribocliclib |
Primary outcome
Invasive Breast Cancer-Free Survival (iBCFS)
Time frame: 36 months
iBCFS, defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or invasive contralateral BC. iBCFS will be assessed using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant BC Clinical Trials), as assessed by the investigator, in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB/III EBC.
10 secondary outcomes
Invasive disease free survival (iDFS)
Time frame: Up to 36 months
Distant disease free survival (DDFS)
Time frame: Up to 36 months
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 36 months
Change from baseline in the physical functioning sub-scale score and global health status/QoL scale score as assessed by EORTC QLQ-C30
Time frame: 36 months
Demographics - Age
Time frame: Baseline
Demographics - Gender, race, region
Time frame: Baseline
Clinical characteristics - menopausal status
Time frame: Baseline up to 36 months
Clinical characteristics - anatomical stage
Time frame: Baseline up to 36 months
Clinical characteristics - pre-index chemotherapy and concomitant medication
Time frame: Baseline up to 36 months
Clinical characteristics - medical history
Time frame: Baseline up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HR+/HER2- Early Breast Cancer, run by Novartis Pharmaceuticals at 2 sites in Saudi Arabia.
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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Breast Cancer-Free Survival (iBCFS) (time frame: 36 months). 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 6 Jul 2026.