Advanced Breast CancerCAMELIANCT06926088
Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer
An observational study of Advanced Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Exploring the Impact of body mass index on the efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy in advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Mar 2026
- 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: Patients aged ≥18 years with advanced HR-positive breast cancer who received CDK4/6 inhibitors at six hospitals in China were included in this study.
Who may be able to join
- 18 years of age and above;
- Women of any menstrual status;
- Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable;
- Patients with histological pathology that is clearly HR-positive/HER2-negative breast cancer, or if there is metastatic pathology, the histological pathology of the metastatic foci shall prevail. (Those with ER intensity >1% cellular nuclear staining)
- Patients have at least 3 more fully documented medical records at the enrolled centre, including at least 1 inpatient record.
Who cannot join
- CDK4/6 inhibitors as neoadjuvant or adjuvant therapy;
- Significantly missing diagnostic and treatment data from patients' medical records;
- Participation in other clinical trials before and during the data collection period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer: a Multi-center, Real-world Study
Exploring the Impact of body mass index on the efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy in advanced breast cancer.
Read the detailed description
Body mass index (BMI) is strongly associated with the development and progression of breast cancer. Despite the widespread use of cyclin-dependent kinase (CDK) 4/6 inhibitors combined with endocrine therapy (ET) in hormone receptor (HR)-positive advanced breast cancer, the effect of BMI on therapeutic outcomes remains poorly understood. Here, we present real-world evidence to substantiate the association between BMI and CDK4/6 inhibitors efficacy and safety.
- Conditions
- Advanced Breast Cancer
- Being tested
- Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety
- Keywords
- BMI, CDK4/6 Inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of BMI on CDK4/6 Inhibitors Efficacy and SafetyDrug
Patients aged ≥18 years with advanced HR-positive breast cancer who received CDK4/6 inhibitors at six hospitals in China were included in this study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | BMI < 25.0 kg/m² Receives: Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety | |
| Group 2 | BMI ≥ 25.0 kg/m² Receives: Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (3)
Overall Survival (OS)
It is defined as the time from the start of treatment to death for any reason.
Measured: It is defined as the time from the start of treatment to death for any reason, whichever came first, assessed up to 100 months
Objective Response Rate (ORR)
The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set
Measured: From date of observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The Number of Participants Who Experienced Adverse Events
Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).
Measured: From date of observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study startDec 2016
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926088
- Sponsor's protocol ID
- CAMELIA
- Acronym
- CAMELIA
- Status last verified
- Apr 2025
- First submitted
- 30 Mar 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of BMI on CDK4/6 Inhibitors Efficacy and Safety in Advanced Breast Cancer: a Multi-center, Real-world Study
- ClinicalTrials.gov ID
- NCT06926088
- Acronym / sponsor ID
- CAMELIA / CAMELIA
- Conditions
- Advanced Breast Cancer
- Keywords
- BMI, CDK4/6 Inhibitors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Apr 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.
Exploring the Impact of body mass index on the efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy in advanced breast cancer.
Detailed description
Body mass index (BMI) is strongly associated with the development and progression of breast cancer. Despite the widespread use of cyclin-dependent kinase (CDK) 4/6 inhibitors combined with endocrine therapy (ET) in hormone receptor (HR)-positive advanced breast cancer, the effect of BMI on therapeutic outcomes remains poorly understood. Here, we present real-world evidence to substantiate the association between BMI and CDK4/6 inhibitors efficacy and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and SafetyBMI < 25.0 kg/m² |
| Group 2 | – | Drug: Impact of BMI on CDK4/6 Inhibitors Efficacy and SafetyBMI ≥ 25.0 kg/m² |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years with advanced HR-positive breast cancer who received CDK4/6 inhibitors at six hospitals in China were included in this study.
Key inclusion criteria (5 listed)
- 18 years of age and above;
- Women of any menstrual status;
- Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable;
- Patients with histological pathology that is clearly HR-positive/HER2-negative breast cancer, or if there is metastatic pathology, the histological pathology of the metastatic foci shall prevail. (Those with ER intensity >1% cellular nuclear staining)
- Patients have at least 3 more fully documented medical records at the enrolled centre, including at least 1 inpatient record.
Key exclusion criteria (3 listed)
- CDK4/6 inhibitors as neoadjuvant or adjuvant therapy;
- Significantly missing diagnostic and treatment data from patients' medical records;
- Participation in other clinical trials before and during the data collection period.
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 |
|---|---|---|
| Impact of BMI on CDK4/6 Inhibitors Efficacy and SafetyPatients aged ≥18 years with advanced HR-positive breast cancer who received CDK4/6 inhibitors at six hospitals in China were included in this study. | Drug | Group 1, Group 2 |
Primary outcome
Progression Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
3 secondary outcomes
Overall Survival (OS)
Time frame: It is defined as the time from the start of treatment to death for any reason, whichever came first, assessed up to 100 months
Objective Response Rate (ORR)
Time frame: From date of observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The Number of Participants Who Experienced Adverse Events
Time frame: From date of observation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 13 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Advanced Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2025. 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 China. 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?
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?
Progression Free Survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 13 Apr 2025.