Breast CancerNCT05795335
CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer
An observational study of Breast Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CDK4/6 inhibitor
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2023to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hormone receptor-positive breast cancer patients who have received or plan to receive CDK4/6 inhibitors for advanced disease.
Who may be able to join
- Aged ≥18 and older
- Confirmed diagnosis of hormone receptor-positive breast cancer.
- Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
- Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
- ECOG 0-2
- Adequate organ function
Who cannot join
- Subjects disable to swallow pills.
- History of immunodeficiency disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
jinsong Lu, MD, lujingsong@renji.com
About this study
Official title: Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study
This is an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.
- Conditions
- Breast Cancer
- Being tested
- CDK4/6 inhibitor
- Keywords
- Locoregionally Recurrent, Metastatic, CDK4/6 Inhibitors
- 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.
CDK4/6 inhibitorDrug
CDK4/6 inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Patients have received or plan to receive CDK4/6 inhibitors for advanced disease. | Not described Receives: Drug: CDK4/6 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first.
Measured: From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)
Secondary outcomes (2)
Overall survival
Overall survival is defined as the time from starting CDK4/6 inhibitor to death from any cause.
Measured: From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years
Adverse events
Adverse events during CDK4/6 regimen will be assessed according to the NCI CTCAE v5.0.
Measured: From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start30 Apr 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
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 RenJi HospitalThe 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
- Other
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsong Lu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795335
- Sponsor's protocol ID
- KY2022-097-B
- Status last verified
- May 2023
- First submitted
- 21 Mar 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Outcomes, Adverse Events and Predictive Biomarkers for CDK4/6 Inhibitors in Patients With Hormone Receptor-positive Advanced Breast Cancer, an Ambispective Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT05795335
- Acronym / sponsor ID
- KY2022-097-B
- Conditions
- Breast Cancer
- Keywords
- Locoregionally Recurrent, Metastatic, CDK4/6 Inhibitors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 3 Apr 2023 (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 an ambispective, single-center study to evaluate the survival outcomes, adverse events and predictive biomarkers for CDK4/6 inhibitors in patients with hormone receptor-positive advanced breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients have received or plan to receive CDK4/6 inhibitors for advanced disease. | – | Drug: CDK4/6 inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hormone receptor-positive breast cancer patients who have received or plan to receive CDK4/6 inhibitors for advanced disease.
Key inclusion criteria (6 listed)
- Aged ≥18 and older
- Confirmed diagnosis of hormone receptor-positive breast cancer.
- Subjects with locoregionally recurrent or metastatic disease not amenable to curative therapy.
- Subjects have received or plan to receive CDK4/6 inhibitors for advanced disease.
- ECOG 0-2
Key exclusion criteria (2 listed)
- Subjects disable to swallow pills.
- History of immunodeficiency disease
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 |
|---|---|---|
| CDK4/6 inhibitorCDK4/6 inhibitors | Drug | Patients have received or plan to receive CDK4/6 inhibitors for advanced disease. |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)
PFS is defined as the time from the date of starting CDK4/6 inhibitor to the date of objective tumor progression as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) or death from any cause in the absence of documented PD, whichever occurs first.
2 secondary outcomes
Overall survival
Time frame: From the date of starting CDK4/6 inhibitor until death from any cause up to 3 years
Adverse events
Time frame: From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 2.5 years)
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 16 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 RenJi Hospital 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 6 inclusion and 2 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 16 May 2023. 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?
Contact Ziping Wu, MD (86(21)68385569, wuziping@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From the date of starting CDK4/6 inhibitor to the date of first documentation of progression or death (up to approximately 2.5 years)). 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 16 May 2023.