Real-World Study on CDK4/6 Inhibitors Combined With Endocrine Therapy and Subsequent Treatment in HR+/HER2- MBC.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHunan Cancer Hospital
About this trial
Exploring the Efficacy and Safety of Different Systemic Treatment Regimens after CDK4/6i Progression in the Real World has significant implications. This study is an observational, real-world study. It plans to include over 300 eligible HR+/HER2- metastatic breast cancer patients who are currently receiving or planning to receive endocrine therapy regimens containing CDK4/6 inhibitors. This study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4/6 inhibitors combined with endocrine therapy, based on clinical guideline consensus. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4/6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be chosen by the physician, and the efficacy and safety of subsequent treatment will be evaluated. Additionally, peripheral blood ctDNA testing will be used to assess changes in baseline and progression-related biomarkers, including ESR1, PI3KCA, FGFR1, PTEN, among some patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Prior bilateral oophorectomy or age ≥ 60 years.
Age < 60 with natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without any other pathological or physiological reasons), and estradiol (E2) and follicle-stimulating hormone (FSH) levels consistent with postmenopausal range.
Pre/perimenopausal females may also be eligible but must be willing to receive LHRH agonist during the study.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Disqualifiers
1. Any evidence of severe or uncontrolled systemic illnesses, including uncontrolled hypertension, active bleeding disorders, active infections including hepatitis B, hepatitis C, and human immunodeficiency virus, or severely impaired bone marrow reserve or organ function, including liver and kidney impairment, which, in the investigator's opinion, would greatly alter the risk/benefit balance.
Patient has not yet recovered from any CTCAE grade ≥ 3 toxicity related to prior treatment at the start of CDK4/6 inhibitor therapy.
Known history of allergy to CDK4/6 inhibitors, excipients, or drugs with a similar chemical structure or class as CDK4/6 inhibitors.
Patients deemed unsuitable for enrollment by the investigator.
Trial population
HR+/HER2- metastatic breast cancer patients who are currently receiving or planning to receive endocrine therapy regimens containing CDK4/6 inhibitors.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Different treatment regimens following progression on CDK4/6 inhibitors.
DrugThis study is a single-arm, non-interventional study that evaluates the efficacy and safety of the first-line treatment regimen, which includes CDK4/6 inhibitors combined with endocrine therapy. After disease progression on first-line treatment, the second-line systemic treatment regimen (including but not limited to switching to another CDK4/6 inhibitor combined with endocrine therapy, other types of endocrine therapy, chemotherapy, targeted therapy, etc.) will be evaluated.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: CDK4/6 inhibitors treatment1 intervention
Trial outcomes
Primary outcomes
1
Progression-Free Survival
The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 36 months
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 36 monthsSecondary outcomes
1
Objective Response Rate
It is a statistical measure used in clinical trials to evaluate the effectiveness of a treatment by assessing the proportion of patients who achieve either a partial or complete objective response to the treatment.
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 36 monthsOther outcomes
1
Overall survival
The time from randomization to death from any cause
Time frame
The time from randomization to death from any cause, whichever came first, assessed up to 36 months2
Adverse Events
All adverse events \[including adverse events (AE / SAE) and ADR (adverse drug reactions)\] will be collected when known. The classification of adverse reactions shall refer to CTCAE5.0 in case of adverse events / reactions. In case of serious adverse events, the investigators must immediately take necessary treatment measures to protect the safety of subjects. All adverse events / reactions should be tracked and observed. If the adverse events have not recovered, the investigator shall continue to give necessary treatment, report and record, and deal with special cases according to the management opinions of relevant departments.
Time frame
Primary Outcome Measure: 1.Progression-Free Survival The survival time from the date of randomization to the date of the first documented progression or date of death, whichever came first, assessed up to 60 months [Time Frame: From date of randomizatioSponsors and contacts
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Source ClinicalTrials.gov