Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorSciClone Pharmaceuticals
About this trial
This is a prospective, non-interventional real-world study to observe the efficacy and safety of different treatment regimens in patients with ESR1-mutated HR+/HER2-advanced breast cancer after failure of endocrine therapy.
Epidemiological data, efficacy and safety measures will be collected for each subject. Data on efficacy and safety assessment indicators will be collected every 2-3 months until disease progression, receipt of a new anti-tumour treatment modality, death, loss to follow-up, and arrival at the data collection cut-off date. The cut-off date for data collection is defined as 8 weeks after completion of 6 visits for each subject, or 4 weeks after treatment discontinuation and subject discontinuation/withdrawal. Subjects receiving a different treatment regimen remained subject to assessment of safety indicators 4 weeks after discontinuation of the original treatment regimen.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. must have a histologically or cytologically confirmed diagnosis of breast cancer with evidence of locally advanced disease unsuitable for excision or radical radiotherapy, or evidence of metastatic disease unsuitable for radical treatment.
2. female ≥ 18 years of age
3. female subjects must be postmenopausal (meeting any of the following criteria is sufficient) a) Has undergone oophorectomy. b) Age ≥ 60 years. c) 40 years old < age ≤ 60 years old with 1 year of menopause. d) Age <60 years and receiving ovarian suppression therapy.
4. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
Disqualifiers
1. women who are pregnant or breastfeeding
2. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
3. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator
Trial population
Patients with HR+/HER2-advanced breast cancer with ESR1 mutation after failure of endocrine therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endocrine therapy
DrugAll endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc.
Chemotherapy Prednisone
DrugAll chemotherapy treatment regimens approved for advanced breast cancer
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: Chemotherapy1 intervention
Group B: Endocrine therapy1 intervention
Trial outcomes
Primary outcomes
1
PFS
Progression-free survival
Time frame
18 monthsSecondary outcomes
1
ORR
Objective response rate
Time frame
6 months2
CBR
Clinical benefit rate
Time frame
6 months3
DoR
Duration of response
Time frame
18 monthsOther outcomes
1
Adverse event rate
Percentage of occurrences of adverse events
Time frame
18 months2
Serious adverse event rate
Percentage of occurrences of serious adverse events
Time frame
18 months3
Treatment regimen
Proportion of endocrine therapy, endocrine-targeted combination therapy or chemotherapy
Time frame
18 months4
Medication adherence
proportion of days covered
Time frame
18 monthsSponsors and contacts
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Source ClinicalTrials.gov