Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer

Recruiting

• Conditions: Advanced Breast Cancer; ESR1 Gene Mutation
• Interventions: Drug: Endocrine therapy; Drug: Chemotherapy Prednisone

• Registration Number: NCT06548919
• Lead Sponsor: SciClone Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study Start: 2024-08-08
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 450

Inclusion Criteria

• 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.
• 5. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
• 6. have normal organ function (as assessed by the investigator).

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Endocrine therapy	-
Endocrine therapy	Chemotherapy Prednisone	-

Primary Outcome Measures

Name	Time	Method
PFS	18 months	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
DoR	18 months	Duration of response
ORR	6 months	Objective response rate
CBR	6 months	Clinical benefit rate

Trial Locations

Locations (1)

Tianjin Haidafu Internet Hospital; 🇨🇳 Suzhou, Jiangsu, China