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

Effectiveness and Safety of Different Treatment Regimens in Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer After Failure of Prior Endocrine Therapy: a Prospective, Non-interventional, Real-world Study

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Breast Cancer; ESR1 Gene Mutation
• Intervention / Treatment: Drug: Endocrine therapy; Drug: Chemotherapy Prednisone

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Chunyang Li; Phone Number: 86-15216717343; Email: lichunyang@sciclone.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • Tianjin Haidafu Internet Hospital
      • Contact: Chunyang Li, Doctor; Phone Number: 86-15216717343; Email: lichunyang@sciclone.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with HR+/HER2-advanced breast cancer with ESR1 mutation after failure of endocrine therapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chemotherapy	Drug: Endocrine therapy; All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc.
Endocrine therapy	Drug: Chemotherapy Prednisone; All chemotherapy treatment regimens approved for advanced breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-free survival	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective response rate	6 months
CBR	Clinical benefit rate	6 months
DoR	Duration of response	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate	Percentage of occurrences of adverse events	18 months
Serious adverse event rate	Percentage of occurrences of serious adverse events	18 months
Treatment regimen	Proportion of endocrine therapy, endocrine-targeted combination therapy or chemotherapy	18 months
Medication adherence	proportion of days covered	18 months

Collaborators and Investigators

• Sponsor: SciClone Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 7, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 12, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: ABC-RWS-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No