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

NCT06548919 | Recruiting FDA Drug

• 1 other identifier: ABC-RWS-02
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

ESR1 Gene Mutation; Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-free survival

  18 months

Secondary Outcomes (3)

• ORR

  6 months

• CBR

  6 months

• DoR

  18 months

Other Outcomes (4)

• Adverse event rate

  18 months

• Serious adverse event rate

  18 months

• Treatment regimen

  18 months

Study Arms (2)

Chemotherapy

Drug: Endocrine therapy

Endocrine therapy

Drug: Chemotherapy Prednisone

Interventions

Endocrine therapy DRUG

All endocrine treatment regimens approved for advanced breast cancer, including tamoxifen, aromatase inhibitors, fulvestrant, etc.

Chemotherapy

Chemotherapy Prednisone DRUG

All chemotherapy treatment regimens approved for advanced breast cancer

Endocrine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \. 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.
• \. female ≥ 18 years of age
• \. 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.
• \. ER-positive and HER2-negative status and ESR1-mutation positive must be confirmed.
• \. must have progressed on at least one line of endocrine therapy prior to enrollment, including monotherapy or combination therapy.
• \. have normal organ function (as assessed by the investigator).

You may not qualify if:

• \. women who are pregnant or breastfeeding
• \. known difficulties in tolerating oral medications, or conditions that interfere with the absorption of oral medications or allergies to medications and their excitements
• \. other conditions that make enrollment in the study unsuitable, at the discretion of the investigator

Sponsors & Collaborators

• SciClone Pharmaceuticals: lead

Study Sites (1)

Tianjin Haidafu Internet Hospital

Suzhou, Jiangsu, China

RECRUITING

Central Study Contacts

Chunyang Li

CONTACT

86-15216717343; lichunyang@sciclone.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 12, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)