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NCT Number: NCT06548919

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Tianjin Haidafu Internet Hospital

Suzhou, Jiangsu, China

Location status: Recruiting

Location contact

Chunyang Li, Doctor

CONTACT

[email protected]

86-15216717343

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endocrine therapy

Drug

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

Chemotherapy Prednisone

Drug

All chemotherapy treatment regimens approved for advanced breast cancer

Primary outcomes

  1. PFS

    Time frame: 18 months

    Progression-free survival

Secondary outcomes

  1. ORR

    Time frame: 6 months

    Objective response rate

  2. CBR

    Time frame: 6 months

    Clinical benefit rate

  3. DoR

    Time frame: 18 months

    Duration of response

Other outcomes

  1. Adverse event rate

    Time frame: 18 months

    Percentage of occurrences of adverse events

  2. Serious adverse event rate

    Time frame: 18 months

    Percentage of occurrences of serious adverse events

  3. Treatment regimen

    Time frame: 18 months

    Proportion of endocrine therapy, endocrine-targeted combination therapy or chemotherapy

  4. Medication adherence

    Time frame: 18 months

    proportion of days covered

Study contacts

Contact information is provided by the study sponsor or research team.

Chunyang Li

CONTACT

[email protected]

86-15216717343

Sponsors and collaborators

Lead sponsor

SciClone Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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