Status:
NOT_YET_RECRUITING
Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapy
Lead Sponsor:
Changhai Hospital
Conditions:
Breast Neoplasms
Treatment
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
For patients with de novo stage IV breast cancer, the current debate is whether local surgery can improve the survival of patients. There is no clinical study on the classification after systemic trea...
Detailed Description
This study analysed and summarized the outcomes of the primary and metastatic lesions after first-line systemic therapy in patients with newly diagnosed breast cancer and then inferred the timing of s...
Eligibility Criteria
Inclusion
- Study Population Operable stage IV breast cancer patients, whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imaginology examination
- Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.
- ECOG-PS 0-2.
- Bone marrow, liver and kidney should be fully functional.
- Patients didn't received the locoregional surgery of the primary tumor in de novo.
- For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.
Exclusion
- Accompanied with other primary malignant tumors.
- More than two visceral organ involvement.
- Patients who can't plan for follow-up effectively and regularly.
- Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2031
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT05285332
Start Date
August 1 2022
End Date
May 1 2031
Last Update
July 19 2022
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