Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapy

• Status: Not yet recruiting
• Trial end date: 2031-05-01
• Target enrollment: 0
• Participant gender: Female

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 treatment of de novo stage IV breast cancer patients. In fact, the clinical stage of tumor can change with the change of treatment. For example, the stage Ⅲ of locally advanced breast cancer can down-staging to the stage Ⅱ after systemic treatment. Similarly, patients with stage Ⅳ can down-staging to stage Ⅱ or stage Ⅲ after systemic treatment. At this time, the patient can receive surgical treatment. Therefore, this study is to first treat de novo stage IV breast cancer patients with systemic treatment, according to the response after systemic treatment to give different treatment measures（surgery or continued systemic treatment）. We hope that this study will provide new ideas for the treatment of de novo stage IV breast cancer and other de novo stage IV cancers.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital

Criteria

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

Inclusion Criteria:

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 Criteria:

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).