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Search / Trial NCT05285332

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

Launched by CHANGHAI HOSPITAL · Mar 16, 2022

Trial Information

Current as of September 07, 2025

Not yet recruiting

Keywords

Breast Neoplasms De Novo Metastatic Breast Cancer Surgical Treatment

ClinConnect Summary

This clinical trial is investigating whether surgery can help improve survival for women with a specific type of breast cancer called de novo stage IV breast cancer, which means the cancer has spread to other parts of the body at the time of diagnosis. The study will first treat these patients with medication (called systemic treatment) to see how well their cancer responds. Depending on their response to this treatment, patients may then receive surgery or continue with more medication. The goal is to learn more about how to best treat this type of cancer and possibly improve outcomes for patients.

To be eligible for this trial, participants must be women diagnosed with stage IV breast cancer that can be operated on, and the cancer must be confirmed through medical tests. They should be in good overall health, with certain organs functioning well, and should not have had prior surgery for their breast cancer. Additionally, they should not have other serious health issues that could complicate their treatment. Participants can expect close monitoring throughout the trial and to receive treatment based on how their cancer responds to the initial medication. This study is not yet recruiting patients, but it aims to provide valuable insights into the treatment of advanced breast cancer.

Gender

FEMALE

Eligibility 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).

About Changhai Hospital

Changhai Hospital is a leading medical institution dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to excellence, the hospital integrates cutting-edge medical technologies and a multidisciplinary approach to patient care. Changhai Hospital actively collaborates with research organizations and healthcare professionals to conduct rigorous clinical trials aimed at developing new treatments and improving patient outcomes. By prioritizing patient safety and ethical standards, the hospital plays a pivotal role in contributing to the advancement of medical knowledge and the enhancement of therapeutic options.

Locations

Patients applied

0 patients applied

Trial Officials

YU YUE, doctor

Study Chair

Department of thyroid and breast surgery, Changhai Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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