NCT05285332Not yet recruiting
Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapy
Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapywhich Patients Will Benefit From Surgery
Source: ClinicalTrials.gov · Last updated 19 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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）. The investigators 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 362 (estimated)
- First submitted
- 9 Mar 2022
- Start date
- Aug 2022
- Primary completion date
- Dec 2030
- Lead sponsor
- Changhai Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05285332
What you commit to
- Study type: Interventional
- Planned participants: 362
- From Aug 2022 to the primary completion date, Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Accompanied with other primary malignant tumors.
Lab values
- Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).
Other
- More than two visceral organ involvement.
- Patients who can't plan for follow-up effectively and regularly.
Who the study is looking for
- 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.
Criteria the registry did not label
- 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
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Related publications
- Breast surgery for metastatic breast cancer.Cochrane Database Syst Rev · 2025 · PMID 41263247
This page is information, not medical advice. Discuss any trial with your doctor.