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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorChanghai Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • surgical treatment 1

    Procedure/Surgery

    Mastectomy OR Breast conserving surgery

  • surgical treatment 2

    Procedure/Surgery

    Resection of metastasis

  • Systemic therapy

    Drug

    Endocrine therapy or chemotherapy or targeted therapy

Treatment groups

362 Participants
are divided into 4 treatment groups
Group A: 1 Primary and metastatic lesions PCRExperimental treatment 1 intervention
Group B: 2 Primary lesions NPCR and metastatic lesions PCRExperimental treatment 1 intervention
Group C: 3 Primary lesions PCR and metastatic lesions NPCRExperimental treatment 1 intervention
Group D: 4 Primary lesions NPCR and metastatic lesions NPCRExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes.

Time frame
5 years

Secondary outcomes

1

Distant progression free survival

Distant disease free survival (D-DFS), which defined as the time from the diagnosis of de novo stage IV breast cancer to the confirmed time of distant progression, or death due to any other cause.

Time frame
5 years
2

Locoregional progression free survival

Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.

Time frame
5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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