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

NCT05285332 | Not Yet Recruiting

• 1 other identifier: ChanghaiHTB
• Study Type: interventional
• Target: 362
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Breast Neoplasms; Treatment; Metastatic Breast Cancer; Survival

Keywords

Breast Neoplasms; de-novo metastatic breast cancer; surgical treatment

Outcome Measures

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.

  5 years

Secondary Outcomes (2)

• Distant progression free survival

  5 years

• Locoregional progression free survival

  5 years

Study Arms (4)

1 Primary and metastatic lesions PCR

EXPERIMENTAL

surgery 1 Mastectomy OR Breast conserving surgery

Procedure: surgical treatment 1

2 Primary lesions NPCR and metastatic lesions PCR

EXPERIMENTAL

surgery 1 Mastectomy OR Breast conserving surgery

Procedure: surgical treatment 1

3 Primary lesions PCR and metastatic lesions NPCR

EXPERIMENTAL

surgery 2 Resection of metastasis

Procedure: surgical treatment 2

4 Primary lesions NPCR and metastatic lesions NPCR

EXPERIMENTAL

Systemic therapy Endocrine therapy or chemotherapy or targeted therapy

Drug: Systemic therapy

Interventions

surgical treatment 1 PROCEDURE

Mastectomy OR Breast conserving surgery

Also known as: surgery 1

1 Primary and metastatic lesions PCR; 2 Primary lesions NPCR and metastatic lesions PCR

surgical treatment 2 PROCEDURE

Resection of metastasis

Also known as: surgery 2

3 Primary lesions PCR and metastatic lesions NPCR

Systemic therapy DRUG

Endocrine therapy or chemotherapy or targeted therapy

4 Primary lesions NPCR and metastatic lesions NPCR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Changhai Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• YU YUE, doctor

  Department of thyroid and breast surgery, Changhai Hospital

  STUDY CHAIR

Central Study Contacts

YU YUE, doctor

CONTACT

+86 13564261349; dr-array@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): May 1, 2031
• Last Updated: July 19, 2022

Record last verified: 2022-07