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

Breast Neoplasms Clinical Trial

— CS  

Official title:

Classified Treatment Strategy for De-novo Metastatic Breast Cancer After Systemic Adjuvant Therapywhich Patients Will Benefit From Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05285332
• Other study ID #: ChanghaiHTB
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: May 1, 2031

Study information

• Verified date: July 2022
• Source: Changhai Hospital
• Contact: YU YUE, doctor
• Phone: +86 13564261349
• Email: dr-array[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study analysed and summarized the outcomes of the primary and metastatic lesions after first-line systemic therapy in patients with newly diagnosed breast cancer and then inferred the timing of surgical treatment. According to the tumour heterogeneity characteristics between the primary and metastatic tumours, the investigators investigated the following A, B and C scenarios. After systemic therapy in patients with de novo metastatic breast cancer, the outcomes of primary and metastatic lesions were mainly divided into four categories (Fig. 1a, b, c, d). It is worth noting that after treatment, the four conditions of a, b, c, and d may alternate with the progression of the tumour or modification of the treatment plan. Therefore, only a proactive evaluation and timely treatment can identify the time window for tumour treatment. The time window for surgical treatment is important because, once missed, the tumour may progress with new metastatic lesions. Figure 1-a: Imaging study indicates complete remission of primary and metastatic tumours. Diagnostic surgical treatment can be performed to determine whether a pathologic complete response (PCR) is achieved and to develop a subsequent treatment plan. Figure 1-b: Imaging study indicates complete remission of the metastatic tumour with residual primary tumour. The state of the patient in this scenario could be equivalent to that of patients with early resectable breast cancer. Surgical treatment of the primary tumour should be promptly performed. Figure 1-c: Complete remission of the primary and residual metastatic tumour. Surgical treatment can be selected for isolated and resectable metastatic tumour. Figure 1-d: No remission or even progression of the primary and metastatic tumours. The systemic treatment plan should be replaced, and the surgical treatment should not be considered.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 362
• Est. completion date: May 1, 2031
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Survival
• Treatment

Intervention

Procedure:
• surgical treatment 1
Mastectomy OR Breast conserving surgery
• surgical treatment 2
Resection of metastasis

Drug:
• Systemic therapy
Endocrine therapy or chemotherapy or targeted therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	5 years
Secondary	Locoregional progression free survival	Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.	5 years