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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasms; Metastatic Breast Cancer; Treatment; Survival
• Intervention / Treatment: Procedure: surgical treatment 1; Procedure: surgical treatment 2; Drug: Systemic therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 362
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YU YUE, doctor; Phone Number: +86 13564261349; Email: dr-array@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 Primary and metastatic lesions PCR; surgery 1 Mastectomy OR Breast conserving surgery	Procedure: surgical treatment 1; Mastectomy OR Breast conserving surgery; Other Names: surgery 1
Experimental: 2 Primary lesions NPCR and metastatic lesions PCR; surgery 1 Mastectomy OR Breast conserving surgery	Procedure: surgical treatment 1; Mastectomy OR Breast conserving surgery; Other Names: surgery 1
Experimental: 3 Primary lesions PCR and metastatic lesions NPCR; surgery 2 Resection of metastasis	Procedure: surgical treatment 2; Resection of metastasis; Other Names: surgery 2
Experimental: 4 Primary lesions NPCR and metastatic lesions NPCR; Systemic therapy Endocrine therapy or chemotherapy or targeted therapy	Drug: Systemic therapy; Endocrine therapy or chemotherapy or targeted therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional progression free survival	Defined as time between the time of diagnosis and the time of locoregional recurrence, or death occurred.	5 years
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

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Study Chair: YU YUE, doctor, Department of thyroid and breast surgery, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): May 1, 2031

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 17, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Breast Neoplasms; surgical treatment; de-novo metastatic breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ChanghaiHTB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No