An interventional study of surgical treatment 1 and surgical treatment 2 in Breast Neoplasms, Treatment and Metastatic Breast Cancer, sponsored by Changhai Hospital. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
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.
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 362 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Changhai Hospital is the lead sponsor of 354 studies on the registry; 136 are open to participants now.
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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:
Exclusion Criteria:
surgery 1 Mastectomy OR Breast conserving surgery
Procedure: surgical treatment 1
surgery 1 Mastectomy OR Breast conserving surgery
Procedure: surgical treatment 1
surgery 2 Resection of metastasis
Procedure: surgical treatment 2
Systemic therapy Endocrine therapy or chemotherapy or targeted therapy
Drug: Systemic therapy
Mastectomy OR Breast conserving surgery
Also known as: surgery 1
Resection of metastasis
Also known as: surgery 2
Endocrine therapy or chemotherapy or targeted therapy
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
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
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
No study locations are listed for this record.
Start is estimated for Aug 2022; primary completion for Dec 2030, 100 months later.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's planned 100 months is above that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
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This study is not yet recruiting, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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