Catheter Guided Chemo-infusion in Breast Cancer

Study Overview
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Brief Summary
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In the present prospective study, we will analyze the outcome of image-guided delivery of intra-arterially infused chemotherapeutic drugs for patients with breast cancer in III, IV stages.

Detailed Description
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Breast cancer is one of the most common malignancies affecting women worldwide, and its incidence has seen a steady increase over the years with the involvement of women at a much younger age, which poses a serious health threat to women and has a staggering global impact. Lymph node and hematogenous metastasis occurs at the early stage of breast cancer and is the principal cause of mortality of breast cancer patients. Surgical resection is the most effective method for the treatment of breast cancer, and neoadjuvant chemotherapy reduces the risk of disease recurrence and death in women who have operable breast cancer. For patients with inoperable breast cancer, neoadjuvant chemotherapy reduces tumor bulk and tumor stage, thereby increasing the chance of surgical resection and reducing postoperative tumor recurrence and metastasis. Local or regional chemotherapy is an alternative for reducing metastatic lesions and increasing patient survival .Intra-arterial infusion chemotherapy (chemoinfusion), a form of regional chemotherapy, has been used in the treatment of gastrointestinal tumors, liver cancer, and pancreatic cancer. In the present prospective study, we will analyze the outcome of image-guided delivery of intra-arterially infused chemotherapeutic drugs for patients with breast cancer in III, IV stages.

Official Title
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Role of Catheter Guided Intra-arterial Chemo-infusion in Breast Cancer.

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Intra-arterial chemoinfusion of breast cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female had stage III,IV breast cancer. Female had received no prior chemotherapy, radiotherapy, or definitive surgical therapy for breast cancer. Patient had adequate organ function. Exclusion Criteria: Patients known to have absolute contraindications for contrast. Patient known to have systemic organ failure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Adult female had stage III,IV breast cancer with no prior chemotherapy, radiotherapy, or definitive surgical therapy for breast cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Advanced breast cancer patients<br>Tumors are staged according to the criteria of the Union for International Cancer Control (UICC). Tumor volume was determined by mammography or magnetic resonance imaging (MRI). Patients will be cannulated via the femoral artery. Then, a 4F fixed-curve catheter (Cobra catheter, Cook Corporation, Bloomington) was advanced to the ipsilateral subclavian artery. Digital subtraction angiography (DSA) was performed to determine tumor arterial blood supply. Super selection of the internal mammary artery done by micro-catheter. Chemo-infusion was decided by the major feeding artery. The intra-arterial chemoinfusion regimen consisted of docetaxel 75 mg/m2 and epirubicin 50 mg/m2 in 200 mL of normal saline and 5% glucose; the drugs were slowly infused via the catheter over at least 15 minutes. Intraarterial infusion was performed once every 3 weeks on average. | Procedure: Intra-arterial chemoinfusion of breast cancer<br>* Patients will be cannulated via the femoral artery. Then, a 4F fixed-curve catheter (Cobra catheter, Cook Corporation, Bloomington) was advanced to the ipsilateral subclavian artery. Digital subtraction angiography (DSA) was performed to determine tumor arterial blood supply. Super selection of the internal mammary artery done by micro-catheter. Chemo-infusion was decided by the major feeding artery. The intra-arterial chemoinfusion regimen consisted of docetaxel 75 mg/m2 and epirubicin 50 mg/m2 in 200 mL of normal saline and 5% glucose; the drugs were slowly infused via the catheter over at least 15 minutes. Intraarterial infusion was performed once every 3 weeks on average.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion size after chemotherapy | Patient will be evaluated 3 weeks after the second intra-arterial chemo infusion. If the primary lesion and the involved lymph nodes shrunken markedly in volume and skin and muscle involvement improved noticeably, patients were assigned to undergo surgical resection | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, chemotherapy