Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2023-04-30
2025-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Advanced breast cancer patients
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.
Intra-arterial chemoinfusion of breast cancer
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.
Interventions
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Intra-arterial chemoinfusion of breast cancer
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.
Eligibility Criteria
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Inclusion Criteria
* Female had received no prior chemotherapy, radiotherapy, or definitive surgical therapy for breast cancer.
* Patient had adequate organ function.
Exclusion Criteria
* Patient known to have systemic organ failure.
18 Years
FEMALE
No
Sponsors
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Assiut University
OTHER
Responsible Party
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mohamed ahmed abdel wahab
Dr
Principal Investigators
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Mohamed A Abdelwahab, MSc
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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References
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Veronesi U, Boyle P, Goldhirsch A, Orecchia R, Viale G. Breast cancer. Lancet. 2005 May 14-20;365(9472):1727-41. doi: 10.1016/S0140-6736(05)66546-4.
Vinh-Hung V, Verschraegen C, Promish DI, Cserni G, Van de Steene J, Tai P, Vlastos G, Voordeckers M, Storme G, Royce M. Ratios of involved nodes in early breast cancer. Breast Cancer Res. 2004;6(6):R680-8. doi: 10.1186/bcr934. Epub 2004 Oct 6.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.
Other Identifiers
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catheter guided chemo-infusion
Identifier Type: -
Identifier Source: org_study_id