Clinical trial NCT05661656: Catheter Guided Chemo-infusion in Breast Cancer
Official title: Role of Catheter Guided Intra-arterial Chemo-infusion in Breast Cancer.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
chemotherapy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Adult female had stage III,IV breast cancer with no prior chemotherapy, radiotherapy, or definitive surgical therapy for breast cancer.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lesion size after chemotherapy
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed A Abdelwahab, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.