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Catheter Guided Chemo-infusion in Breast Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05661656
Enrollment
50
Registered
2022-12-22
Start date
2023-04-30
Completion date
2025-05-31
Last updated
2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, chemotherapy

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.

Interventions

PROCEDUREIntra-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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Adult female had stage III,IV breast cancer with no prior chemotherapy, radiotherapy, or definitive surgical therapy for breast cancer.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Lesion size after chemotherapy3 weeksPatient 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

Contacts

Primary ContactMohamed A Abdelwahab, MSc
ma7225864@gmail.com01016307405
Backup ContactSamy Abd Al Aziz, MD
samy5abdelaziz@yahoo.com01006788053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026