Evaluation of the feasibility of intra-arterial loco-regional chemotherapy in Patients with locally advanced breast cancer
- Conditions
- OCALLY ADVANCED BREAST CANCERMedDRA version: 14.1Level: HLTClassification code 10006290Term: Breast and nipple neoplasms malignantSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002709-23-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Patients of age, not pregnant, with a clinical, mammographic, ultrasound and/or MRI diagnosis of locally advanced breast cancer (stage III A-B, according to the seventh edition of the TNM staging of the American Joint Committee on Cancer,
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
contraindication to perform a contrast-enhanced MRI or an endovascular procedure. Patients with HER2-positive receptors.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • To evaluate the feasibility and safety of intra-arterial loco-regional chemoinfusion of adriamycin and docetaxel administrated selectively in the internal mammary artery, in the lateral thoracic artery and/or in the thoraco acromial artery, associated with systemic neoadjuvant chemotherapy in Patients with locally advanced breast cancer.;Secondary Objective: • To evaluate volume reduction of breast cancer with MRI, comparing the two different neoadjuvant approaches, and to assess if there is a statistically significant difference between them in obtaining complete responses.;Primary end point(s): • To evaluate the incidence of adverse events.;Timepoint(s) of evaluation of this end point: 3 WEEKS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • To evaluate volume reduction of breast cancer with MRI, comparing the two different neoadjuvant approaches, and to assess if there is a statistically significant difference between them in obtaining complete responses.;Timepoint(s) of evaluation of this end point: 3 WEEKS