Evaluation of the feasibility of intra-arterial loco-regional chemotherapy in Patients with locally advanced breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002709-23-IT

Enrollment

Registered

2012-10-17

Start date

2012-12-16

Completion date

Unknown

Last updated

2014-06-02

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

Conditions

LOCALLY ADVANCED BREAST CANCER MedDRA version: 14.1 Level: HLT Classification code 10006290 Term: Breast and nipple neoplasms malignant System Organ Class: 100000004864

Interventions

Trade Name: MYOCET*INFUS 2SET 50MG Pharmaceutical Form: Solution for injection INN or Proposed INN: DOXORUBICIN CAS Number: 23214-92-8 Concentration unit: mg/m2 milligram(s)/square meter Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: contraindication to perform a contrast-enhanced MRI or an endovascular procedure. Patients with HER2-positive receptors.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactIstituto di radiologia

Policlinico Gemelli

mromani@rm.unicatt.it0630157091

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026