A Phase II Clinical Trial to Evaluate Intratumoral Injection of a Depot Formulation of Paclitaxel (DTS-301) as Neoadjuvant Therapy of Patients with Breast Cancer

• Conditions: Invasive primary breast cancer

• Registration Number: EUCTR2005-001417-18-AT
• Lead Sponsor: DIATOS S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-23
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

Female patients = 18 years of age
Histologically confirmed invasive primary breast cancer from core needle biopsy
Post-menopausal patients with hormone receptor positive tumor meaning estrogen and/or progesterone recptor positive (cut-off: 10% stained cells)
Single palpable tumor of 1.5 to 4 cm in diameter
Adequate hematological, renal and hepatic functions
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Distant metastasis
Multicentric and bilateral breast cancer
Inflammatory breast disease
Previous radiotherapy, surgery, hormonal therapy for breast cancer
Previous chemotherapy for malignant disease within the past 3 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the tumor response in post-menopausal patients with hormone receptor-positive primary breast cancer after a single intratumoral injection of DTS-301 prior to surgery;Secondary Objective: Assess the safety of intralesional injection of DTS-301 as neoadjuvant therapy in breast cancer<br>Determine plasma pharmacokinetics of paclitaxel after intratumoral injection of DTS-301;Primary end point(s): Tumor response including <br>- clinical (caliper measurement) and radiological (MRI and ultrasound measurement) responses according to WHO criteria, <br>- pathologic response as defined by Chevallier (Chevallier et al., 1993), <br>- assessment of biological markers <br>- volumetric assessment.