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-HU
- Lead Sponsor
- DIATOS S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 10
Histologically confirmed invasive primary breast cancer from core needle biopsy
Post-menopausal patients with hormone receptor positive tumor meaning estrogen and/or progesterone receptor 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
Distant metastases
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
- Secondary Outcome Measures
Name Time Method