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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001417-18-HU

Enrollment

Registered

2006-03-31

Start date

2006-06-20

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Invasive primary breast cancer

Interventions

Product Name: DTS-301 Product Code: DTS-301 Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess the tumor response in patients with primary breast cancer further a single intratumoral injection of DTS-301 prior surgery;Secondary Objective: Assess the safety of intratumoral injection of DTS-301 as neoadjuvant therapy in breast cancer Determine plasma pharmacokinetics of paclitaxel after intratumoral injection of DTS-301;Primary end point(s): tumor response including - clinical (caliper measurement) and radiological (MRI and ultrasound measurements) responses according to WHO criteria - pathologic response as defined by Chevallier (Chevallier et al., 1993) - assessment of biological markers - volumetric assessment of tumors	—

Measure

Time frame

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

—

Countries

Hungary

Outcome results

None listed

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