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-AT

Enrollment

Registered

2005-08-23

Start date

2005-09-27

Completion date

Unknown

Last updated

2013-05-06

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* INN or Proposed INN: paclitaxel CAS Number: 33069-62-4 Concentration unit: mg/g milligram(s)/gram Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 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 measurement) responses according to WHO criteria, - pathologic response as defined by Chevallier (Chevallier et al., 1993), - assessment of biological markers - volumetric assessment.	—

Measure

Time frame

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 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 measurement) responses according to WHO criteria, - pathologic response as defined by Chevallier (Chevallier et al., 1993), - assessment of biological markers - volumetric assessment.

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Countries

Austria, Hungary

Outcome results

None listed

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