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PHASE II STUDY OF LIPOSOME-ENCAPSULATED DOXORUBICIN PLUS PACLITAXEL AND TRASTUZUMAB AS PRIMARY SYSTEMIC THERAPY FOR OPERABLE AND LOCALLY-ADVANCED BREAST CANCER - PACLIDOX 07

PHASE II STUDY OF LIPOSOME-ENCAPSULATED DOXORUBICIN PLUS PACLITAXEL AND TRASTUZUMAB AS PRIMARY SYSTEMIC THERAPY FOR OPERABLE AND LOCALLY-ADVANCED BREAST CANCER - PACLIDOX 07

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001369-27-IT
Enrollment
Unknown
Registered
2009-03-26
Start date
2008-02-12
Completion date
Unknown
Last updated
2014-03-17

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

Conditions

Operable breast cancer patients (T>2 cm, cT2-3, N0-N2, M0) or potentially operable, locally advanced breast cancer patients (T4, N0-2, M0) or inflammatory breast cancer patients (T4d, N0-2, M0), with or without HER2 overexpression or amplification MedDRA version: 9.1 Level: HLT Classification code 10006290 Term: Breast and nipple neoplasms malignant

Interventions

Trade Name: MYOCET Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Doxorubicin Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Sponsors

AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Histologically confirmed breast cancer. - Operable breast cancer patients (T>2 cm, cT2-3, N0-N2, M0) or potentially operable, locally advanced breast cancer patients (T4, N0-2, M0) or inflammatory breast cancer patients (T4d, N0-2, M0), with or without HER2 overexpression or amplificationu` - Hercept-test (DAKO) or FISH performed - Age > 18 and 3 months. 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: - Prior chemotherapy. - History of prior malignancy in the last 10 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ). - Other serious illness or medical condition - Congestive hearth failure or angina pectoris even if it is medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia - Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
Main Objective: - To evaluate the pathological complete response (pCR) rate (A pathological complete response will be defined as disappearance of tumor cells in breast and axillary lymph-nodes by pathological examination);Secondary Objective: - To evaluate the clinical response rate (RR). - To determine the feasibility and systemic tolerability. - To assess the rate of successful breast-conservation surgery;Primary end point(s): - To evaluate the pathological complete response (pCR) rate (A pathological complete response will be defined as disappearance of tumor cells in breast and axillary lymph-nodes by pathological examination)—

Countries

Italy

Outcome results

None listed

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