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A phase II study of primary chemotherapy with pegylated liposomal doxorubicin (Caelyx), Cisplatin, and Fluorouracil (CCF) followed by metronomic Capecitabine, Cyclophosphamide and Sorafenib (CCS) in early and locally advanced, ?triple negative? breast cancer - ND

A phase II study of primary chemotherapy with pegylated liposomal doxorubicin (Caelyx), Cisplatin, and Fluorouracil (CCF) followed by metronomic Capecitabine, Cyclophosphamide and Sorafenib (CCS) in early and locally advanced, ?triple negative? breast cancer - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-006306-25-IT
Enrollment
Unknown
Registered
2008-07-02
Start date
2008-05-22
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

Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 a-d, N0-3c, M0) or patients with histologically proven local recurrence after breast conserving surgery (rT1-T4, N0-3c, M0, triple negative (absence of ER, PgR and c-erbB2 expression) MedDRA version: 9.1 Level: LLT Classification code 10057654 Term: Breast cancer female

Interventions

Trade Name: CAELYX*INFUS 1FL 2MG/ML 10ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Doxorubicin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concent

Sponsors

ISTITUTO EUROPEO DI ONCOLOGIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria:  Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 a-d, N0-3c, M0) or patients with histologically proven local recurrence after breast conserving surgery (rT1-T4, N0-3c, M0)  Patients with triple negative breast cancer (absence of ER, PgR and c-erbB2 expression on tumor cells defined according to EIO guidelines)  Patients must be suitable for local treatment (surgery) in a multidisciplinary program  Bilateral breast cancers are eligible  Women aged >18 years  Performance status 0-1 (ECOG scale)  Life expectancy of at least 12 wee 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:  Presence of tumor expression of ER and PgR  Presence of tumor HER2/neu overexpression or amplification  Patients with distant metastatic disease  Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are the following:

Design outcomes

Primary

MeasureTime frame
Main Objective: The main objective is to assess the activity in terms of pathological complete remission rate.;Secondary Objective: toxicity, the time to disease progression and the overall survival;Primary end point(s): pathological complete remissions—

Countries

Italy

Outcome results

None listed

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