Inflammatory breast cancer MedDRA version: 9.1 Level: PT Classification code 10021980
Conditions
Interventions
Trade Name: ENDOXAN BAXTER*50CPR RIV 50MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Cyclophosphamide
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration nu
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically proven inflammatory primary breast cancer cT4d, or rT4d, N0-3c, any ER e PgR, HER2 positive or negative Women aged 1870 years ER, PgR and c-erbB-2 expression defined according to Pathology Division IEO No evidence of distant metastatic disease No previous preoperative treatment for breast cancer PS=0-2 (ECOG) LVEF ≥ 55% with Echocardiography or MUGA Scan Negative pregnancy test 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: Non inflammatory breast cancer Patients with metastatic disease Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy, on the rate of pathological complete remission (pCR), of the combination of weekly carboplatin and paclitaxel in combination with bevacizumab, oral cyclophosphamide plus trastuzumab in patients with HER2 positive tumors and endocrine therapy in endocrine responsive tumors in patients with primary inflammatory breast cancer (IBC) or recurrent IBC candidate to locoregional definitive treatment.;Secondary Objective: To assess the safety and the tolerability of the combination;Primary end point(s): The rate of pCR (pathological complete remission) defined as the complete disappearance of invasive tumor both in the breast and in the axilla; the objective response rate according to the RECIST criteria when applicable and clinically evaluable skin criteria including erythema, edema, peau dorange; | — |
Countries
Italy
Outcome results
None listed