Phase II, open label, study of primary chemotherapy with Bevacizumab in association with carboplatin, paclitaxel in early and locally advanced triple negative (ER, PgR and HER2 negative) breast cancer - CaPaBe

Phase 1

• Conditions: Patient with early and locally advanced triple negative (ER, PgR and HER2 negative) breast cancer; MedDRA version: 9.1Level: LLTClassification code 10006187

• Registration Number: EUCTR2010-022077-33-IT
• Lead Sponsor: AZIENDA OSPEDALIERA POLICLINICO DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

?Age ?18 years and <75 years
?Pre- or post-menopausal women with histologically proven, previously untreated, primary breast cancer stage II-IIIC
?ER (< 1% by IHC) and PgR (< 1% by IHC) negative
?HER2/neu not overexpressed (Fish negative, or IHC score 0-1+ , or IHC score 2+ AND FISH negative)
?Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ?20 mm with conventional techniques
?Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment
?ECOG performance status < 2 (Karnofsky ?60%)
?Normal organ and marrow function (leukocytes ? 3,000/uL, absolute neutrophil count ?1,500/ul, platelets ?100,000/uL, total bilirubin within normal institutional limits, AST(S-GOT)/ALT(S-GPT) <2.5 x institutional upper limit of normal, creatinine within normal institutional limits or creatinine clearance ?60 mL/min
?Cardiac ejection fraction within normal institutional limits defined as LVEF not below the institutional lower limit of normal by either echocardiogram or MUGA
?Urine dipstick for proteinuria <2+. Patient discovered to have >2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demostrate < 1 g of protein/24hr
?Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of study participation
?Ability to understand and the willingness to sign a written informed consent document.
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

?Presence of distant metastases
?Patients receiving any others investigational agents
?Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study treatment, or minor surgical procedures within 24 hours prior to randomization
?History of allergic reactions attributed to compounds of similar chemical or biologic composition used in the study
?Uncontrolled intercurrent illness including, but not limited, to uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg)ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, symptomatic peripheral neuropathy, or psychiatric illness/social situations that would limit compliance with study requirements
?Serious non-healing wound, peptic ulcer, or bone fracture
?History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of randomization
?Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of agents included in this trial. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified