EUCTR2011-002985-19-BEActive, not recruitingNot Applicable
An open-label phase II trial evaluating the efficacy and safety of neoadjuvant EndoTAGTM-1 in combination with paclitaxel in patients with Her2-negative high risk breast cancer - IJBNeoEndoTAG-1
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Jules Bordet Institute
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1.newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of histological grade > 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy
- •2.Her2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (FISH)
- •3.ECOG performance status 0 or 1
- •4.Gender: female
- •5.Age ? 18 years old
- •6.Negative pregnancy test (females of childbearing potential)
- •7.Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential)
- •8.Signed informed consent
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
Exclusion Criteria
- •1.Metastatic or relapsed disease
- •2.Major surgery < 3 weeks prior to enrollment
- •3.Severe pulmonary obstructive or restrictive disease
- •4.Uncontrolled inflammatory disease (autoimmune or infectious)
- •5.Clinically significant cardiac disease (NYHA stadium > 2)
- •6.Results of laboratory tests (hematology, chemistry) outside specified limits:
- •WBC = 3 x 109/L
- •ANC < 1.5 x 109/L
- •Platelets < 100 x 109/L
- •Hb = 9.0 g/dl (= 5.6 mmol/l)
- •PTT/ INR > 1.5 x ULN
- •AST or ALT > 2.5 x ULN
- •Alkaline Phosphatase > 2 x ULN
- •Total Bilirubin > 1.5 x ULN
- •7.Pregnancy or nursing status
- •8.Known positive HIV testing
- •9.Known hypersensitivity to any component of the EndoTAGTM-1, taxane or FEC formulations
- •10.History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
- •11.History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial
- •12.Concurrent treatment with other experimental products. Participation in another clinical trial with any investigational product within 30 days prior to study entry
Investigators
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