Pilot study evaluating the efficacy and safety of preoperative ENDOTAG in combination with Paclitaxel in high risk breast cancer

• Conditions: ewly diagnosed histologically confirmed high risk HER2-negative breast cancer candidate for neoadjuvant chemotherapy; MedDRA version: 14.0Level: LLTClassification code 10006190Term: Breast cancer invasive NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002985-19-BE
• Lead Sponsor: Jules Bordet Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-22
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

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