Newly diagnosed histologically confirmed high risk HER2-negative breast cancer candidate for neoadjuvant chemotherapy MedDRA version: 14.0 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: EndoTAG-1
Product Code: MDG 09.101
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: paclitaxel
CAS Number: 33069-62-4
Current Sponsor code: MDG 09.100
Concentra
Sponsors
Jules Bordet Institute
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: 1. Metastatic or relapsed disease 2. Major surgery 2) 6. Results of laboratory tests (hematology, chemistry) outside specified limits: • WBC = 3 x 109/L • ANC 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the activity of EndoTAGTM-1 + paclitaxel combination therapy in patients with Her2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of EndoTAGTM-1 + paclitaxel administration vs. baseline. ;Secondary Objective: To evaluate: •Reduction in tumor size as defined by MRI-measured greatest diameter(s) following RECIST criteria at the end of EndoTAGTM-1 + paclitaxel administration •Decrease in MRI-estimated tumor perfusion at the end of EndoTAGTM-1 + paclitaxel administration •Pathological complete response (pCR) •Rate of residual cancer burden at time of surgery •Safety and tolerability of the neoadjuvant regimen •Rate of breast-conserving surgery (BCS) •Rate of clinical complete and partial responses (CR, PR) •Rate of lymph node-negative disease after treatment (node-NEG) To collect frozen tumor biopsies at baseline and surgery for future translational research on DNA and RNA ;Primary end point(s): The percent reduction in MRI-estimated tumor volume at the end of EndoTAGTM-1 + paclitaxel administration vs. baseline.;Timepoint(s) of evaluation of this end point: The end of EndoTAGTM-1 + paclitaxel administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The percent reduction in linear tumour size as measured on MRI by the greatest linear diameter(s) of the tumour following RECIST criteria at the end of EndoTAGTM-1 + paclitaxel administration • The percent reduction in MRI-estimated tumour perfusion at the end of EndoTAGTM-1 + paclitaxel administration • Pathological complete response (pCR) is defined as the absence of any residual invasive cancer in the breast and the absence of any metastatic cells in the regional lymph nodes at the time of surgery (University of Texas MD Anderson Cancer Center trial’s pCR criteria) • Residual cancer burden (RCB) scores are calculated according to the RCB index proposed by Symmans et al (2007) • Rate of breast-conserving surgery (BCS) • Rate of clinical complete and partial responses (CR, PR) • Rate of lymph node-negative disease after treatment (node-NEG) ;Timepoint(s) of evaluation of this end point: The end of EndoTAGTM-1 + paclitaxel administration Surgery | — |
Countries
Belgium
Contacts
Public ContactClinical Trials Information
Jules Bordet Institute
Outcome results
None listed