Early breast cancer requiring neoadjuvant chimiotherapy MedDRA version: 14.1 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
Trade Name: Adrucil
This treatment is considered as standard of care in the trial
Pharmaceutical Form:
INN or Proposed INN: FLUOROURACIL
CAS Number: 51-21-8
Trade Name: Pharmarubicin
This treatment
Sponsors
Jules Bordet Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female gender 2. Age = 18 years 3. Signed written consent prior to any study specific screening procedures 4. Performance status - Eastern Cooperative Oncology Group (ECOG) 0-1 5. Previously untreated invasive ductal or lobular locally advanced breast cancer or any breast cancer = 2 cm, radiologically measured by breast MRI, with an indication for neoadjuvant chemotherapy; 6. Know receptor status (ER, PgR) HER2 overexpression and Ki67 index defined by local policy. 7. Adequate organ function including: neutrophils = 1.5 x 109 /L platelets = 100 x 109 /L haemoglobin = 10 g/dL bilirubin = 1.25 x upper limit of normal (ULN) Transaminasas: aspartate aminotransferase (AST) = 2.5 x ULN, amino alanine transferase (ALT) = 2.5 x ULN and alkaline phosphate (ALP) = 2.5 x ULN serum creatinine = 1.5 x ULN 8. Baseline left ventricular ejection fraction (LVEF) must be measured within 14 days prior to day 1 of the first anthracyclines cycle and must be = 50% 9. Negative serum pregnancy test, done within 14 days prior to day 1 of the first anthracyclines cycle (for women of childbearing potential) 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Subject received any prior treatment for primary invasive breast cancer 2. Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies); 3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial 4. Contra-indication for MRI examination Claustrophobia Gadolinium hypersensivity Severe renal failure Medical electronic devices carriers 5. Contra-indication for anthracyclines-based chemotherapy 6. Pregnant or lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to evaluate the possible correlation of the early lowering (24-72 hours) of total choline (tCho) contents after the first cycle of neoadjuvant chemotherapy with radiological tumour response assessed with RECIST criteria at the end of anthracycline-based chemotherapy and pathological response at the time of surgery.;Secondary Objective: The secondary objectives are: - To analyse the possible correlation between tCho measurements and clinical response at the end of anthracycline-based chemotherapy and pathological response at the time of surgery with apparent diffusion coefficient (ADC) and vascular permeability parameters Ktrans, Kep, [Gd] measured by other MRI methods in the same examination. - To evaluate serial volumetric measurements of breast tumour on magnetic resonance imaging (MRI) as alternative to longest diameters for response assessment. - To validate A-SCORE genomic signature, which predict resistance to anthracycline and to validate the SET index, a genomic signature created by M.D. Anderson which predict relapse risk in tamoxifen- taxane-anthracycline treated patients. Both signatures evaluate pathological complete response (pCR) as end-point - To correlate baseline genomic signature with choline results as an early marker of response. ;Primary end point(s): Radiological: 1) Complete response (CR) or partial response (PR) according to the RECIST classification system. Pathological: 1) Residual cancer burden (RCB) 2) NSABP pCR definition guidelines ;Timepoint(s) of evaluation of this end point: MRI 1: 1 week within anthracycline start (baseline) MRI 2: 24-72 hours after first cycle of anthracycline MRI 3: Within 1 week prior to starting taxane Additonal MRI for anthracyclines non-responders (24-42 hours after first taxane-based chemotherapy) MRI 4: Within 1 week prior to surgery Tumour and blood samples at baseline (one week before 1st cycle of anthracyclines) and within one week before sur | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Apparent diffusion coefficient (ADC) and vascular permeability parameters (Ktrans, Kep, GD) 2) Volume assessment of breast lesions by MRI 3) Validation of A-SCORE genomic signature ;Timepoint(s) of evaluation of this end point: MRI 1: 1 week within anthracycline start (baseline) MRI 2: 24-72 hours after first cycle of anthracycline MRI 3: Within 1 week prior to starting taxane Additonal MRI for anthracyclines non-responders (24-42 hours after first taxane-based chemotherapy) MRI 4: Within 1 week prior to surgery Tumour and blood samples at baseline (one week before 1st cycle of anthracyclines) and within one week before surgery. | — |
Countries
Belgium
Contacts
Public ContactLemort Marc, MD
Jules Bordet Institute
Outcome results
None listed