Large (>/=3 cm) or locally advanced breast cancers MedDRA version: 14.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Xeloda
Pharmaceutical Form: Coated tablet
Other descriptive name: Xeloda
Concentration unit: gm/m2 gram(s)/square meter
Concentration type: range
Concentration number: 168-252
Trade Name:
Sponsors
United Lincolnshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women with histologically confirmed carcinoma of the breast, with measurable or evaluable large (= 3cm) or locally advanced (T3, T4, TxN2) disease 2. Women who are over 18 and under 75 years and able to sign the informed consent 3. Ability to comply with study and follow-up procedures 4. Adequate left ventricular function at study entry, defined as LVEF = 50% by echocardiography (ECHO) 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. WHO performance status 2, 3 and 4 2. Prior chemotherapy or radiotherapy unless for basal cell carcinoma 3. Unstable angina and/or evidence of significant cardiac dysfunction 4. Patients who have diabetes requiring insulin 5. Pregnancy or lactation 6. Inadequate organ function, as evidenced by any of the following laboratory values: Absolute neutrophil count 1.5 mg/dL; Alkaline phosphatase, AST, and/or ALT > 2x upper limit of normal; Serum creatinine > 2.0 mg/dL; PTT and/or either INR or PT > 1.5x upper limit of normal (except for subjects receiving anti-coagulation therapy); Urine protein/creatinine ratio > 1.0 at screening 7. Inability to complete Quality of Life questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether capecitabine, when combined with docetaxel and following adriamycin and cyclophosphamide, can significantly enhance the complete pathological response rate (> 30%) in the primary breast cancers and tumour draining axillary lymph nodes of women with large or locally advanced breast cancers (LLABCs). ;Secondary Objective: 2.2.1 To document the quality of life (QoL) and related morbidity with these novel drug combinations, including the use of G-CSF in a primary prophylactic setting. 2.2.2 To define, accurately and reliably, the predictive value of response to chemotherapy of specific proteins/genes, previously identified and characterised in an in vitro study. 2.2.3 To evaluate the host defences in women with breast cancer undergoing chemotherapy, and establishing the contribution of these defences to the beneficial effects documented. 2.2.4 To assess the effectiveness of magnetic resonance mammography scans as predictors of early clinical response to neoadjuvant chemotherapy. ;Primary end point(s): To improve the complete pathological response rate of the breast cancer and tumour draining axillary lymph nodes to a novel combination of drugs in the neoadjuvant setting.;Timepoint(s) of evaluation of this end point: Following completion of trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To document the quality of life (QoL) and related morbidity with these novel drug combinations, including the use of G-CSF in a primary prophylactic setting. To define, accurately and reliably, the predictive value of response to chemotherapy of specific proteins/genes, previously identified and characterised in an in vitro study. To evaluate the host defences in women with breast cancer undergoing chemotherapy, and establishing the contribution of these defences to the beneficial effects documented. To assess the effectiveness of magnetic resonance mammography scans as predictors of early clinical response to neoadjuvant chemotherapy. ;Timepoint(s) of evaluation of this end point: To document the quality of life (QoL) and related morbidity with these novel drug combinations, including the use of G-CSF in a primary prophylactic setting: following completion of trial To define, accurately and reliably, the predictive value of response to chemotherapy of specific proteins/genes, previously identified and characterised in an in vitro study: 18 months - 24 months after completion of trial. To evaluate the host defences in women with breast cancer undergoing chemotherapy, and establishing the contribution of these defences to the beneficial effects documented: following completion of trial. To assess the effectiveness of magnetic resonance mammography scans as predictors of early clinical response to neoadjuvant chemotherapy: following completion of trial. | — |
Countries
United Kingdom
Contacts
Public ContactResearch & Development Department
United Lincolnshire Hospitals NHS Trust
Outcome results
None listed