Breast Cancer
Conditions
Keywords
Breast Cancer, Timing of Radiotherapy, TGF-beta1
Brief summary
The purpose of this study is to compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.
Interventions
DRUGPre-radiotherapy commencement of Arimidex
Arimidex:1mg P.O. daily will be prescribed for 8 weeks in post-mastectomy patients and 9 weeks in BCT patients within the study period. Arimidex starts 3 weeks before adjuvant radiotherapy and throughout the course of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle.
DRUGPost radiotherapy commencement of Arimidex
Arimidex：1mg P.O. daily will be prescribed at 2 weeks after the end of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle.
RADIATIONRadiotherapy
Radiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery
Sponsors
AstraZeneca
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent * Pathological confirmation of breast cancer * ER(+) and/or PR(+). * Post-menopausal woman * Age≤70 years old * Breast conservative surgery with axillary dissection or staging by either sentinel nodes biopsy or axillary sampling * Post-mastectomy patients with T1-T2 and N1-N3, or T3-T4 with any N Negative surgical margins * Karnofsky≥70 * Laboratory criteria: * PLT≥100\*109/L * WBC≥4000/mm3 * HGB≥10g/dl * ALT and AST\<2\*ULN * No presence of metastatic disease * No other malignant tumour
Exclusion criteria
* Presence of metastatic disease. * T1, T2, N0 with mastectomy * Non-infiltrative breast carcinoma underwent mastectomy * Other malignant tumor (concurrent or previous). * Positive surgical margins. * Patients with demonstrated hypersensitivity to Arimidex or any excipient. * Patients with severe renal impairment (creatinine clearance less than 20 ml/min). * Patients with moderate or severe hepatic disease. * Oestrogen-containing therapies should not be co-administered with Arimidex as they would negate its pharmacological action. * Not able or willing to sign informed consent * Autoimmune diseases including scleroderma, systemic lupus erythematosus and so on
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of TGF-β1 | First analysis will occur 1 year after first subject enrolled | To compare TGF-β1 change in concomitant with that in sequential Arimidex in postmenopausal women with breast cancer, as measured by the proportion of patients with an elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other serum inflammatory cytokine | First analysis will occur 1 year after first subject enrolled | Pre-and post-radiotherapy other serum inflammatory cytokine |
| Cosmetic outcomes | First analysis will occur 1 year after first subject enrolled | Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms. |
| Acute skin reaction | First analysis will occur 1 year after first subject enrolled | Acute skin reaction occurrence rate defined by the occurrence of grade II or above acute skin reaction in patients with concurrent or sequential arimidex with radiotherapy. |
| Local-regional recurrence | First analysis will occur 1 year after first subject enrolled | Local-regional recurrence within two arms. |
| Correlation between TGF-β1 Change and Clinical Outcomes | First analysis will occur 1 year after first subject enrolled | The correlation between TGF-β1 change and clinical outcomes will be explored. |
| Lung toxicity | First analysis will occur 1 year after first subject enrolled | Occurrence of grade II or higher radiation-induced lung toxicity. |
Countries
China
Contacts
Primary ContactJiayi Chen, MD
Outcome results
None listed