A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer
18 Years
70 Years
Female
Breast Cancer
Trial Information
A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Level of TGF-β1
Outcome Description:
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.
Outcome Time Frame:
First analysis will occur 1 year after first subject enrolled
Safety Issue:
No
Principal Investigator
Jiayi Chen, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Department of Radiation Oncology, Fudan University Cancer Hospital
Authority:
China: Ethics Committee
Study ID:
BR-RT-002
NCT ID:
NCT01402193
Start Date:
July 2011
Completion Date:
December 2013
Related Keywords:
- Breast Cancer
- Breast Cancer
- Timing of Radiotherapy
- TGF-beta1
- Breast Neoplasms
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