Status:
UNKNOWN
Study of Arimidex and Radiotherapy Sequencing
Lead Sponsor:
Fudan University
Collaborating Sponsors:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 elev...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2015
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01402193
Start Date
July 1 2011
End Date
July 1 2015
Last Update
June 25 2014
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032