Study of Arimidex and Radiotherapy Sequencing

• Status: Unknown status
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborator: AstraZeneca
• Treatments: Anastrozole

Criteria

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