Study of Arimidex and Radiotherapy Sequencing

• Acute skin reaction [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: No ]
  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.
• Other serum inflammatory cytokine [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: No ]
  Pre-and post-radiotherapy other serum inflammatory cytokine
• Cosmetic outcomes [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: No ]
  Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms.
• Lung toxicity [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: No ]
  Occurrence of grade II or higher radiation-induced lung toxicity.
• Local-regional recurrence [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: Yes ]
  Local-regional recurrence within two arms.
• Correlation between TGF-β1 Change and Clinical Outcomes [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: No ]
  The correlation between TGF-β1 change and clinical outcomes will be explored.

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.

• Drug: Pre-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.
  Other Name: Anastrozole
• Drug: Post 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.
  Other Name: Anastrozole
• Radiation: Radiotherapy
  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
  Other Name: RT, Radiation Therapy

• Active Comparator: Study Arm

  Investigational treatment: Arimidex commenced before and continued during radiotherapy.

  Interventions:

  Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy

  Interventions:

  • Drug: Pre-radiotherapy commencement of Arimidex
  • Radiation: Radiotherapy
• Active Comparator: Control Arm

  Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy

  Interventions:

  Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex

  Interventions:

  • Drug: Post radiotherapy commencement of Arimidex
  • Radiation: Radiotherapy

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