Study of Arimidex and Radiotherapy Sequencing

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Radiation: Radiotherapy; Drug: Post radiotherapy commencement of Arimidex; Drug: Pre-radiotherapy commencement of Arimidex

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01402193

BR-RT-002

Details and patient eligibility

About

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.

Enrollment: 220 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Study Arm

Active Comparator group

Description:

Investigational treatment: Arimidex commenced before and continued during radiotherapy. Interventions: Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy

Treatment:

Drug: Pre-radiotherapy commencement of Arimidex

Radiation: Radiotherapy

Radiation: Radiotherapy

Control Arm

Active Comparator group

Description:

Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy Interventions: Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex

Treatment:

Drug: Post radiotherapy commencement of Arimidex

Radiation: Radiotherapy

Radiation: Radiotherapy