Study of Arimidex and Radiotherapy Sequencing

Phase 3

• Conditions: Breast Cancer
• Interventions: Drug: Pre-radiotherapy commencement of Arimidex; Drug: Post radiotherapy commencement of Arimidex; Radiation: Radiotherapy

• Registration Number: NCT01402193
• Lead Sponsor: Fudan University

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 elevation of TGF-β1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-25
• Primary Completion: 2014-12
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Arm	Pre-radiotherapy commencement of Arimidex	Investigational treatment: Arimidex commenced before and continued during radiotherapy. Interventions: Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy
Study Arm	Radiotherapy	Investigational treatment: Arimidex commenced before and continued during radiotherapy. Interventions: Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy
Control Arm	Post radiotherapy commencement of Arimidex	Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy Interventions: Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex
Control Arm	Radiotherapy	Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy Interventions: Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex

Primary Outcome Measures

Name	Time	Method
Level of TGF-β1	First analysis will occur 1 year after first subject enrolled	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.

Secondary Outcome Measures

Name	Time	Method
Acute skin reaction	First analysis will occur 1 year after first subject enrolled	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	First analysis will occur 1 year after first subject enrolled	Pre-and post-radiotherapy other serum inflammatory cytokine
Lung toxicity	First analysis will occur 1 year after first subject enrolled	Occurrence of grade II or higher radiation-induced lung toxicity.
Cosmetic outcomes	First analysis will occur 1 year after first subject enrolled	Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms.
Local-regional recurrence	First analysis will occur 1 year after first subject enrolled	Local-regional recurrence within two arms.
Correlation between TGF-β1 Change and Clinical Outcomes	First analysis will occur 1 year after first subject enrolled	The correlation between TGF-β1 change and clinical outcomes will be explored.

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China