Study of Arimidex and Radiotherapy Sequencing

Breast Cancer Clinical Trial

Official title:

A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01402193
• Other study ID #: BR-RT-002
• Status: Recruiting
• Phase: Phase 3
• First received: July 25, 2011
• Last updated: June 24, 2014
• Start date: July 2011
• Est. completion date: July 2015

Study information

• Verified date: June 2014
• Source: Fudan University
• Contact: Jiayi Chen, MD
• Phone: 862164175590
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

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
• 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

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Fudan University	AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of TGF-ß1	To compare TGF-ß1 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-ß1 level at the 4th week after initiation of radiotherapy relative to the pre-treatment baseline.	First analysis will occur 1 year after first subject enrolled	No
Secondary	Acute skin reaction	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.	First analysis will occur 1 year after first subject enrolled	No
Secondary	Other serum inflammatory cytokine	Pre-and post-radiotherapy other serum inflammatory cytokine	First analysis will occur 1 year after first subject enrolled	No
Secondary	Cosmetic outcomes	Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms.	First analysis will occur 1 year after first subject enrolled	No
Secondary	Lung toxicity	Occurrence of grade II or higher radiation-induced lung toxicity.	First analysis will occur 1 year after first subject enrolled	No
Secondary	Local-regional recurrence	Local-regional recurrence within two arms.	First analysis will occur 1 year after first subject enrolled	Yes
Secondary	Correlation between TGF-ß1 Change and Clinical Outcomes	The correlation between TGF-ß1 change and clinical outcomes will be explored.	First analysis will occur 1 year after first subject enrolled	No