Study of Arimidex and Radiotherapy Sequencing

NCT ID: NCT01402193

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-07-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Arm

Investigational treatment: Arimidex commenced before and continued during radiotherapy.

Interventions:

Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy

Group Type: ACTIVE_COMPARATOR

Pre-radiotherapy commencement of Arimidex

Intervention Type: DRUG

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.

Radiotherapy

Intervention Type: RADIATION

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

Control Arm

Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy

Interventions:

Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex

Group Type: ACTIVE_COMPARATOR

Post radiotherapy commencement of Arimidex

Intervention Type: DRUG

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.

Radiotherapy

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

Intervention Type: 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

Intervention Type: RADIATION

Other Intervention Names

Anastrozole; Anastrozole; RT, Radiation Therapy; RT, Radiation Therapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jiayi Chen

Associate Professor, Vice Chairman of Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiayi Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The Department of Radiation Oncology, Fudan University Cancer Hospital

Locations

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiayi Chen, MD

Role: CONTACT

862164175590 ext. 6602

Facility Contacts

Jiayi Chen, MD

Role: primary

862164175590 ext. 6602

Other Identifiers

BR-RT-002

Identifier Type: -

Identifier Source: org_study_id