Study of Arimidex and Radiotherapy Sequencing

NCT01402193 | Unknown Phase 3 DMC

• 1 other identifier: BR-RT-002
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

Breast Cancer; Timing of Radiotherapy; TGF-beta1

Outcome Measures

Primary Outcomes (1)

• Level of TGF-β1

  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.

  First analysis will occur 1 year after first subject enrolled

Secondary Outcomes (6)

• Acute skin reaction

  First analysis will occur 1 year after first subject enrolled

• Other serum inflammatory cytokine

  First analysis will occur 1 year after first subject enrolled

• Cosmetic outcomes

  First analysis will occur 1 year after first subject enrolled

• Lung toxicity

  First analysis will occur 1 year after first subject enrolled

• Local-regional recurrence

  First analysis will occur 1 year after first subject enrolled

Study Arms (2)

Study Arm

ACTIVE COMPARATOR

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

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

Control Arm

ACTIVE COMPARATOR

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

Drug: Post radiotherapy commencement of Arimidex; Radiation: Radiotherapy

Interventions

Pre-radiotherapy commencement of Arimidex 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.

Also known as: Anastrozole

Study Arm

Post radiotherapy commencement of Arimidex 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.

Also known as: Anastrozole

Control Arm

Radiotherapy 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

Also known as: RT, Radiation Therapy

Study Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• AstraZeneca: collaborator

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Camurati-Engelmann Syndrome

Interventions

Anastrozole; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Jiayi Chen, MD

  The Department of Radiation Oncology, Fudan University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiayi Chen, MD

CONTACT

862164175590

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Vice Chairman of Department of Radiation Oncology

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: June 25, 2014

Record last verified: 2014-06

Locations

CN (1)