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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Arm | Active Comparator | Investigational treatment: Arimidex commenced before and continued during radiotherapy. Interventions: 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Other serum inflammatory cytokine |
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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:
No presence of metastatic disease
No other malignant tumour
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayi Chen, MD | Contact | 862164175590 | 6602 |
| Name | Affiliation | Role |
|---|---|---|
| Jiayi Chen, MD | The Department of Radiation Oncology, Fudan University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003966 | Camurati-Engelmann Syndrome |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
|
| 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. |
|
|
| 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 |
|
|
| 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 |
|
|
Pre-and post-radiotherapy other serum inflammatory cytokine |
| First analysis will occur 1 year after first subject enrolled |
| Cosmetic outcomes | Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms. | First analysis will occur 1 year after first subject enrolled |
| Lung toxicity | Occurrence of grade II or higher radiation-induced lung toxicity. | First analysis will occur 1 year after first subject enrolled |
| Local-regional recurrence | Local-regional recurrence within two arms. | First analysis will occur 1 year after first subject enrolled |
| Correlation between TGF-β1 Change and Clinical Outcomes | The correlation between TGF-β1 change and clinical outcomes will be explored. | First analysis will occur 1 year after first subject enrolled |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |