Clinical trial NCT01402193: Study of Arimidex and Radiotherapy Sequencing
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Timing of Radiotherapy
TGF-beta1
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2011-07-26
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Level of TGF-β1
timeFrame: First analysis will occur 1 year after first subject enrolled
Secondary outcomes:
measure: Acute skin reaction
timeFrame: First analysis will occur 1 year after first subject enrolled
measure: Other serum inflammatory cytokine
timeFrame: First analysis will occur 1 year after first subject enrolled
measure: Cosmetic outcomes
timeFrame: First analysis will occur 1 year after first subject enrolled
measure: Lung toxicity
timeFrame: First analysis will occur 1 year after first subject enrolled
measure: Local-regional recurrence
timeFrame: First analysis will occur 1 year after first subject enrolled
measure: Correlation between TGF-β1 Change and Clinical Outcomes
timeFrame: First analysis will occur 1 year after first subject enrolled
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: The Department of Radiation Oncology, Fudan University Cancer Hospital
name: Jiayi Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: