Clinical trial · Interventional
Study of Arimidex and Radiotherapy Sequencing
A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer
NCT01402193CI-TRIAL-00014929unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post radiotherapy commencement of Arimidex | Drug | — | UNRESOLVED |
| Pre-radiotherapy commencement of Arimidex | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Study Arm
- description
- Investigational treatment: Arimidex commenced before and continued during radiotherapy. Interventions: Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy
- interventionNames
- Drug: Pre-radiotherapy commencement of Arimidex
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy Interventions: Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex
- interventionNames
- Drug: Post radiotherapy commencement of Arimidex
- Radiation: Radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.