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Study of Arimidex and Radiotherapy Sequencing

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ClinicalTrials.gov Identifier: NCT01402193
Recruitment Status : Unknown
Verified June 2014 by Jiayi Chen, Fudan University.
Recruitment status was:  Recruiting
First Posted : July 26, 2011
Last Update Posted : June 25, 2014
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Jiayi Chen, Fudan University

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 26, 2011
Last Update Posted Date June 25, 2014
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
Level of TGF-β1 [ Time Frame: First analysis will occur 1 year after first subject enrolled ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • Acute skin reaction [ Time Frame: First analysis will occur 1 year after first subject enrolled ]
    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.
  • Other serum inflammatory cytokine [ Time Frame: First analysis will occur 1 year after first subject enrolled ]
    Pre-and post-radiotherapy other serum inflammatory cytokine
  • Cosmetic outcomes [ Time Frame: First analysis will occur 1 year after first subject enrolled ]
    Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms.
  • Lung toxicity [ Time Frame: First analysis will occur 1 year after first subject enrolled ]
    Occurrence of grade II or higher radiation-induced lung toxicity.
  • Local-regional recurrence [ Time Frame: First analysis will occur 1 year after first subject enrolled ]
    Local-regional recurrence within two arms.
  • Correlation between TGF-β1 Change and Clinical Outcomes [ Time Frame: First analysis will occur 1 year after first subject enrolled ]
    The correlation between TGF-β1 change and clinical outcomes will be explored.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Arimidex and Radiotherapy Sequencing
Official Title  ICMJE A Prospective, Randomized, Bi-center Study to Compare the Outcome of Adjuvant Radiotherapy With Concomitant or Sequential Arimidex in Postmenopausal Women With Breast Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: 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.
    Other Name: Anastrozole
  • 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.
    Other Name: Anastrozole
  • 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
    Other Name: RT, Radiation Therapy
Study Arms  ICMJE
  • Active Comparator: Study Arm

    Investigational treatment: Arimidex commenced before and continued during radiotherapy.

    Interventions:

    Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy

    Interventions:
    • Drug: Pre-radiotherapy commencement of Arimidex
    • Radiation: Radiotherapy
  • Active Comparator: Control Arm

    Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy

    Interventions:

    Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex

    Interventions:
    • Drug: Post radiotherapy commencement of Arimidex
    • Radiation: Radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 25, 2011)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01402193
Other Study ID Numbers  ICMJE BR-RT-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiayi Chen, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE AstraZeneca
Investigators  ICMJE
Principal Investigator: Jiayi Chen, MD The Department of Radiation Oncology, Fudan University Cancer Hospital
PRS Account Fudan University
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP