Study of Arimidex and Radiotherapy Sequencing

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Fudan University
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Jiayi Chen, Fudan University
ClinicalTrials.gov Identifier:
NCT01402193
First received: July 25, 2011
Last updated: June 24, 2014
Last verified: June 2014

July 25, 2011
June 24, 2014
July 2011
December 2014   (final data collection date for primary outcome measure)
Level of TGF-β1 [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01402193 on ClinicalTrials.gov Archive Site
  • Acute skin reaction [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pre-and post-radiotherapy other serum inflammatory cytokine
  • Cosmetic outcomes [ Time Frame: First analysis will occur 1 year after first subject enrolled ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    The correlation between TGF-β1 change and clinical outcomes will be explored.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
220
July 2015
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact: Jiayi Chen, MD 862164175590 ext 6602
China
 
NCT01402193
BR-RT-002
Yes
Jiayi Chen, Fudan University
Fudan University
AstraZeneca
Principal Investigator: Jiayi Chen, MD The Department of Radiation Oncology, Fudan University Cancer Hospital
Fudan University
June 2014

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