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Study of Arimidex and Radiotherapy Sequencing

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pre-radiotherapy commencement of Arimidex
Post radiotherapy commencement of Arimidex
Radiotherapy
Radiotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Timing of Radiotherapy, TGF-beta1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study Arm

Control Arm

Arm Description

Investigational treatment: Arimidex commenced before and continued during radiotherapy. Interventions: Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy

Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy Interventions: Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Other serum inflammatory cytokine
Pre-and post-radiotherapy other serum inflammatory cytokine
Cosmetic outcomes
Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms.
Lung toxicity
Occurrence of grade II or higher radiation-induced lung toxicity.
Local-regional recurrence
Local-regional recurrence within two arms.
Correlation between TGF-β1 Change and Clinical Outcomes
The correlation between TGF-β1 change and clinical outcomes will be explored.

Full Information

First Posted
July 25, 2011
Last Updated
June 24, 2014
Sponsor
Fudan University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01402193
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Timing of Radiotherapy, TGF-beta1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Arm
Arm Type
Active Comparator
Arm Description
Investigational treatment: Arimidex commenced before and continued during radiotherapy. Interventions: Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy Interventions: Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex
Intervention Type
Drug
Intervention Name(s)
Pre-radiotherapy commencement of Arimidex
Other Intervention Name(s)
Anastrozole
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Post radiotherapy commencement of Arimidex
Other Intervention Name(s)
Anastrozole
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
RT, Radiation Therapy
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
RT, Radiation Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Level of TGF-β1
Description
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.
Time Frame
First analysis will occur 1 year after first subject enrolled
Secondary Outcome Measure Information:
Title
Acute skin reaction
Description
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.
Time Frame
First analysis will occur 1 year after first subject enrolled
Title
Other serum inflammatory cytokine
Description
Pre-and post-radiotherapy other serum inflammatory cytokine
Time Frame
First analysis will occur 1 year after first subject enrolled
Title
Cosmetic outcomes
Description
Cosmetic outcomes in patients receiving breast conservative therapy treated by both arms.
Time Frame
First analysis will occur 1 year after first subject enrolled
Title
Lung toxicity
Description
Occurrence of grade II or higher radiation-induced lung toxicity.
Time Frame
First analysis will occur 1 year after first subject enrolled
Title
Local-regional recurrence
Description
Local-regional recurrence within two arms.
Time Frame
First analysis will occur 1 year after first subject enrolled
Title
Correlation between TGF-β1 Change and Clinical Outcomes
Description
The correlation between TGF-β1 change and clinical outcomes will be explored.
Time Frame
First analysis will occur 1 year after first subject enrolled

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiayi Chen, MD
Phone
862164175590
Ext
6602
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiayi Chen, MD
Organizational Affiliation
The Department of Radiation Oncology, Fudan University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiayi Chen, MD
Phone
862164175590
Ext
6602
First Name & Middle Initial & Last Name & Degree
Jiayi Chen, MD

12. IPD Sharing Statement

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Study of Arimidex and Radiotherapy Sequencing

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