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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Pre-radiotherapy commencement of Arimidex
Drug: Post radiotherapy commencement of Arimidex
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 220
Study Start Date: July 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study Arm

Investigational treatment: Arimidex commenced before and continued during radiotherapy.

Interventions:

Drug: Pre-radiotherapy commencement of Arimidex Radiation: Radiotherapy

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
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: Control Arm

Standard Treatment: Arimidex delayed until 2 weeks after radiotherapy

Interventions:

Radiation: Radiotherapy Drug: Post radiotherapy commencement of Arimidex

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402193

Contacts
Contact: Jiayi Chen, MD 862164175590 ext 6602

Locations
China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jiayi Chen, MD    862164175590 ext 6602      
Principal Investigator: Jiayi Chen, MD         
Sponsors and Collaborators
Fudan University
AstraZeneca
Investigators
Principal Investigator: Jiayi Chen, MD The Department of Radiation Oncology, Fudan University Cancer Hospital
  More Information

No publications provided

Responsible Party: Jiayi Chen, Associate Professor, Vice Chairman of Department of Radiation Oncology, Fudan University
ClinicalTrials.gov Identifier: NCT01402193     History of Changes
Other Study ID Numbers: BR-RT-002
Study First Received: July 25, 2011
Last Updated: June 24, 2014
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Breast Cancer
Timing of Radiotherapy
TGF-beta1

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014