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Trial record 1 of 1 for:    NCT00887380
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STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing) (STARS)

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ClinicalTrials.gov Identifier: NCT00887380
Recruitment Status : Active, not recruiting
First Posted : April 24, 2009
Last Update Posted : November 18, 2022
Sponsor:
Information provided by (Responsible Party):
Trans Tasman Radiation Oncology Group

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 24, 2009
Last Update Posted Date November 18, 2022
Actual Study Start Date  ICMJE September 16, 2009
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
To determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy. [ Time Frame: 10 years post radiotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2009)
  • Rates of distant failure [ Time Frame: 10 years post radiotherapy ]
  • Overall Survival [ Time Frame: 10 years post radiotherapy ]
  • Normal tissue complications [ Time Frame: 10 years post radiotherapy ]
  • Cosmesis [ Time Frame: 10 years post radiotherapy ]
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 STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)
Official Title  ICMJE A Randomised Comparison of Anastrozole Commenced Before and Continued During Adjuvant Radiotherapy for Breast Cancer Versus Anastrozole and Subsequent Anti-oestrogen Therapy Delayed Until After Radiotherapy.
Brief Summary The purpose of this study is to determine whether starting anastrozole prior to radiotherapy, so that it is taken during radiotherapy, decreases local recurrence of breast cancer in post-menopausal women in comparison to waiting until after radiotherapy to commence anastrozole.
Detailed Description

Adjuvant radiotherapy is well established as the primary modality to enhance local control in breast cancer. The use of adjuvant hormone therapy such as tamoxifen has shown to improve local control to a relatively minor amount on its own and does enhance local control of adjuvant radiotherapy. There is, however, conflicting invitro and clinical data regarding the effects or different sequences on tamoxifen and radiotherapy in terms of both local control and enhancement of radiotherapy toxicities.

Aromatase inhibitors such as anastrozole are establishing themselves as a class of drug superior to tamoxifen for the control of estrogen dependent breast cancers and overall are better tolerated with the exception of greater bone loss.

As the key question is whether the sequencing of the aromatase inhibitor anastrozole alters local control by acting as an enhancer of the radiation breast cancer cell kill, it is therefore the aim of this study to compare 3 months of anastrozole prior to radiotherapy versus 3 months of anastrozole after radiotherapy with a specific objective of reducing the baseline ratio of in-field radiotherapy failure from 6% to 3%.

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 anastrozole
    Anastrozole: 1mg per day will be prescribed for 12 weeks. Commencing within 1 week of randomisation, to be administered from a min of 1 week before and a max of 4 weeks before commencement of radiotherapy and continued throughout radiotherapy. After 12 weeks administration of anastrozole according to trial regimen, anastrozole can be continued at the treating clinician's discretion and in accordance with the preference selected at the time of randomisation and stratification. The alternative options to long-term anastrozole are tamoxifen or cessation of anti-oestrogen therapy.
    Other Name: Arimidex
  • Radiation: Radiotherapy
    Radiotherapy must commence within 1 month of randomisation. Radiotherapy planning and treatment is as per the protocol.
    Other Name: RT, Radiation Therapy
  • Drug: Post radiotherapy commencement of anastrozole
    Anastrozole 1mg per day will be prescribed for 12 weeks after radiotherapy is completed. Anastrozole should commence within 1 week of the last fraction of radiotherapy and be continued for a total of 12 weeks. After 12 weeks administration according to the trial regimen, any subsequent hormone therapy is as for the concurrent arm.
    Other Name: Arimidex
Study Arms  ICMJE
  • Active Comparator: Arm A: Concurrent
    Investigational treatment: Anastrozole commenced before (Pre-radiotherapy commencement of anastrozole) and continued during radiotherapy.
    Interventions:
    • Drug: Pre-radiotherapy commencement of anastrozole
    • Radiation: Radiotherapy
  • Active Comparator: Arm B: Sequential
    Standard Treatment: Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy (Post radiotherapy commencement of anastrozole)
    Interventions:
    • Radiation: Radiotherapy
    • Drug: Post radiotherapy commencement of anastrozole
Publications * Browne LH, Graham PH. Good intentions and ICH-GCP: Trial conduct training needs to go beyond the ICH-GCP document and include the intention-to-treat principle. Clin Trials. 2014 Dec;11(6):629-34. doi: 10.1177/1740774514542620. Epub 2014 Jul 14.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 22, 2017)
2023
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2009)
2000
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women aged 18 years or older
  • Post total mastectomy or lumpectomy. All planned cancer resection surgery complete.
  • Histologic or pathologic reports must verify either:

    • No tumour contacting the inked margin of surgically removed tissue, or
    • Focal involvement (<2mm front) if the margin is at the deep (posterior part) of the breast and the surgeon confirms that surgery extended to the deep fascia, or
    • Focal involvement (<2mm front) if the margin is superficial (anterior part of the breast or subcutaneous) and the surgeon confirms that surgery extended to the subcutis NB: In the case of focally involved deep or superficial margins, the medical records or multidisciplinary meeting notes or correspondence from the surgeon must indicate that the surgeon confirms the surgery extended to the deep fascia or subcutis as appropriate. Patients should routinely receive a lumpectomy bed boost in the conserved breast setting if there is focal superficial or focal deep involvement as defined above.
  • Tumour oestrogen receptor and/or progesterone receptor positive (≥10% cells positive).
  • Radiotherapy not yet commenced
  • Planned radiotherapy dose prescribed to ICRU reference points in the irradiated breast / chest wall volumes at least the biological equivalent of 45 Gy in 25 fractions or more. (BED Gy4 ≥ 65, BED Gyx=D(1+n/x) where D=total dose, n=dose per fraction, x=alpha beta ratio, Gy4 selected as appropriate alpha-beta ratio for human breast cancer lines)
  • An ECOG performance status score of 2 or less.
  • Female and post menopausal shown by satisfying at least one of the following criteria (as per the ATAC study criteria16):

    • bilateral oophorectomy
    • age greater than 60
    • age 45-59 years with intact uterus and amenorrhoeic at least 12 months
    • Amenorrhoeic less than 12 months with follicle stimulating hormone (FSH) levels within the post menopausal range (including patients with amenorrhoea due to chemotherapy, LHRH use or who have had hormone replacement following hysterectomy) Note: it is recommended for women under the age of 45 who have been rendered menopausal by chemotherapy that they be enrolled onto the strata which switches to Tamoxifen after the initial 3 months of anastrozole.
  • Is not receiving chemotherapy, or is receiving chemotherapy but the course will be completed at least 3 weeks prior to commencing radiotherapy
  • Unilateral treatment
  • Has provided written informed consent for participation in this trial

Exclusion Criteria:

  • Previous radiotherapy to the area to be treated
  • Previous invasive malignancy within 5 years of current breast cancer diagnosis with the exception of cervix in-situ or skin cancer other than melanoma.
  • Patients with clinical evidence of metastatic disease.
  • Previous hormonal breast cancer therapy.
  • Ongoing hormone replacement therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (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 Australia,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00887380
Other Study ID Numbers  ICMJE TROG 08.06
ACTRN12610000307000 ( Registry Identifier: ANZCTR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Trans Tasman Radiation Oncology Group
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Trans Tasman Radiation Oncology Group
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Peter Graham, MBBS Trans Tasman Radiation Oncology Group
PRS Account Trans Tasman Radiation Oncology Group
Verification Date November 2022

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