STARS Breast Trial (Study of Anastrozole and Radiotherapy Sequencing)

This study is currently recruiting participants.
Verified July 2013 by Trans-Tasman Radiation Oncology Group (TROG)
Sponsor:
Information provided by (Responsible Party):
Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier:
NCT00887380
First received: April 23, 2009
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Pre-radiotherapy commencement of anastrozole
Radiation: Radiotherapy
Drug: Post radiotherapy commencement of anastrozole
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 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.

Resource links provided by NLM:


Further study details as provided by Trans-Tasman Radiation Oncology Group (TROG):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of distant failure [ Time Frame: 10 years post radiotherapy ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 10 years post radiotherapy ] [ Designated as safety issue: No ]
  • Normal tissue complications [ Time Frame: 10 years post radiotherapy ] [ Designated as safety issue: No ]
  • Cosmesis [ Time Frame: 10 years post radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: September 2009
Estimated Study Completion Date: December 2024
Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A: Concurrent
Investigational treatment: Anastrozole commenced before (Pre-radiotherapy commencement of anastrozole) and continued during radiotherapy.
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
Active Comparator: Arm B: Sequential
Standard Treatment: Anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy (Post radiotherapy commencement of anastrozole)
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

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%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00887380

Contacts
Contact: Peter Graham +61 2 9113 3934 Peter.Graham@sesiahs.health.nsw.gov.au
Contact: Helen Cox +61 2 9113 1922

  Show 33 Study Locations
Sponsors and Collaborators
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
Study Chair: Peter Graham, MBBS Trans-Tasman Radiation Oncology Group (TROG)
  More Information

Additional Information:
No publications provided

Responsible Party: Trans-Tasman Radiation Oncology Group (TROG)
ClinicalTrials.gov Identifier: NCT00887380     History of Changes
Other Study ID Numbers: TROG 08.06, ACTRN12610000307000
Study First Received: April 23, 2009
Last Updated: July 31, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Trans-Tasman Radiation Oncology Group (TROG):
Breast Cancer
Timing of Radiotherapy
Local control

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogen Antagonists
Estrogen Receptor Modulators
Estrogens
Anastrozole
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014