Clinical Trials /

Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

NCT03488693

Description:

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
  • Official Title: TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: MA39
  • NCT ID: NCT03488693

Conditions

  • Breast Cancer

Purpose

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

Detailed Description

      Women with node positive breast cancer normally will receive endocrine therapy and some may
      receive chemotherapy to help prevent the cancer from coming back. Many women will also
      receive radiotherapy to the whole breast/chest area and the surrounding lymph glands (called
      regional radiotherapy). No one really knows whether patients with low risk breast cancer need
      to receive regional radiotherapy. Some women may be getting regional radiotherapy who do not
      need it. These women may be exposed to the side effects of their treatment without benefit.
    

Trial Arms

NameTypeDescriptionInterventions
No Regional RadiotherapyActive ComparatorA. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy
    Regional RadiotherapyActive ComparatorA. WBI plus RT to the regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following BCS or; B. RT to the chestwall and regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following mastectomy

      Eligibility Criteria

              Inclusion Criteria:
      
                -  Patients must have newly diagnosed histologically proven invasive carcinoma of the
                   breast with no evidence of metastases.
      
                -  Patients must have been treated by BCS or mastectomy.
      
                -  Patients treated by BCS or mastectomy and axillary dissection must have 1-3 positive
                   axillary nodes (macrometastases, > 2 mm).
      
                -  Patients treated by BCS and SLNB alone must have only 1-2 positive axillary nodes
                   (macrometastases, > 2 mm).
      
                -  Patients treated by mastectomy and SLNB alone must have only 1 positive axillary node
                   (macrometastases, > 2 mm).
      
                -  Patients must be ER ≥ 1% and HER2 negative on local testing
      
                -  Patients must have an Oncotype DX recurrence score <18
      
                -  Patient must consent to provision of, and investigator(s) must confirm access to and
                   agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed
                   paraffin block of tumour tissue in order that the specific correlative marker assays
                   described in the protocol may be conducted
      
                -  Patient must consent to provision of samples of blood in order that the specific
                   correlative marker assays described in the protocol may be conducted.
      
                -  Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Endocrine
                   therapy can be given concurrently or following RT.
      
                -  Patients may or may not have had adjuvant chemotherapy.
      
                -  RT must be administered within 12 weeks of definitive surgery if the patient is not
                   treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 2-8
                   weeks after the last dose.
      
                -  Patient's ECOG performance status must be 0, 1 or 2.
      
                -  Patient's age must be ≥ 40 years.
      
                -  Patient's life expectancy is ≥10 years
      
                -  For the first 736 eligible English or French-speaking subjects who have agreed to
                   optional questionnaire completion: Patient is able (i.e. sufficiently fluent) and
                   willing to complete the quality of life, health utilities and lost productivity
                   questionnaires in either English or French
      
                -  Patient consent must be appropriately obtained in accordance with applicable local and
                   regulatory requirements
      
                -  Patients must be accessible for treatment and follow-up. Investigators must assure
                   themselves the patients randomized on this trial will be available for complete
                   documentation of the treatment, adverse events, and follow-up.
      
                -  In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of
                   patient randomization.
      
                -  Women of childbearing potential must have agreed to use an effective contraceptive
                   method. A woman is considered to be of "childbearing potential" if she has had menses
                   at any time in the preceding 12 consecutive months.
      
              Exclusion Criteria:
      
                -  Patients with nodal disease limited to micrometastases (pN1Mi, > 0.2 mm and ≤ 2 mm) or
                   isolated tumour cells (pN0i+ < 0.2 mm).
      
                -  Any prior history, not including the index cancer, of ipsilateral invasive breast
                   cancer or ipsilateral DCIS treated with radiation therapy. (Patients with synchronous
                   or previous ipsilateral LCIS are eligible.)
      
                -  Synchronous or previous contralateral invasive breast cancer. (Patients with
                   contralateral DCIS not treated with radiation are eligible.)
      
                -  History of non-breast malignancies except adequately treated non-melanoma skin
                   cancers, in situ cancers treated by local excision or other cancers curatively treated
                   with no evidence of disease for ≥ 5 years.
      
                -  Patients with pT3 or pT4 disease.
      
                -  Patients who are pregnant.
      
                -  Patients that have had prior ipsilateral chestwall/thoracic radiation.
      
                -  Patients treated with neoadjuvant chemo or endocrine therapy for breast cancer.
      
                -  Patients with serious non-malignant disease (e.g. cardiovascular, scleroderma etc.)
                   which would preclude RT.
      
                -  Patients with any serious active or co-morbid medical conditions, laboratory
                   abnormality, psychiatric illness, active or uncontrolled infections, or serious
                   illnesses or medical conditions that would prevent the patient from participating or
                   to be managed according to the protocol (according to investigator's decision).
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:40 Years
      Eligible Gender:Female
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not
      Time Frame:9.5 years
      Safety Issue:
      Description:Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.

      Secondary Outcome Measures

      Measure:Compare the invasive disease-free survival between patients that received regional RT or not.
      Time Frame:9.5 years
      Safety Issue:
      Description:Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC
      Measure:Compare the breast cancer mortality between patients that received regional RT or not.
      Time Frame:9.5 years
      Safety Issue:
      Description:Defined as death due to BC
      Measure:Compare the overall survival (OS) between patients that received regional RT or not
      Time Frame:9.5 years
      Safety Issue:
      Description:Defined as the time from randomization to the time of death from any cause
      Measure:Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not.
      Time Frame:9.5 years
      Safety Issue:
      Description:Defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast or regional nodes, or death to due to BC
      Measure:Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not.
      Time Frame:9.5 years
      Safety Issue:
      Description:Defined as time from randomization to time of invasive recurrent disease in distant sites or death due to BC
      Measure:Number and severity of adverse events using the current CTCAE version 4
      Time Frame:9.5 years
      Safety Issue:
      Description:
      Measure:Compare arm volume and mobility measurements between patients that received regional RT or not
      Time Frame:9.5 years
      Safety Issue:
      Description:A Fisher's Exact Test will be used to compare lymphedema and arm abduction deficit between two arms. Defined as a difference in arm abduction of 10% or greater in the comparison of the ipsilateral to the contralateral arm.
      Measure:Compare patient-reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not
      Time Frame:9.5 years
      Safety Issue:
      Description:using the NSABP Questionnaire for patients treated by BCS or mastectomy.
      Measure:Compare the quality of life (QOL) between patients that received regional RT or not
      Time Frame:9.5 years
      Safety Issue:
      Description:Overall QOL (EORTC QLQ-C30) will be compared between the two treatment groups using a similar approach.
      Measure:Compare the cost-effectiveness between patients that received regional RT or not
      Time Frame:9.5 years
      Safety Issue:
      Description:Costs will be expressed in $US and $CAN base currencies based on the final year of the study. An average cost per study subject by treatment arm for an overall mean cost per study arm will be generated
      Measure:Compare the quality of life (QOL) between patients that received regional RT or not
      Time Frame:9.5 years
      Safety Issue:
      Description:breast symptoms (NSABP B32 Questionnaire) will be compared between the two treatment groups using a similar approach.
      Measure:Compare the quality of life (QOL) between patients that received regional RT or not
      Time Frame:9.5 years
      Safety Issue:
      Description:skin symptoms and fatigue (EORTC QLQ-BR23) will be compared between the two treatment groups using a similar approach.

      Details

      Phase:Phase 3
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Canadian Cancer Trials Group

      Last Updated

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