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Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer (TAILOR RT)

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ClinicalTrials.gov Identifier: NCT03488693
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Alliance for Clinical Trials in Oncology
Eastern Cooperative Oncology Group
NRG Oncology
Southwest Oncology Group
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Tracking Information
First Submitted Date  ICMJE March 28, 2018
First Posted Date  ICMJE April 5, 2018
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE May 30, 2018
Estimated Primary Completion Date September 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not [ Time Frame: 9.5 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03488693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • Compare the invasive disease-free survival between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    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
  • Compare the breast cancer mortality between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    Defined as death due to BC
  • Compare the overall survival (OS) between patients that received regional RT or not [ Time Frame: 9.5 years ]
    Defined as the time from randomization to the time of death from any cause
  • Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    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
  • Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    Defined as time from randomization to time of invasive recurrent disease in distant sites or death due to BC
  • Number and severity of adverse events using the current CTCAE version 4 [ Time Frame: 9.5 years ]
  • Compare arm volume and mobility measurements between patients that received regional RT or not [ Time Frame: 9.5 years ]
    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.
  • Compare patient-reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not [ Time Frame: 9.5 years ]
    using the NSABP Questionnaire for patients treated by BCS or mastectomy.
  • Compare the quality of life (QOL) between patients that received regional RT or not [ Time Frame: 9.5 years ]
    Overall QOL (EORTC QLQ-C30) will be compared between the two treatment groups using a similar approach.
  • Compare the cost-effectiveness between patients that received regional RT or not [ Time Frame: 9.5 years ]
    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
  • Compare the quality of life (QOL) between patients that received regional RT or not [ Time Frame: 9.5 years ]
    breast symptoms (NSABP B32 Questionnaire) will be compared between the two treatment groups using a similar approach.
  • Compare the quality of life (QOL) between patients that received regional RT or not [ Time Frame: 9.5 years ]
    skin symptoms and fatigue (EORTC QLQ-BR23) will be compared between the two treatment groups using a similar approach.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Compare the invasive disease-free survival between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    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
  • Compare the breast cancer mortality between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    Defined as death due to BC
  • Compare the overall survival (OS) between patients that received regional RT or not [ Time Frame: 9.5 years ]
    Defined as the time from randomization to the time of death from any cause
  • Compare the locoregional recurrence-free interval (LRRFI) between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    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
  • Compare the distant recurrence-free interval (DRFI) between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    Defined as time from randomization to time of invasive recurrent disease in distant sites or death due to BC
  • Number and severity of adverse events using the current CTCAE version 4 [ Time Frame: 9.5 years ]
  • Compare arm volume and mobility measurements between patients that received regional RT or not [ Time Frame: 9.5 years ]
    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.
  • Compare patient-reported outcomes (PROs) and the quality of life (QOL) between patients that received regional RT or not [ Time Frame: 9.5 years ]
    using the NSABP Questionnaire for patients treated by BCS or mastectomy.
  • Compare the quality of life (QOL) between patients that received regional RT or not [ Time Frame: 9.5 years ]
    Overall QOL (EORTC QLQ-C30), breast symptoms (NSABP B32 Questionnaire), skin symptoms and fatigue (EORTC QLQ-BR23) will be compared between the two treatment groups using a similar approach.
  • Compare the cost-effectiveness between patients that received regional RT or not [ Time Frame: 9.5 years ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
Official Title  ICMJE TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
Brief Summary 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Radiation: Radiation
    Radiotherapy given
  • Other: No Radiation
    No radiotherapy given
Study Arms  ICMJE
  • Active Comparator: No Regional Radiotherapy
    A. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy
    Interventions:
    • Radiation: Radiation
    • Other: No Radiation
  • Active Comparator: Regional Radiotherapy
    A. 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
    Intervention: Radiation: Radiation
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
2140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2027
Estimated Primary Completion Date September 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca
Listed Location Countries  ICMJE United States,   Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03488693
Other Study ID Numbers  ICMJE CCTG MA.39
NCI-2017-02047 ( Other Identifier: NCI CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Canadian Cancer Trials Group
Study Sponsor  ICMJE Canadian Cancer Trials Group
Collaborators  ICMJE
  • Alliance for Clinical Trials in Oncology
  • Eastern Cooperative Oncology Group
  • NRG Oncology
  • Southwest Oncology Group
Investigators  ICMJE
Study Chair: Timothy Whelan Juravinski Cancer Centre at Hamilton Health Sciences, Ontario Canada
PRS Account Canadian Cancer Trials Group
Verification Date June 2019

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