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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 : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Canadian Cancer Trials Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Radiation Other: No Radiation Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 2140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : September 1, 2027
Estimated Study Completion Date : December 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: No Regional Radiotherapy
A. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy
Radiation: Radiation
Radiotherapy given

Other: No Radiation
No radiotherapy given

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
Radiation: Radiation
Radiotherapy given




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. Compare the breast cancer mortality between patients that received regional RT or not. [ Time Frame: 9.5 years ]
    Defined as death due to BC

  3. 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

  4. 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

  5. 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

  6. Number and severity of adverse events using the current CTCAE version 4 [ Time Frame: 9.5 years ]
  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488693


Contacts
Contact: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Jeffrey Q. Cao    555 555-5555      
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Susan Chafe    780 432-8518      
Canada, British Columbia
BCCA - Cancer Centre for the Southern Interior Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Angela Lin    250 712-3979      
BCCA - Centre for the North Not yet recruiting
Prince George, British Columbia, Canada, V2M 7E9
Contact: Robert Olson    250 645-7300 ext 687489      
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Alan Nichol    604 877-6000 ext 2658      
BCCA - Vancouver Island Cancer Centre Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Tanya Berrang    250 519-5500 ext 3584      
Canada, Nova Scotia
QEII Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Wladyslawa Cwajna    902 473-6018      
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Timothy J. Whelan    905 387-9495      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Francisco Perera    519 685-8500 ext 53619      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Lynn Chang    613 737-7700 ext 25395      
Niagara Health System Recruiting
St. Catharines, Ontario, Canada, L2S 0A9
Contact: Abhirami Hallock    905 684-7271 ext 43801      
Health Sciences North Not yet recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Julie L. Bowen    705 522-6237 ext 2144      
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Eileen Rakovitch    416 480-4974      
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Anne Koch    416 946-4501 ext 2125      
Canada, Quebec
Hopital de la Cite-de-la-Sante Recruiting
Laval, Quebec, Canada, H7M 3L9
Contact: Isabelle Roy    450 668-1010 ext 24692      
The Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Thierry M. Muanza    514 340-8288      
The Research Institute of the McGill University Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Tarek Hijal    514 934-8040 ext 48040      
CHUQ-Pavillon Hotel-Dieu de Quebec Recruiting
Quebec City, Quebec, Canada, G1R 2J6
Contact: Valerie Theberge    418 691-5264      
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Sawyna Provencher    819 346-1110 ext 13622      
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Derek Suderman    306 766-2488      
Sponsors and Collaborators
Canadian Cancer Trials Group
Investigators
Study Chair: Timothy Whelan Juravinski Cancer Centre at Hamilton Health Sciences, Ontario Canada

Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT03488693     History of Changes
Other Study ID Numbers: MA39
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases