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Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

TAILOR RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

NCT03488693•Canadian Cancer Trials Group

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.

Eligibility

Age

35 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care.
•Patients must have been treated by BCS or mastectomy with clear margins of excision. Post-mastectomy positive margins for invasive disease and/or DCIS is not allowed. Multifocal disease (i.e. the presence of two or more foci or breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed.
•Patients with T3N0 disease are eligible.
•Patients with disease limited to nodal micrometastases are eligible
•Patients with nodal macrometastases (\>2mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, \> 2 mm).
•Patients treated by mastectomy and SLNB alone must have only 1-2 positive axillary nodes (macrometastases, \> 2 mm).
•Patients must be ER ≥ 1% and HER2 negative on local testing
•Patients must have an Oncotype DX recurrence score ≤25 obtained from testing of breast tumour tissue from a core biopsy or from the surgical specimen.
•Patient must consent to provision of, and investigator(s) must 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.
+10 more criteria

Exclusion Criteria

•Patients with nodal disease limited to isolated tumour cells (pN0i+ \< 0.2 mm).
•Patients with pT3N1 and pT4 disease (Note: patients with T3N0 are eligible).
•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 are eligible unless previously treated with radiation.)
•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 who are pregnant.
•Patients that have had prior ipsilateral chestwall/thoracic radiation.
•Patients treated with chemo or endocrine therapy administered in the neoadjuvant setting for breast cancer. Endocrine therapy exposure 12 weeks or less prior to surgery is permitted.
•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).

Locations (475)

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

City of Hope Corona

Corona, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Key Dates

Start Date

October 16, 2018

Primary Completion Date

September 1, 2027

Completion Date

December 30, 2027

Last Updated

January 13, 2026

Enrollment

2,140

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Radiation

RADIATION

No Radiation

OTHER

Contacts

Wendy Parulekar

CONTACT

613-533-6430 wparulekar@ctg.queensu.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Regional Radiotherapy in Biomarker Low-Risk Node Positive and T3N0 Breast Cancer

Inclusion Criteria

Exclusion Criteria

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