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NCT03488693

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

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2027-12-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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No Regional Radiotherapy

A. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy

Group Type ACTIVE_COMPARATOR

Radiation

Intervention Type RADIATION

Radiotherapy given

No Radiation

Intervention Type OTHER

No radiotherapy given

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

Group Type ACTIVE_COMPARATOR

Radiation

Intervention Type RADIATION

Radiotherapy given

Interventions

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Radiation

Radiotherapy given

Intervention Type RADIATION

No Radiation

No radiotherapy given

Intervention Type OTHER

Eligibility Criteria

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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.
* Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT.
* Patients may or may not have had adjuvant chemotherapy.
* RT must commence within 16 weeks of definitive surgery if the patient is not treated with chemotherapy. If adjuvant chemotherapy is given, RT must begin within 12 weeks after the last dose. (Note: adjuvant chemotherapy may be ongoing at the time of randomization). Definitive surgery is defined as the last breast cancer-related surgery.
* Patient's ECOG performance status must be 0, 1 or 2.
* Patient's age must be ≥ 35 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 (note: enrollment completed 2022Aug02)
* 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 6 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 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).

Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Whelan

Role: STUDY_CHAIR

Juravinski Cancer Centre at Hamilton Health Sciences, Ontario Canada

Identifier Type: OTHER

Identifier Source: secondary_id

CCTG MA.39

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

No Regional Radiotherapy

Radiation

No Radiation

Regional Radiotherapy

Radiation

Interventions

Radiation

No Radiation

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Alliance for Clinical Trials in Oncology

Eastern Cooperative Oncology Group

NRG Oncology

SWOG Cancer Research Network

Canadian Cancer Trials Group

Responsible Party

Principal Investigators

Timothy Whelan

Locations

Fairbanks Memorial Hospital

University of Arizona Cancer Center-Orange Grove Campus

University of Arizona Cancer Center-North Campus

University of Arkansas for Medical Sciences

Kaiser Permanente-Anaheim

Kaiser Permanente-Bellflower

Alta Bates Summit Medical Center-Herrick Campus

City of Hope Corona

City of Hope Comprehensive Cancer Center

Kaiser Permanente Dublin

UC San Diego Health System - Encinitas

Fresno Cancer Center

City of Hope at Irvine Lennar

UC San Diego Moores Cancer Center

City of Hope Antelope Valley

Kaiser Permanente Los Angeles Medical Center

Los Angeles General Medical Center

USC / Norris Comprehensive Cancer Center

Providence Queen of The Valley

Kaiser Permanente Oakland-Broadway

Kaiser Permanente-Ontario

Saint Joseph Hospital - Orange

UC Irvine Health/Chao Family Comprehensive Cancer Center

Desert Regional Medical Center

Kaiser Permanente-Rancho Cordova Cancer Center

Rohnert Park Cancer Center

The Permanente Medical Group-Roseville Radiation Oncology

Mercy Cancer Center - Sacramento

Kaiser Permanente Medical Center - Santa Clara

Saint John's Cancer Institute

City of Hope South Pasadena

Kaiser Permanente Cancer Treatment Center

Saint Helena Hospital

City of Hope South Bay

City of Hope Upland

Sutter Solano Medical Center/Cancer Center

BASS Medical Group - Lennon

UCHealth University of Colorado Hospital

Rocky Mountain Cancer Centers-Boulder

Penrose-Saint Francis Healthcare

UCHealth Memorial Hospital Central

Memorial Hospital North

Saint Francis Cancer Center

UCHealth - Cherry Creek

AdventHealth Porter

Poudre Valley Hospital

Lutheran Hospital - Cancer Centers of Colorado

Banner North Colorado Medical Center

UCHealth Greeley Hospital

UCHealth Highlands Ranch Hospital

AdventHealth Littleton