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.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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).

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Other: No Radiation
    No radiotherapy given

Recruiting Locations

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Site Public Contact
210-450-3800
phoresearchoffice@uthscsa.edu

More Details

NCT ID
NCT03488693
Status
Recruiting
Sponsor
Canadian Cancer Trials Group

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.