Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

  • STATUS
    Recruiting
  • End date
    Dec 30, 2027
  • participants needed
    2140
  • sponsor
    Canadian Cancer Trials Group
Updated on 14 April 2021
carcinoma
endocrine therapy
metastasis
hormone therapy
HER2
erbb2
mastectomy
adjuvant chemotherapy
axillary lymph node dissection
immunostimulant
breast-conserving surgery
sentinel lymph node biopsy
invasive carcinoma

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.

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.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Radiation, No Radiation
Clinical Study IdentifierNCT03488693
SponsorCanadian Cancer Trials Group
Last Modified on14 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 40 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or cancer, breast or breast carcinoma or Breast Cancer Diagnosis?
Do you have any of these conditions: Breast Cancer Diagnosis or Breast Cancer or breast carcinoma or cancer, breast?
Do you have any of these conditions: Breast Cancer Diagnosis or cancer, breast or breast carcinoma or Breast Cancer?
Do you have any of these conditions: cancer, breast or Breast Cancer Diagnosis or breast carcinoma or Breast Cancer?
Do you have any of these conditions: Breast Cancer or Breast Cancer Diagnosis or breast carcinoma or cancer, breast?
Do you have any of these conditions: breast carcinoma or Breast Cancer or cancer, breast or Breast Cancer Diagnosis?
Do you have any of these conditions: cancer, breast or Breast Cancer Diagnosis or breast carcinoma or Breast Cancer?
Do you have any of these conditions: Breast Cancer or Breast Cancer Diagnosis or cancer, breast or breast carcinoma?
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)
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