Radiotherapy in Early Breast Cancer

Phase 3

Completed

• Conditions: ode positive or high risk node negative early Breast Cancer; Node positive or high risk node negative early Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12606000523505
• Lead Sponsor: ational Cancer Institute of Canada (NCIC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-12-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1822

Inclusion Criteria

Histologically proven invasive carcinoma of the breast and no evidence of metastatic disease.- Investigations, including ER receptor status, and chest x-ray, and any additional investigations to rule out metastatic disease performed within 9 months prior to randomization.- A history and physical exam including weight, performance status and measurement of upper andlower arm circumferences performed within 12 weeks prior to randomization.- A bilateral mammogram performed within 12 months prior to randomization.- Patients must have been treated with Breast conservation therapy (BCT) (eg. lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy and considered a candidate for breast radiation. - Patients must be at high risk of regional recurrence, due to 1) pathologically positive axillary nodes, or2) pathologically negative axillary nodes anda) primary tumor > 5 cm orb) primary tumor > 2 cm and <10 axillary nodes removed and one of the following: ER negative, Skarf-Bloom-Richardson (SBR) grade 3 or lymphovascular invasion.Note: Patients with sentinel node dissection are eligible if they are node negative but still meet thehigh risk criteria. However, if they are node positive, a level I and II axillary dissection must be performed.- Patients must be treated with adjuvant systemic treatment, either currently accepted chemotherapy and/or hormonal therapy. (Patients may also have planned chemotherapy concurrently with theirradiation therapy.)- Performance status must be Eastern Cooperative Onocology Group (ECOG) 0, 1, or 2.- Patients should be planned and started on radiation as soon as possible after randomization.- Protocol treatment (radiotherapy) must begin within 8 weeks of the completion of adjuvant chemotherapy, unless radiotherapy is given concurrently with chemotherapy (ie CMF), or within 16weeks of the last surgical procedure for patients receiving hormonal therapy only.Patient’s life expectancy is >5 years- Women of childbearing potential must be using adequate contraception while receiving radiotherapy.

Exclusion Criteria

Clinical evidence prior to surgery of T4 or N2-3 disease (UICC, 1997)- Evidence of residual disease in the axilla following dissection.- Serious non-malignant disease (e.g., cardiovascular, renal, pulmonary, systemic lupus erythematosis-SLE, scleroderma) which would preclude definitive surgical or radiation treatment.Note: Radiation therapy may not be recommended for patients with connective tissue disorders such as Lupus or Scleroderma.- Currently pregnant or lactating.- Women of childbearing age must be using adequate contraception while on treatment.- Concurrent and previous malignancies except non melanoma skin cancer; carcinoma in situ of the cervix or endometrium; contralateral non-invasive breast cancer (unless previous radiation to the contralateral breast). Also, invasive carcinoma of the cervix, endometrium, colon, thyroid, and melanoma treated five years prior to study entry and presumed cured are permitted on study.- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival[Time from randomisation to the time of death from any cause (final analysis will be done on this outcome when 312 patients have died but they will be followed until death). The rest of the patients will only be followed until death but the information will be analysed at the time of 312 deaths.]

Secondary Outcome Measures

Name	Time	Method
Compare the toxic effects of these regimens in these patients.[ Last week of radiation treatment, 3 and 9 months after the last dose of radiotherapy and then annually (until death). The analysis will be done at the point of 312 deaths but the information will be collected until death of all 1822. ];Compare the quality of life of patients. [Last week of radiation treatment, 3 and 9 months after the last dose of radiotherapy and then annually (until the first distant recurrence).];Compare cosmetic outcomes in patients. [At 33 months (3 yrs) and 57 months (5 yrs) post radiotherapy.]