Breastcancer
Conditions
Keywords
Post-Mastectomy Radiation, Node Negative, Early breast Cancer
Brief summary
Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2 tumors and negative axillary nodes is not generally warranted because of the presumed low risk of recurrence in this population as a whole. However, in the setting of multiple adverse prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of recurrence documented for patients with one to three positive lymph nodes. Numerous retrospective series have reported the outcome and patterns of failure for post-mastectomy patients treated without radiation. Many of these series have analyzed several high risk factors which were predictive of loco-regional recurrence wherein the role of adjuvant post-mastectomy radiation can be considered. Some authors have used combinations of prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and lympho-vascular space invasion to define subgroups with more specific risks of loco-regional recurrence than single factors alone. The current trial hypothesizes that Post-mastectomy radiation in high risk, node negative early breast cancer patients decreases rates of loco-regional recurrence and improves disease free survival and propose to address the question in randomized setting.
Interventions
RADIATIONPost Mastectomy Radiation therapy
Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks
Sponsors
Tata Memorial Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Arm Experimental Post Mastectomy Radiotherapy Arm No Intervention: No Post Mastectomy Radiotherapy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largest discrete tumour at least 2cm or if the tumour area comprises multiple small adjacent foci of invasive carcinoma then overall maximum dimension taken. This must be greater than 2cm. * Upfront total mastectomy (with minimum 1 mm margin clear of invasive cancer or DCIS) and axillary staging procedure (clearance, sampling or SNB) * T2 tumors with one risk factor or T1 tumors with any of the following two high risk factors such as presence of high grade, lymphovascular invasion, ER/PR negative, HER2 positivity, age \< 35 years. * Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy (if indicated) * Written, informed consent
Exclusion criteria
* Any pTis/3/4, M1 patients * Patients who have any pathologically involved axillary nodes (micro-metastasis may be allowed) * Patients who have undergone neoadjuvant systemic therapy. * Previous or concurrent malignancy other than non melanomatous skin cancer and carcinoma in situ of the cervix * Pregnancy * Bilateral breast cancer * Not fit for surgery, radiotherapy or adjuvant systemic therapy * Unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 5 years | This will be measured using Kaplan Meier time to event analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regional recurrence | 5 years | This is the incidence of recurrence in the regional lymphatics |
| Metastasis-free survival | 5 years | This will be measured using Kaplan Meier time to event analysis |
| Overall survival | 5 years | This will be measured using Kaplan Meier time to event analysis |
| Chest wall recurrence | 5 years | This is the incidence of local recurrence in the chest wall |
| Late Morbidity of radiotherapy | 6 months from end of radiotherapy to 5 years | RTOG Late radiation morbidity scoring |
| Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires | 5 years post surgery | Quality of life will be assesses by EORTC QLQ C-30 core questionnaire and the breast cancer specific module BR-23 questionnaire |
| Acute Morbidity of radiotherapy | 4 weeks from the start of radiotherapy | RTOG Acute radiation morbidity scoring |
Countries
India
Contacts
Primary ContactTabassum Wadasadawala, MBBS,MD,DNB
Outcome results
None listed