Post-Mastectomy Radiation Therapy in High Risk, Node Negative Women With Early Breast Cancer (PMRT-NNBC)

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Post Mastectomy Radiation Therapy
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Post Graduate Institute of Medical Education & Research
RECRUITING
Chandigarh
Max Super Speciality Hospital, Shalimar Bagh
NOT_YET_RECRUITING
Delhi
Bhagwan Mahaveer Cancer Hospital and Research Centre
NOT_YET_RECRUITING
Jaipur
Kolhapur Cancer Centre Pvt Ltd
NOT_YET_RECRUITING
Kolhāpur
Tata Memorial Centre
RECRUITING
Mumbai
All India Institute of Medical Sciences
NOT_YET_RECRUITING
New Delhi
Max Super Speciality Hospital(A unit of Devki Devi Foundation)
NOT_YET_RECRUITING
New Delhi
Contact Information
Primary
Tabassum Wadasadawala, MBBS,MD,DNB
twadasadawala@actrec.gov.in
02227405078
Time Frame
Start Date: 2016-05-27
Estimated Completion Date: 2033-12
Participants
Target number of participants: 1022
Treatments
Experimental: Post Mastectomy Radiation Therapy (PMRT)
Post mastectomy radiotherapy will be given
No_intervention: Observation (No PMRT)
No adjuvant radiotherapy will be given.
Related Therapeutic Areas
Sponsors
Leads: Tata Memorial Centre

This content was sourced from clinicaltrials.gov