Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer

Breastcancer Clinical Trial

— PMRT-NNBC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992574
• Other study ID #: 1602
• Secondary ID: CTRI/2016/12/007
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2016
• Est. completion date: December 2033

Study information

• Verified date: July 2022
• Source: Tata Memorial Centre
• Contact: Tabassum Wadasadawala, MBBS,MD,DNB
• Phone: 02227405078
• Email: twadasadawala[@]actrec.gov.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1022
• Est. completion date: December 2033
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Breastcancer

Intervention

Radiation:
• Post 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

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education & Research	Chandigarh
India	Max Super Speciality Hospital, Shalimar Bagh	Delhi
India	Bhagwan Mahaveer Cancer Hospital and Research Centre	Jaipur	Rajasthan
India	Kolhapur Cancer Centre Pvt Ltd	Kolhapur	Maharashtra
India	Tata Memorial Centre	Mumbai	Maharashtra
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Max Super Speciality Hospital(A unit of Devki Devi Foundation)	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	This will be measured using Kaplan Meier time to event analysis	5 years
Secondary	Chest wall recurrence	This is the incidence of local recurrence in the chest wall	5 years
Secondary	Regional recurrence	This is the incidence of recurrence in the regional lymphatics	5 years
Secondary	Metastasis-free survival	This will be measured using Kaplan Meier time to event analysis	5 years
Secondary	Overall survival	This will be measured using Kaplan Meier time to event analysis	5 years
Secondary	Acute Morbidity of radiotherapy	RTOG Acute radiation morbidity scoring	4 weeks from the start of radiotherapy
Secondary	Late Morbidity of radiotherapy	RTOG Late radiation morbidity scoring	6 months from end of radiotherapy to 5 years
Secondary	Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires	Quality of life will be assesses by EORTC QLQ C-30 core questionnaire and the breast cancer specific module BR-23 questionnaire	5 years post surgery