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

NCT02992574 | Recruiting DMC

• 2 other identifiers: 1602CTRI/2016/12/007532
• Study Type: interventional
• Target: 1,022
• Locations: 1 country
• Sites: 7

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.

Conditions

Breastcancer

Keywords

Post-Mastectomy Radiation; Node Negative; Early breast Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  This will be measured using Kaplan Meier time to event analysis

  5 years

Secondary Outcomes (7)

• Chest wall recurrence

  5 years

• Regional recurrence

  5 years

• Metastasis-free survival

  5 years

• Overall survival

  5 years

• Acute Morbidity of radiotherapy

  4 weeks from the start of radiotherapy

Study Arms (2)

Post Mastectomy Radiation Therapy (PMRT)

EXPERIMENTAL

Post mastectomy radiotherapy will be given

Radiation: Post Mastectomy Radiation therapy

Observation (No PMRT)

NO INTERVENTION

No adjuvant radiotherapy will be given.

Interventions

Post Mastectomy Radiation therapy RADIATION

Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks

Also known as: PMRT

Post Mastectomy Radiation Therapy (PMRT)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (7)

Post Graduate Institute of Medical Education & Research

Chandigarh, Chandigarh, 160012, India

RECRUITING

Kolhapur Cancer Centre Pvt Ltd

Kolhāpur, Maharashtra, 416234, India

NOT YET RECRUITING

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

Max Super Speciality Hospital, Shalimar Bagh

Delhi, National Capital Territory of Delhi, 110088, India

NOT YET RECRUITING

Max Super Speciality Hospital(A unit of Devki Devi Foundation)

New Delhi, National Capital Territory of Delhi, 110017, India

NOT YET RECRUITING

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

NOT YET RECRUITING

Bhagwan Mahaveer Cancer Hospital and Research Centre

Jaipur, Rajasthan, 302017, India

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tabassum Wadasadawala, MBBS,MD,DNB

  Assistant Professor, Radiation Oncology, Tata Memorial Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tabassum Wadasadawala, MBBS,MD,DNB

CONTACT

02227405078; twadasadawala@actrec.gov.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Radiation Oncology

Model Details: Arm Experimental Post Mastectomy Radiotherapy Arm No Intervention: No Post Mastectomy Radiotherapy

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: December 14, 2016
• Study Start: May 27, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2033
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (7)