BreastcancerPMRT-NNBCNCT02992574
Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer
A study testing Post Mastectomy Radiation therapy in people with Breastcancer, run by Tata Memorial Centre at 7 sites in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breastcancer
- What is being tested?
- Post Mastectomy Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,022 participants
- Where
- 7 sitesIndia
- Study dates
- 27 May 2016to Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
India7 sites, 7 recruiting
- Recruiting
Post Graduate Institute of Medical Education & Research
Chandigarh, Chandigarh, 160012
Budhi S Yadav, MBBS,MD, 9815981176, drbudhi@gmail.com
Budhi S Yadav, MBBS,MD
- Not yet recruiting
Max Super Speciality Hospital, Shalimar Bagh
Delhi, National Capital Territory of Delhi, 110088
Vineeta Goel, MBBS, DNB, 9818045469, vineetagoel@yahoo.com
Vineeta Goel, MBBS,DNB
- Not yet recruiting
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, Rajasthan, 302017
Nidhi Patni, MBBS,MD, 9828052239, nidhionco@gmail.com
Nidhi Patni, MBBS, MD
- Not yet recruiting
Kolhapur Cancer Centre Pvt Ltd
Kolhāpur, Maharashtra, 416234
Yogesh Anap, MBBS,MD,DNB, 9420635556, yogesh.anap1@gmail.com
Yogesh Anap, MBBS,MD,DNB
- Recruiting
Tata Memorial Centre
Mumbai, Maharashtra, 400012
Tabassum Wadasadawala, MBBS,MD,DNB, 02227405078, twadasadawala@actrec.gov.in
Tabassum Wadasadawala, MBBS,MD,DNB
- Not yet recruiting
Max Super Speciality Hospital(A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, 110017
Anil K Anand, MBBS,MD, 9810398838, akanand@maxhealthcare.com
Anil K Anand, MBBS,MD
- Not yet recruiting
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Ritesh Kumar, MBBS, MD, 9953774134, riteshkr9@gmail.com
Ritesh Kumar, MBBS, MD
About this study
Official title: Post-Mastectomy Radiation Therapy in High Risk, Node Negative Women With Early Breast Cancer (PMRT-NNBC)
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
- Being tested
- Post Mastectomy Radiation therapy
- Keywords
- Post-Mastectomy Radiation, Node Negative, Early breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Mastectomy Radiation therapyRadiation
Also called PMRT
Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Post Mastectomy Radiation Therapy (PMRT) | Experimental | Post mastectomy radiotherapy will be given Receives: Radiation: Post Mastectomy Radiation therapy |
| Observation (No PMRT) | No intervention | No adjuvant radiotherapy will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
This will be measured using Kaplan Meier time to event analysis
Measured: 5 years
Secondary outcomes (7)
Chest wall recurrence
This is the incidence of local recurrence in the chest wall
Measured: 5 years
Regional recurrence
This is the incidence of recurrence in the regional lymphatics
Measured: 5 years
Metastasis-free survival
This will be measured using Kaplan Meier time to event analysis
Measured: 5 years
Overall survival
This will be measured using Kaplan Meier time to event analysis
Measured: 5 years
Acute Morbidity of radiotherapy
RTOG Acute radiation morbidity scoring
Measured: 4 weeks from the start of radiotherapy
Late Morbidity of radiotherapy
RTOG Late radiation morbidity scoring
Measured: 6 months from end of radiotherapy to 5 years
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
Measured: 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start27 May 2016
- Primary completionDec 2028 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm Experimental Post Mastectomy Radiotherapy Arm No Intervention: No Post Mastectomy Radiotherapy
- Masking
- None (open label)
- Enrolment
- 1,022 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tabassum Wadasadawala, Tata Memorial Centre
- Investigators
- Tabassum Wadasadawala, MBBS,MD,DNB, Principal investigator, Assistant Professor, Radiation Oncology, Tata Memorial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992574
- Sponsor's protocol ID
- 1602
- Other IDs
- CTRI/2016/12/007532
- Acronym
- PMRT-NNBC
- Status last verified
- Apr 2025
- First submitted
- 11 Dec 2016
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Mastectomy Radiation Therapy in High Risk, Node Negative Women With Early Breast Cancer (PMRT-NNBC)
- ClinicalTrials.gov ID
- NCT02992574
- Acronym / sponsor ID
- PMRT-NNBC / 1602
- Conditions
- Breastcancer
- Keywords
- Post-Mastectomy Radiation, Node Negative, Early breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,022 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 27 May 2016 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm Experimental Post Mastectomy Radiotherapy Arm No Intervention: No Post Mastectomy Radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Post Mastectomy Radiation Therapy (PMRT) | Experimental | Radiation: Post Mastectomy Radiation therapyPost mastectomy radiotherapy will be given |
| Observation (No PMRT) | No intervention | –No adjuvant radiotherapy will be given. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post Mastectomy Radiation therapyAlso: PMRTPost mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks | Radiation | Post Mastectomy Radiation Therapy (PMRT) |
Primary outcome
Disease free survival
Time frame: 5 years
This will be measured using Kaplan Meier time to event analysis
7 secondary outcomes
Chest wall recurrence
Time frame: 5 years
Regional recurrence
Time frame: 5 years
Metastasis-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Acute Morbidity of radiotherapy
Time frame: 4 weeks from the start of radiotherapy
Late Morbidity of radiotherapy
Time frame: 6 months from end of radiotherapy to 5 years
Quality of life scores under different domains of the QLQ C-30 and BR-23 questionnaires
Time frame: 5 years post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tabassum Wadasadawala, MBBS,MD,DNB principal investigator
Assistant Professor, Radiation Oncology, Tata Memorial Centre
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post Mastectomy Radiation therapy in people with Breastcancer, run by Tata Memorial Centre at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tabassum Wadasadawala, MBBS,MD,DNB (02227405078, twadasadawala@actrec.gov.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.