Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer
NCT ID: NCT02992574
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
1022 participants
INTERVENTIONAL
2016-05-27
2033-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Necessity of Post-mastectomy Radiotherapy After Neoadjuvant Chemotherapy and Mastectomy
NCT05993559
Local and Regional Radiotherapy for Nipple Sparing Mastectomy With Implant
NCT05213962
Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients
NCT04320979
Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers
NCT02883985
The Postoperative Radiotherapy in N1 Breast Cancer Patients
NCT05440149
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Post Mastectomy Radiation Therapy (PMRT)
Post mastectomy radiotherapy will be given
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
Observation (No PMRT)
No adjuvant radiotherapy will be given.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tata Memorial Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Tabassum Wadasadawala
Associate Professor, Radiation Oncology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tabassum Wadasadawala, MBBS,MD,DNB
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor, Radiation Oncology, Tata Memorial Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Post Graduate Institute of Medical Education & Research
Chandigarh, Chandigarh, India
Kolhapur Cancer Centre Pvt Ltd
Kolhāpur, Maharashtra, India
Tata Memorial Centre
Mumbai, Maharashtra, India
Max Super Speciality Hospital, Shalimar Bagh
Delhi, National Capital Territory of Delhi, India
Max Super Speciality Hospital(A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Bhagwan Mahaveer Cancer Hospital and Research Centre
Jaipur, Rajasthan, India
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CTRI/2016/12/007532
Identifier Type: REGISTRY
Identifier Source: secondary_id
1602
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.