CTRI/2024/06/068847
Not yet recruiting
Phase 2
eoadjuvant Radiotherapy in breast Cancer, A study on the optimal sequencing of radiation in breast cancer. - NeoORB
All India Institute of Medical Sciences, Jodhpur0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- All India Institute of Medical Sciences, Jodhpur
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Eligibility for NACT:
- •Patients with inoperable breast cancer:
- •a)Bulky or matted cN2 axillary nodes
- •b)cN3 nodal disease
- •c)cT4 tumors(Inflammatory breast cancer if disease can be contained in radiotherapy portal)
- •In select patients with operable breast cancer:
- •a)HER2\-positive disease and TNBC, if \=cT2 or \=cN1
- •b)Large primary tumor relative to breast size in a patient who desires breast conservation.
- •c)cN\+ disease likely to become cN0 with preoperative systemic therapy.
- •d)cT1c, cN0, HER2\-positive disease and TNBC.
Exclusion Criteria
- •1\)Pregnancy or lactation
- •2\)Prior radiotherapy of the affected or contralateral breast
- •3\)Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans
- •4\)Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA II or AHA C, pacemaker, and/or implanted defibrillator
- •5\)Other medical conditions that prohibit the neoadjuvant chemotherapy (i.e. psychiatric diseases, non\-compliance, etc.)
- •6\)Patients with pure ductal carcinomas in situ.
- •7\)Patients with non\-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors
- •8\)Synchronous primary
Outcomes
Primary Outcomes
Not specified
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