A study on the optimal sequencing of radiation In breast cancer(NEOORB)

Phase 2

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2024/06/068847
• Lead Sponsor: All India Institute of Medical Sciences, Jodhpur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

2)Pathological evidence of breast cancer

3)Informed consent for NACT signed by the patient

4)Absence of Distant mets

5)Age =18 years at the time of randomisation

6)Performance status = 2

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified