Comparison of radiotherapy given before or after surgery in patients with breast cancer receiving chemotherapy before surgery.

Not Applicable

• Conditions: Health Condition 1: C50- Malignant neoplasm of breast

• Registration Number: CTRI/2024/07/070327
• Lead Sponsor: Tata Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Age = 18 years

2. Patients must have a pathological proof of an invasive epithelial breast malignancy at

the treating institute. A core biopsy with adequate specimen quality is necessary for

this. FNAC alone is not sufficient. Biopsies taken outside must have been reviewed

for pathological confirmation and specimen adequacy at the treating institute.Patients

with ductal and lobular cancers are eligible for the study.

3. Receptor status (Oestrogen receptor, Progesterone receptor and HER2 neu receptor)

status should be documented. Patients can be enrolled with an equivocal HER2neu

receptor report but in all such cases a confirmatory in-situ hybridisation should be

done to confirm the status prior to initiation of taxane based chemotherapy.

4. ECOG performance status 0 - 2.

5. Clinical stage I - III disease as documented with adequate pretreatment staging.

Adequate staging include either of the two following options:

a. Whole body 18-FDG PET CT (preferred)

b. Contrast enhanced CT scan of the thorax and abdomen and a bone scan. Note

that chest X ray or USG abdomen are not acceptable substitutes.

6. Patients should have been planned for neoadjuvant chemotherapy as per institutional

protocol.

7. Patients with tumour that is likely to be amenable for curative intent resection of the

breast primary, following neoadjuvant therapy.

8. If the patient had nodal disease in the supraclavicular fossa (proven pathologically) or

internal mammary nodes (proven radiologically or pathologically), then residual gross

nodes should not be present in these regions post NACT.

Exclusion Criteria

1. Patients planned for therapeutic mammoplasty.

2. Patients planned for chest wall perforator flaps. This criteria will be re-evaluated after

the data from the perforator substudy is available and has been reviewed by the

DSMC.

3. Patients with non-epithelial malignant conditions of breast viz. Sarcomas, lymphomas

and phyllodes breast tumours.

4. Patients with skin cancer affecting the breast.

5. Prior radiotherapy to the ipsilateral breast or chest wall or mediastinum.

6. Concurrent illness, including severe infection that may jeopardise the ability of the

patient to undergo the procedures outlined in this protocol with reasonable safety

7. Serious medical or psychiatric conditions that might limit the ability of the patient to

comply with the protocol.

Patients enrolled for trials of investigational drugs should not be enrolled for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified