A clinical trial to compare the effects of chemotherapy and trastuzumab combined with radiation therapy followed by surgery versus only chemotherapy and trastuzumab followed by surgery and then radiation therapy in Her 2 neu positive locally advanced breast cancers

Phase 2

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

• Registration Number: CTRI/2021/02/031588
• Lead Sponsor: Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.All female patients with Her2 positive LABC who are planned for CTRT with paclitaxel and trastuzumab as neoadjuvant modality of treatment after multi-speciality board discussion.

2.The following stages as per AJCC TNM staging 8th edition will be considered as LABC (IIIA, IIIB and IIIC). Except for patients with T4a tumors (chest wall fixity).

3.Age between 18 to 65 years

4.Karnofsky performance status score >=70

5.Normal cardiac function with echocardiography showing Ejection Fraction (EF) > 50%

Exclusion Criteria

1.Patients with metastatic disease

2.Patients with chest wall fixity of tumor, as they are not considered for surgery after completion of neoadjuvant treatment.

3.Inflammatory breast cancer.

4.Male breast cancer

5.Patients deemed inoperable at presentation due to factors like lymphedema, chest wall fixity or cutaneous nodules extending beyond the confines of the breast.

6.SGOT (AST) > 2.0 x upper limit of normal (ULN) and SGPT (ALT) >2.0 x ULN and Bilirubin >1.5 x ULN

7.Serum creatinine > ULN

8.Patient has received prior radiotherapy to the affected breast

9.Patients with uncontrolled diabetes mellitus, hypertension or ischemic heart disease.

10.Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.

11.Hypersensitivity to paclitaxel

12.Grade 2 or more peripheral neuropathy

13.Patient not consenting for treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified