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

Neoadjuvant Concurrent Chemo-radiation with Paclitaxel and Trastuzumab versus Neoadjuvant chemotherapy with trastuzumab followed by sequential radiation in locally advanced Her2 neu positive breast cancers: a phase 2 randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031588

Enrollment

126

Registered

2021-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Experimental Arm: Concurrent Chemoradiotherapy with taxol and trastuzumab in Her 2 neu positive locally advanced breast cancers Control Intervention1: Standard Arm: Neoadjuvant chemothe

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Pathological complete response ratesTimepoint: After Modified radical mastectomy	—

Secondary

Measure	Time frame
Safety and efficacyTimepoint: Till completion of surgery	—

Countries

India

Contacts

Public ContactPriya Iyer

Cancer Institute, Chennai, India

priyaonc@gmail.com9498082772

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026