To Evaluate The Safety and Efficacy of Pertuzumab and Trastuzumab (Phesgo)in Breast Cancer Patients

Phase 4

Recruiting

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2023/02/050070
• Lead Sponsor: Roche Products India Pvt Ltd

Brief Summary

This is a Phase IV, open-label, randomized, crossover,multicenter study designed to evaluate the safety and efficacy of Phesgo inadult patients who have been diagnosed with HER2+ eBC or mBC in India.

All patients fulfilling the eligibility criteria andwilling to provide informed consent will be enrolled in the study.  The estimated duration of patient enrollmentis approximately 20 months.  The patientenrollment will be stratified into three cohorts according to the breast cancerstage and treatment setting.  Cohort 1will include patients diagnosed with HER2+ eBC and planning to take neoadjuvantchemotherapy before surgery; Cohort 2 will include patients withnon-metastatic, adequately excised, histologically confirmed invasive HER2+ eBCand planning to take adjuvant therapy; and Cohort 3 will include patientsdiagnosed with HER2+ mBC who have not received prior anti-cancer therapy formBC.  Patients will be enrolled into thethree cohorts in the ratio of 2:1:2 i.e., Cohort 1 (approximately 40% of totalenrolled population), Cohort 2 (approximately 20% of total enrolled population),and Cohort 3 (approximately 40% of total enrolled population).  Patients enrolled in Cohort 1 and completingthe neoadjuvant therapy would not be enrolled in Cohort 2.

Patient’s participation in the study will include threeperiods: screening period, treatment period, and post-treatment period.  Eligibility of the patients will be assessedwithin a 28‑days screening period.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

Signed Informed Consent Form Women of age ≥18 years at time of signing Informed Consent Form HER2+ breast cancer status confirmed by local laboratory before study enrollment Hormone receptor status of the primary tumor determined by local assessment.

Exclusion Criteria

Treatment with investigational therapy within 4 weeks of enrollment Serious cardiac illness or medical conditions History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias Inadequate bone marrow function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence and severity of adverse events (AEs), with severity determined according to the NCI CTCAE v5.0 grading scale.	The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
2. Incidence and severity of serious adverse events (SAEs), with severity determined according to the NCI CTCAE v5.0 grading scale	The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
a. Phesgo in combination with chemotherapy	The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
b. Phesgo without concurrent chemotherapy	The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.
3. Incidence and severity of adverse events of special interest (AESIs)	The primary analysis will be performed on safety analysis set that will include all enrolled patients who receive at least one dose of Phesgo or P plus H IV.

Secondary Outcome Measures

Name	Time	Method
1 For Cohort 1 only: to evaluate total pathological complete response (tpCR)	2 For Cohort 3 only: to evaluate Overall Response Rate (ORR)

Trial Locations

Locations (13)

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Delhi, DELHI, India

Basavatarakam Indo American Cancer Hospital & Research Institute; 🇮🇳 Hyderabad, TELANGANA, India

Day Care Angels; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. B L Kapur Memorial Hospital; 🇮🇳 Delhi, DELHI, India

HCG Cancer Centre; 🇮🇳 Jaipur, RAJASTHAN, India

HCG-Cancer Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Health Care Global Enterprises Ltd; 🇮🇳 Bangalore, KARNATAKA, India

Hemato Oncology Clinic Ahmedabad Pvt Ltd; 🇮🇳 Ahmadabad, GUJARAT, India

Manipal Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Max Super Speciality Hospital; 🇮🇳 Delhi, DELHI, India

Scroll for more (3 remaining)

All India Institute of Medical Sciences (AIIMS)

🇮🇳Delhi, DELHI, India

Dr Ajay Gogia

Principal investigator

9013000642

ajaygogia@gmail.com