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

A PHASE IV, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB (PHESGO) IN INDIAN PATIENTS WITH HER2-POSITIVE BREAST CANCER

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/050070

Enrollment

108

Registered

2023-02-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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: Phesgo: Phesgo SC is administered at a dose of 15 ml (loading dose) or 10 ml (maintenance dose) on Day 1 of each 3-week treatment cycle Control Intervention1: Pertuzumab: Pertuzumab IV

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Incidence and severity of adverse events (AEs), with severity determined according to the NCI CTCAE v5.0 grading scale. a. Phesgo in combination with chemotherapy b. Phesgo without concurrent chemotherapy 2. Incidence and severity of serious adverse events (SAEs), with severity determined according to the NCI CTCAE v5.0 grading scale 3. Incidence and severity of adverse events of special interest (AESIs)Timepoint: 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.	—

Measure

Time frame

1. Incidence and severity of adverse events (AEs), with severity determined according to the NCI CTCAE v5.0 grading scale. a. Phesgo in combination with chemotherapy b. Phesgo without concurrent chemotherapy 2. Incidence and severity of serious adverse events (SAEs), with severity determined according to the NCI CTCAE v5.0 grading scale 3. Incidence and severity of adverse events of special interest (AESIs)Timepoint: 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

Measure	Time frame
1 For Cohort 1 only: to evaluate total pathological complete response (tpCR) 2 For Cohort 3 only: to evaluate Overall Response Rate (ORR) 3 To assess healthcare professionals (HCP) perception on time/resource for using SC versus IV formulationTimepoint: At baseline and at end of the treatment period.	—

Countries

India

Contacts

Public ContactHeta Khokhani

Roche Products (India) Pvt. Ltd.

viraj.suvarna@roche.com9820006317

Outcome results

None listed

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