# Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer

> **NCT06038539** · PHASE3 · TERMINATED · sponsor: **Biocon Biologics UK Ltd** · enrollment: 55 (actual)

## Conditions studied

- HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients

## Interventions

- **BIOLOGICAL:** PERT-IJS plus trastuzumab, carboplatin and docetaxel
- **BIOLOGICAL:** Perjeta plus trastuzumab, carboplatin and docetaxel

## Key facts

- **NCT ID:** NCT06038539
- **Lead sponsor:** Biocon Biologics UK Ltd
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2025-01-06
- **Primary completion:** 2025-12-23
- **Final completion:** 2025-12-23
- **Target enrollment:** 55 (ACTUAL)
- **Why stopped:** US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study.
- **Last updated:** 2026-03-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06038539

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06038539, "Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer". Retrieved via AI Analytics 2026-09-25 from https://api.ai-analytics.org/clinical/NCT06038539. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*