# A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

> **NCT03013504** · PHASE3 · COMPLETED · sponsor: **Prestige Biopharma Limited** · enrollment: 503 (actual)

## Conditions studied

- HER2 Positive Breast Cancer

## Interventions

- **DRUG:** HD201
- **DRUG:** Herceptin
- **DRUG:** Docetaxel
- **DRUG:** Epirubicin
- **DRUG:** Cyclophosphamide

## Key facts

- **NCT ID:** NCT03013504
- **Lead sponsor:** Prestige Biopharma Limited
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2018-02-19
- **Primary completion:** 2019-04-19
- **Final completion:** 2022-01-13
- **Target enrollment:** 503 (ACTUAL)
- **Last updated:** 2024-11-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03013504

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03013504, "A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03013504. Licensed CC0.

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