# Comparing efficacy and safety of P013, a proposed pertuzumab biosimilar, with the reference product in HER2-positive breast cancer patients: a randomized, phase III, equivalency clinical trial

Source: https://onco.cc/key-papers/paper-p013-pertuzumab-biosimilar-bmc-cancer-2022/  
OnCo record `paper-p013-pertuzumab-biosimilar-bmc-cancer-2022` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial in Iran found that a locally made copy of pertuzumab, given before surgery, cleared tumours from the breast as often as the original.

## Summary

214 chemotherapy-naive women with HER2-positive breast cancer were randomised 1:1 to six cycles of P013 (CinnaGen) or Perjeta (Roche) with trastuzumab, carboplatin and docetaxel every three weeks, stratified by cancer type and hormone receptor status. The primary endpoint was breast pathological complete response. A correction was published in BMC Cancer in 2022 (DOI 10.1186/s12885-022-10455-0).

## Fields

- Kind: Key paper
- Last checked: 2026-11-04
- Journal: BMC Cancer
- Year: 2022
- DOI: 10.1186/s12885-022-09895-5
- Authors: Allahyari A, Ehsanpour A, Najafi B, et al.
- Findings: Breast pathological complete response was 67.62% with P013 and 71.57% with the reference product in the per-protocol population.; Mean difference -0.04 (95% CI -0.16 to 0.09), meeting the equivalence criterion.; Total pathological complete response, overall response, breast-conserving surgery, safety and immunogenicity were comparable.
- What it means: A pertuzumab made in Iran has now been tested against the original, beside the locally made trastuzumab it is given with. A 2025 analysis of Iran's breast cancer services nevertheless listed pertuzumab among four medicines not covered by health insurance.
- Caveats: Industry-sponsored; registered on ClinicalTrials.gov after it was completed, though registered in the Iranian registry before it began.; Pathological complete response is a surrogate; no survival data are reported.

## Sources

- BMC Cancer 2022: https://doi.org/10.1186/s12885-022-09895-5
- PubMed: https://pubmed.ncbi.nlm.nih.gov/36071409/
- Correction, BMC Cancer 2022: https://doi.org/10.1186/s12885-022-10455-0

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Pertuzumab](https://onco.cc/drugs/pertuzumab/), [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- companies: [CinnaGen](https://onco.cc/companies/cinnagen/)
- terms: [Biosimilar](https://onco.cc/terms/biosimilar/)
- trials: [P013 (CinnaGen pertuzumab) against Perjeta before surgery for HER2-positive breast cancer](https://onco.cc/trials/nct04957212/)

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