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TerminatedNCT06038539Updated Mar 13, 2026

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

A Phase 3 interventional study of PERT-IJS plus trastuzumab, carboplatin and docetaxel and Perjeta plus trastuzumab, carboplatin and docetaxel in HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients, sponsored by Biocon Biologics UK Ltd. Terminated at 1 site in India. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Biocon Biologics UK Ltd · Phase 3, Interventional, and Treatment

Why this study was terminated
US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study.
Phase
Phase 3
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
Female
01

Study summary

To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in neoadjuvant treatment of patients with HR-ve and HER-2 positive early stage or locally advanced breast cancer.

Read the detailed description

This study is designed to compare the efficacy and safety of proposed biosimilar PERT-IJS plus trastuzumab, carboplatin and docetaxel versus EU-Perjeta plus trastuzumab, carboplatin and docetaxel in neoadjuvant treatment of HR-ve HER2-positive Early Breast Cancer (EBC) (invasive breast cancer without distant metastasis) or locally advanced breast cancer patients.

02

Conditions studied

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

Keywords

  • Locally advanced breast cancer patient
  • HR negative HER2-positive Early breast cancer
  • PERT-IJS
  • Pertuzumab
  • Trastuzumab
  • Neoadjuvant treatment
03

In context

Lead sponsor

Biocon Biologics UK Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient willing and able to sign informed consent and to follow the protocol requirements
  2. Female patients aged ≥ 18 years at the time of Screening
  3. Patient with Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2

  4. Patients with breast cancer that meets the following criteria:

    1. A known case of histologically confirmed invasive breast carcinoma with a primary tumor size of > 2 cm by standard local assessment technique
    2. stage at presentation: early stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4a-c, any N, M0) or inflammatory (T4d, any N, M0)
  5. Patients with HER2 overexpression by Immunohistochemistry (IHC) (defined as IHC 3+, or IHC 2+ with Fluorescence In Situ Hybridization (FISH) confirmation) as per the American Society of Clinical Oncology/College of American Pathologist (ASCO-CAP) guidelines prior to Screening and confirmed centrally before randomization
  6. Patients with known HR-ve status (ER-negative and PR-negative) as per local laboratory prior to Screening and confirmed centrally before randomization
  7. Patient willing to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
  8. Patient who completes all necessary baseline laboratory and radiologic investigations prior to randomization as per Schedule of assessment (SoA)
  9. Patient with baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography (ECHO; preferred) or multiple-gated acquisition (MUGA) scan
  10. Patient is eligible to participant if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

Exclusion criteria

Exclusion Criteria:

  1. Patients with metastatic or recurrent bilateral breast cancer, or bilateral breast cancer
  2. Patients with a history of concurrent or previously treated non-breast malignancies. A patient with previous invasive non-breast cancer is eligible provided she has been disease free for more than 5 years
  3. Patients who have received any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, and antitumor vaccines) for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
  4. Concurrent anti-cancer treatment in another investigational study, including hormone therapy or immunotherapy
  5. Major surgical procedure that is unrelated to breast cancer within 4 weeks prior to randomization or from which the patient has not fully recovered

  6. Serious cardiac illness or medical condition including but not limited to the following as per Investigator's discretion:

    1. Patients with ≥ Class II stage of heart failure as per New York Heart Association Classification
    2. High risk uncontrolled arrhythmia, such as atrial tachycardia with a heart rate > 100 bpm at rest, significant ventricular arrhythmia (e.g., ventricular tachycardia) required treatment, or higher-grade atrioventricular (AV) block (i.e., Mobitz II second-degree AV block or third-degree AV block)
    3. History of myocardial infarction or unstable angina pectoris within 1 year of randomization or angina pectoris requiring anti-anginal medication
    4. Evidence of transmural infarction on ECG
    5. Clinically significant valvular heart disease
    6. Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) in patients on anti-hypertensive medications
  7. Other concurrent serious diseases that may interfere with study primary endpoint and other study assessments, including, but not limited to, severe pulmonary conditions/illness, active liver disease (for example, active viral hepatitis infection [i.e., hepatitis B or hepatitis C]), autoimmune disorders, history of or known patient of sclerosing cholangitis, or infection with Human immune deficiency virus (HIV)
  8. Patients with a history of any contraindication to the study treatment regimens

  9. Any of the following abnormal laboratory test results prior to randomization:

    1. Total bilirubin > upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin > 2 × ULN
    2. Aspartate aminotransferase and/or alanine aminotransferase > 1.5 × ULN, if considered clinically significant by Investigator
    3. Alkaline phosphatase >2.5 × ULN, if considered clinically significant by Investigator
    4. Serum creatinine > 1.5 × ULN
    5. Creatinine clearance \< 60 mL/min
    6. Total white blood cells count \< 2500 cells/μL
    7. Absolute neutrophil count \< 2000 cells/μL
    8. Platelet count \< 100,000 cells/μL
  10. Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within five half-lives (of the drug/ biologic) prior to the enrolment (whichever is longer)
  11. Have taken any live vaccines 30 days prior to the 1st dose of study treatment
  12. Any known hypersensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
  13. Patients unwilling to follow the study requirements.

  14. Presence of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the Investigator, may interfere with the interpretation of efficacy and safety parameters or has a medical condition for which the treatment should take precedence over study participation or will interfere with study participation

    -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Treatment Arm A: PERT-IJS plus trastuzumab, carboplatin and docetaxel

    Part 1 (Cycle 1 to 6): Initial loading dose of PERT-IJS is 840 mg administered as an approximately 60-minute IV infusion followed every 3 weeks by a maintenance dose of 420 mg administered as an IV infusion over a period of approximately 30 to 60 minutes. Trastuzumab: Initial dose of trastuzumab is 8 mg/kg administered as approximately 90-minute IV infusion followed every 3 weeks by 6 mg/kg IV infusion over 30 to 90 minutes Carboplatin: Area Under the Curve (AUC) 6 for Cycles 1 to 6 Docetaxel: 75 mg/m2 by IV infusion every 3 weeks for Cycles 1 to 6 Part 2 (Cycle 7 - till end of 1 year from Cycle 1 day 1): Initial loading dose of PERT-IJS is 840 mg administered as approximately 60-minute IV infusion followed every 3 weeks by a maintenance dose of 420 mg administered as an IV infusion over a period of approximately 30 to 60 minutes. Trastuzumab: As mentioned in part 1

    Biological: PERT-IJS plus trastuzumab, carboplatin and docetaxel

  • Active comparator
    Treatment Arm B: EU-Perjeta plus trastuzumab, carboplatin and docetaxel

    Part 1 (Cycle 1 to 6): Initial loading dose of EU- Perjeta is 840 mg administered as approximately 60-minute IV infusion followed every 3 weeks by a maintenance dose of 420 mg administered as an IV infusion over a period of approximately 30 to 60 minutes. Trastuzumab: Initial dose of trastuzumab is 8 mg/kg administered as approximately 90-minute IV infusion followed every 3 weeks by 6 mg/kg IV infusion over 30 to 90 minutes Carboplatin: Area under the curve 6 for Cycles 1 to 6 Docetaxel: 75 mg/m2 by IV infusion every 3 weeks for Cycles 1 to 6 Part 2 (Cycle 7 onwards till end of 01 year from Cycle 1 day 1): The patients will be re-randomized (1:1) to receive EU- Perjeta + trastuzumab or PERT-IJS + trastuzumab. Initial loading dose of PERT-IJS is 840 mg administered as approximately 60-minute IV infusion followed every 3 weeks by a maintenance dose of 420 mg administered as an IV infusion over a period of approximately 30 to 60 minutes. Trastuzumab: As mentioned in part 1

    Biological: Perjeta plus trastuzumab, carboplatin and docetaxel

Interventions

  • BiologicalPERT-IJS plus trastuzumab, carboplatin and docetaxel

    PERT-IJS is a monoclonal antibody, which has been developed by Biocon Biologics (earlier in collaboration with Viatris) as a proposed biosimilar to European Union (EU)-approved and United States (US) licensed Perjeta.

  • BiologicalPerjeta plus trastuzumab, carboplatin and docetaxel

    EU Perjeta (Pertuzumab) , an antineoplastic agent, is a recombinant humanized monoclonal antibody that specifically targets sub-domain 2 of the extracellular domain of Human Epidermal Growth Factor Receptor 2 (HER2), blocking heterodimerization of HER2 with other members of the receptor family, including epidermal growth factor, Human Epidermal Growth Factor Receptor 3 (HER3) and Human Epidermal Growth Factor Receptor 4 (HER4).

06

What researchers measure

Primary outcomes

  1. Efficacy endpoint - Total pathologic complete response between Treatment arm A and Treatment Arm B

    Total pathologic complete response (tpCR; ypT0/Tis,ypN0) in breast and axillary nodes after neoadjuvant treatment by Independent Review Committee (IRC)

    Time frame: Week 18

Secondary outcomes

  1. Efficacy endpoint-Total pathologic complete response between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen

    Total pathologic complete response (tpCR; ypT0/Tis, ypN0) in breast and axillary nodes after neoadjuvant treatment by local histopathologist

    Time frame: Week 18

  2. Efficacy endpoint: Pathologic complete response between Treatment Arm A and Treatment Arm B

    Pathologic complete response (pCR; ypT0/ypN0) after neoadjuvant treatment by IRC and local histopathologist

    Time frame: Week 18

  3. Efficacy endpoint- Breast pathologic complete response between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen

    Breast pathologic complete response (bpCR; ypT0/Tis) after neoadjuvant treatment by IRC and local histopathologist

    Time frame: Week 18

  4. Efficacy endpoint-Objective response rate between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen

    Objective response rate (ORR) after neoadjuvant treatment in accordance with Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

    Time frame: Week 18

  5. Efficacy endpoint-Event free survival rate between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen

    Event free survival (EFS) rate

    Time frame: Week 18

  6. Efficacy endpoint- Overall survival rate between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen

    Overall survival (OS) rate

    Time frame: Week 18

  7. Efficacy endpoint-EFS rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout

    EFS rate

    Time frame: 1 Year

  8. Efficacy endpoint - Overall Survival rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout

    Overall survival rate

    Time frame: 1 Year

  9. Efficacy endpoint - Overall Response Rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout

    Overall Response Rate

    Time frame: 1 Year

  10. Efficacy Endpoint: EFS rate after the single switch from EU-Perjeta to PERT-IJS+trastuzumab compared with those continuing on Treatment B

    EFS rate after switching of treatment from EU-Perjeta to PERT-IJS + trastuzumab

    Time frame: 1 year

  11. Efficacy Endpoint: Disease free survival rate after the single switch from from EU-Perjeta to PERT-IJS+trastuzumab compared with those continuing on EU-Perjeta+trastuzumab

    Disease free survival (DFS) rate after switching of treatment from EU-Perjeta to PERT-IJS + trastuzumab versus those continuing on EU-Perjeta + trastuzumab

    Time frame: 1 year

  12. Efficacy Endpoint: Overall survival rate after the single switch from from EU-Perjeta to PERT-IJS+trastuzumab compared with those continuing on EU-Perjeta+trastuzumab

    OS rate after switching of treatment from EU-Perjeta to PERT-IJS + trastuzumab versus those continuing on EU-Perjeta + trastuzumab

    Time frame: 1 year

  13. Pharmacokinetic (PK) endpoint-The trough serum concentration

    The trough serum concentration (Ctrough)

    Time frame: 1 Year

  14. Safety Endpoint: treatment-emergent adverse events and serious adverse events

    Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: week 18

  15. Safety Endpoint: left ventricular ejection fraction

    Incidence of patients with a decline in left ventricular ejection fraction (LVEF) of ≥ 10% from baseline to \< 50%

    Time frame: week 18

  16. Safety Endpoint: Vital signs

    Number of subjects with clinically significant changes in Vital signs

    Time frame: week 18

  17. Safety Endpoint-ECG PR Interval

    Number of subjects with clinically significant changes in ECG PR Interval

    Time frame: week 18

  18. Safety Endpoint-ECG QRS Interval

    Number of subjects with clinically significant changes in ECG QRS Interval

    Time frame: week 18

  19. Safety Endpoint-ECG QT Interval

    Number of subjects with clinically significant changes in ECG QT Interval

    Time frame: week 18

  20. Safety Endpoint- ECG corrected QT interval (QTc) Interval

    Number of subjects with clinically significant changes in ECG QTc Interval

    Time frame: week 18

  21. Safety Endpoint-clinical laboratory assessments

    Number of subjects with clinically significant changes in Clinical laboratory assessments

    Time frame: week 18

  22. Safety Endpoint-pregnancy test

    Number of subjects with Pregnancy outcome

    Time frame: week 18

  23. Safety Endpoint-physical examination

    Number of subjects with clinically significant changes in Physical examination

    Time frame: week 18

  24. Immunogenicity Endpoint

    Immunogenicity (anti-drug antibodies (ADA) and neutralizing antibodies (nAb) titers)

    Time frame: week 18

  25. Safety Endpoint: treatment-emergent adverse events and serious adverse events of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta

    Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: 1 year

  26. Safety Endpoint: left ventricular ejection fraction of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout

    Incidence of patients with a decline in left ventricular ejection fraction (LVEF) of ≥ 10% from baseline to \< 50%

    Time frame: 1 year

  27. Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS -throughout compared to patients randomized to EU-Perjeta throughout- Vital signs

    Number of subjects with clinically significant changes in Vital signs

    Time frame: 1 year

  28. Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout- ECG PR Interval

    Number of subjects with clinically significant changes in ECG PR Interval

    Time frame: 1 year

  29. Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout-ECG QRS Interval

    Number of subjects with clinically significant changes in ECG QRS Interval

    Time frame: 1 year

  30. Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout-ECG QT Interval

    Number of subjects with clinically significant changes in ECG QT Interval

    Time frame: 1 year

  31. Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout- ECG QTc Interval

    Number of subjects with clinically significant changes in ECG QTc Interval

    Time frame: 1 year

  32. Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout-Clinical laboratory assessments

    Number of subjects with clinically significant changes in Clinical laboratory assessments

    Time frame: 1 year

  33. Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout- Pregnancy test

    Number of subjects with Pregnancy outcome

    Time frame: 1 year

  34. Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout-Physical examination

    Number of subjects with clinically significant changes in Physical examination

    Time frame: 1 year

  35. Immunogenicity Endpoint of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout

    Immunogenicity (anti-drug antibodies (ADA) and neutralizing antibodies (nAb) titers)

    Time frame: 1 year

  36. Safety Endpoint: Incidence of TEAEs and SAEs after the single switch from EU-Perjeta to PERT-IJS+trastuzumab versus those continuing on EU-Perjeta+trastuzumab throughout

    Incidence of TEAEs and SAEs after switching of treatment from EU-Perjeta to PERT-IJS + trastuzumab versus those continuing on EU-Perjeta + trastuzumab

    Time frame: 1 Year

  37. Safety End Point :left ventricular ejection fraction incidences after the single switch from EU-Perjeta to PERT-IJS+trastuzumab versus those continuing on EU-Perjeta+trastuzumab

    Incidence of patients with a decline in left ventricular ejection fraction (LVEF) of ≥ 10% from baseline to \< 50%

    Time frame: 1 year

  38. Immunogenicity End Point: after the single switch from EU-Perjeta to PERT-IJS+trastuzumab versus those continuing on EU-Perjeta+trastuzumab

    Immunogenicity (ADA titer and nAb titer) after switching of treatment from EU-Perjeta to PERT-IJS plus trastuzumab versus those continuing on EU-Perjeta + trastuzumab

    Time frame: 1 Year

07

Study locations

1 site
  • Chopda Medicare & Research Centre Pvt. Ltd,
    Nashik, 422005, India
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06038539
Lead sponsor
Biocon Biologics UK Ltd
Responsible party
Sponsor
First posted
Sep 15, 2023
Start date
Jan 6, 2025
Primary completion
Dec 23, 2025
Completion
Dec 23, 2025
Last update
Mar 13, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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