HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer PatientsPhase 3NCT06038539
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 study testing PERT-IJS plus trastuzumab, carboplatin and docetaxel and Perjeta plus trastuzumab, carboplatin and docetaxel in people with HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients, run by Biocon Biologics UK Ltd at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
- What is being tested?
- PERT-IJS plus trastuzumab, carboplatin and docetaxel and Perjeta plus trastuzumab, carboplatin and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIndia
- Study dates
- 6 Jan 2025to 23 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient willing and able to sign informed consent and to follow the protocol requirements
- Female patients aged ≥ 18 years at the time of Screening
- Patient with Eastern Cooperative Oncology Group (ECOG) Performance Status < 2
- Patients with breast cancer that meets the following criteria:
- A known case of histologically confirmed invasive breast carcinoma with a primary tumor size of > 2 cm by standard local assessment technique
- 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)
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- 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
- Patients with known HR-ve status (ER-negative and PR-negative) as per local laboratory prior to Screening and confirmed centrally before randomization
- Patient willing to undergo mastectomy or breast-conserving surgery after neoadjuvant therapy
- Patient who completes all necessary baseline laboratory and radiologic investigations prior to randomization as per Schedule of assessment (SoA)
- Patient with baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography (ECHO; preferred) or multiple-gated acquisition (MUGA) scan
- Patient is eligible to participant if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Who cannot join
- Patients with metastatic or recurrent bilateral breast cancer, or bilateral breast cancer
- 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
- 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
- Concurrent anti-cancer treatment in another investigational study, including hormone therapy or immunotherapy
- Major surgical procedure that is unrelated to breast cancer within 4 weeks prior to randomization or from which the patient has not fully recovered
- Serious cardiac illness or medical condition including but not limited to the following as per Investigator's discretion:
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- Patients with ≥ Class II stage of heart failure as per New York Heart Association Classification
- 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)
- History of myocardial infarction or unstable angina pectoris within 1 year of randomization or angina pectoris requiring anti-anginal medication
- Evidence of transmural infarction on ECG
- Clinically significant valvular heart disease
- Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) in patients on anti-hypertensive medications
- 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)
- Patients with a history of any contraindication to the study treatment regimens
- Any of the following abnormal laboratory test results prior to randomization:
- Total bilirubin > upper limit of normal (ULN) or, for cases of known Gilbert's syndrome, total bilirubin > 2 × ULN
- Aspartate aminotransferase and/or alanine aminotransferase > 1.5 × ULN, if considered clinically significant by Investigator
- Alkaline phosphatase >2.5 × ULN, if considered clinically significant by Investigator
- Serum creatinine > 1.5 × ULN
- Creatinine clearance < 60 mL/min
- Total white blood cells count < 2500 cells/μL
- Absolute neutrophil count < 2000 cells/μL
- Platelet count < 100,000 cells/μL
- 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)
- Have taken any live vaccines 30 days prior to the 1st dose of study treatment
- Any known hypersensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol
- Patients unwilling to follow the study requirements.
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer
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.
- Being tested
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Keywords
- Locally advanced breast cancer patient, HR negative HER2-positive Early breast cancer, PERT-IJS, Pertuzumab, Trastuzumab, Neoadjuvant treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERT-IJS plus trastuzumab, carboplatin and docetaxelBiological
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.
Perjeta plus trastuzumab, carboplatin and docetaxelBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A: PERT-IJS plus trastuzumab, carboplatin and docetaxel | Experimental | 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 Receives: Biological: PERT-IJS plus trastuzumab, carboplatin and docetaxel |
| Treatment Arm B: EU-Perjeta plus trastuzumab, carboplatin and docetaxel | Active comparator | 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 Receives: Biological: Perjeta plus trastuzumab, carboplatin and docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 18
Secondary outcomes (38)
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
Measured: Week 18
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
Measured: Week 18
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
Measured: Week 18
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)
Measured: Week 18
Efficacy endpoint-Event free survival rate between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen
Event free survival (EFS) rate
Measured: Week 18
Efficacy endpoint- Overall survival rate between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen
Overall survival (OS) rate
Measured: Week 18
Efficacy endpoint-EFS rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout
EFS rate
Measured: 1 Year
Efficacy endpoint - Overall Survival rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout
Overall survival rate
Measured: 1 Year
Efficacy endpoint - Overall Response Rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout
Overall Response Rate
Measured: 1 Year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Pharmacokinetic (PK) endpoint-The trough serum concentration
The trough serum concentration (Ctrough)
Measured: 1 Year
Safety Endpoint: treatment-emergent adverse events and serious adverse events
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: week 18
Safety Endpoint: left ventricular ejection fraction
Incidence of patients with a decline in left ventricular ejection fraction (LVEF) of ≥ 10% from baseline to < 50%
Measured: week 18
Safety Endpoint: Vital signs
Number of subjects with clinically significant changes in Vital signs
Measured: week 18
Safety Endpoint-ECG PR Interval
Number of subjects with clinically significant changes in ECG PR Interval
Measured: week 18
Safety Endpoint-ECG QRS Interval
Number of subjects with clinically significant changes in ECG QRS Interval
Measured: week 18
Safety Endpoint-ECG QT Interval
Number of subjects with clinically significant changes in ECG QT Interval
Measured: week 18
Safety Endpoint- ECG corrected QT interval (QTc) Interval
Number of subjects with clinically significant changes in ECG QTc Interval
Measured: week 18
Safety Endpoint-clinical laboratory assessments
Number of subjects with clinically significant changes in Clinical laboratory assessments
Measured: week 18
Safety Endpoint-pregnancy test
Number of subjects with Pregnancy outcome
Measured: week 18
Safety Endpoint-physical examination
Number of subjects with clinically significant changes in Physical examination
Measured: week 18
Immunogenicity Endpoint
Immunogenicity (anti-drug antibodies (ADA) and neutralizing antibodies (nAb) titers)
Measured: week 18
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)
Measured: 1 year
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%
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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)
Measured: 1 year
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
Measured: 1 Year
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%
Measured: 1 year
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
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start6 Jan 2025
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Why it stopped: US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Biologics UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038539
- Sponsor's protocol ID
- BIO-PERTUZ-301
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Compare the Efficacy and Safety of the Proposed Biosimilar PERT-IJS and EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Patients With Hormone Receptor Negative (HR-ve) Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Stage or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06038539
- Acronym / sponsor ID
- BIO-PERTUZ-301
- Keywords
- Locally advanced breast cancer patient, HR negative HER2-positive Early breast cancer, PERT-IJS, Pertuzumab, Trastuzumab, Neoadjuvant treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Biocon Biologics UK LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A: PERT-IJS plus trastuzumab, carboplatin and docetaxel | Experimental | Biological: PERT-IJS plus trastuzumab, carboplatin and docetaxelPart 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 |
| Treatment Arm B: EU-Perjeta plus trastuzumab, carboplatin and docetaxel | Active comparator | Biological: Perjeta plus trastuzumab, carboplatin and docetaxelPart 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient willing and able to sign informed consent and to follow the protocol requirements
- Female patients aged ≥ 18 years at the time of Screening
- Patient with Eastern Cooperative Oncology Group (ECOG) Performance Status < 2
- Patients with breast cancer that meets the following criteria:
- 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
Key exclusion criteria (29 listed)
- Patients with metastatic or recurrent bilateral breast cancer, or bilateral breast cancer
- 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
- 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
- Concurrent anti-cancer treatment in another investigational study, including hormone therapy or immunotherapy
- Major surgical procedure that is unrelated to breast cancer within 4 weeks prior to randomization or from which the patient has not fully recovered
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERT-IJS plus trastuzumab, carboplatin and docetaxelPERT-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. | Biological | Treatment Arm A: PERT-IJS plus trastuzumab, carboplatin and docetaxel |
| Perjeta plus trastuzumab, carboplatin and docetaxelEU 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). | Biological | Treatment Arm B: EU-Perjeta plus trastuzumab, carboplatin and docetaxel |
Primary outcome
Efficacy endpoint - Total pathologic complete response between Treatment arm A and Treatment Arm B
Time frame: Week 18
Total pathologic complete response (tpCR; ypT0/Tis,ypN0) in breast and axillary nodes after neoadjuvant treatment by Independent Review Committee (IRC)
38 secondary outcomes
Efficacy endpoint-Total pathologic complete response between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen
Time frame: Week 18
Efficacy endpoint: Pathologic complete response between Treatment Arm A and Treatment Arm B
Time frame: Week 18
Efficacy endpoint- Breast pathologic complete response between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen
Time frame: Week 18
Efficacy endpoint-Objective response rate between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen
Time frame: Week 18
Efficacy endpoint-Event free survival rate between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen
Time frame: Week 18
Efficacy endpoint- Overall survival rate between Treatment Arm A and Treatment Arm B as neoadjuvant treatment regimen
Time frame: Week 18
Efficacy endpoint-EFS rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout
Time frame: 1 Year
Efficacy endpoint - Overall Survival rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout
Time frame: 1 Year
Efficacy endpoint - Overall Response Rate of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout
Time frame: 1 Year
Efficacy Endpoint: EFS rate after the single switch from EU-Perjeta to PERT-IJS+trastuzumab compared with those continuing on Treatment B
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
Pharmacokinetic (PK) endpoint-The trough serum concentration
Time frame: 1 Year
Safety Endpoint: treatment-emergent adverse events and serious adverse events
Time frame: week 18
Safety Endpoint: left ventricular ejection fraction
Time frame: week 18
Safety Endpoint: Vital signs
Time frame: week 18
Safety Endpoint-ECG PR Interval
Time frame: week 18
Safety Endpoint-ECG QRS Interval
Time frame: week 18
Safety Endpoint-ECG QT Interval
Time frame: week 18
Safety Endpoint- ECG corrected QT interval (QTc) Interval
Time frame: week 18
Safety Endpoint-clinical laboratory assessments
Time frame: week 18
Safety Endpoint-pregnancy test
Time frame: week 18
Safety Endpoint-physical examination
Time frame: week 18
Immunogenicity Endpoint
Time frame: week 18
Safety Endpoint: treatment-emergent adverse events and serious adverse events of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta
Time frame: 1 year
Safety Endpoint: left ventricular ejection fraction of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout
Time frame: 1 year
Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS -throughout compared to patients randomized to EU-Perjeta throughout- Vital signs
Time frame: 1 year
Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout- ECG PR Interval
Time frame: 1 year
Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout-ECG QRS Interval
Time frame: 1 year
Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout-ECG QT Interval
Time frame: 1 year
Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout- ECG QTc Interval
Time frame: 1 year
Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout-Clinical laboratory assessments
Time frame: 1 year
Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout- Pregnancy test
Time frame: 1 year
Safety Endpoint: Routine safety parameters of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout-Physical examination
Time frame: 1 year
Immunogenicity Endpoint of patients randomized to PERT-IJS throughout compared to patients randomized to EU-Perjeta throughout
Time frame: 1 year
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
Time frame: 1 Year
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
Time frame: 1 year
Immunogenicity End Point: after the single switch from EU-Perjeta to PERT-IJS+trastuzumab versus those continuing on EU-Perjeta+trastuzumab
Time frame: 1 Year
Results and safety
The study was stopped early (reason given: US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PERT-IJS plus trastuzumab, carboplatin and docetaxel and Perjeta plus trastuzumab, carboplatin and docetaxel in people with HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients, run by Biocon Biologics UK Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint - Total pathologic complete response between Treatment arm A and Treatment Arm B (time frame: Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.