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 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: BIO-PERTUZ-301
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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)

  Week 18

Secondary Outcomes (38)

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

  Week 18

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

  Week 18

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

  Week 18

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

  Week 18

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

  Week 18

Study Arms (2)

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

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

Biological: Perjeta plus trastuzumab, carboplatin and docetaxel

Interventions

Perjeta plus trastuzumab, carboplatin and docetaxel BIOLOGICAL

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).

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

PERT-IJS plus trastuzumab, carboplatin and docetaxel BIOLOGICAL

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.

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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:

You may not qualify if:

• 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:
• 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:

Sponsors & Collaborators

• Biocon Biologics UK Ltd: lead

Study Sites (1)

Chopda Medicare & Research Centre Pvt. Ltd,

Nashik, 422005, India

Location

MeSH Terms

Interventions

Trastuzumab; Carboplatin; Docetaxel; pertuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 15, 2023
• Study Start: January 6, 2025
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)