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

NCT ID: NCT06038539

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 382 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2026-11-15

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

PERT-IJS plus trastuzumab, carboplatin and docetaxel

Intervention Type: 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 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

Group Type: ACTIVE_COMPARATOR

Perjeta plus trastuzumab, carboplatin and docetaxel

Intervention Type: 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).

Interventions

PERT-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.

Intervention Type: BIOLOGICAL

Perjeta 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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biocon Biologics UK Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chopda Medicare & Research Centre Pvt. Ltd,

Nashik, , India

Site Status: RECRUITING

Countries

India

Central Contacts

Gursharan Singh, MBBS, PhD (Pharm. Medicine)

Role: CONTACT

gursharan.singh@biocon.com

91 80 2808 ext. 5479

Jayanti Panda, MBA,PM

Role: CONTACT

jayanti.panda@biocon.com

91 80 2808 ext. 5304

Facility Contacts

Nagesh Madnoorkar

Role: primary

nageshmadnoorkar@gmail.com

9822353986

Other Identifiers

BIO-PERTUZ-301

Identifier Type: -

Identifier Source: org_study_id