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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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:

Locations
Other Locations
India
Chopda Medicare & Research Centre Pvt. Ltd,
RECRUITING
Nashik
Contact Information
Primary
Gursharan Singh, MBBS, PhD (Pharm. Medicine)
gursharan.singh@biocon.com
91 80 2808
Backup
Jayanti Panda, MBA,PM
jayanti.panda@biocon.com
91 80 2808
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2026-11-15
Participants
Target number of participants: 382
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: Biocon Biologics UK Ltd

This content was sourced from clinicaltrials.gov

Similar Clinical Trials