A Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)

NCT05283837 | Completed Phase 3

• 1 other identifier: PERT.21.001
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficacy, safety, pharmacokinetic, and immunogenicity of Pertuzumab (Test, Cadila Healthcare Ltd.,) plus Trastuzumab and Docetaxel versus Pertuzumab (Reference, Genentech Inc.,) plus Trastuzumab and Docetaxel treatment in previously untreated patients with HER2 positive MBC.

Conditions

Metastatic Breast Cancer

Keywords

HER2 Positive; PERTUZUMAB; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Compare Overall Response Rate (ORR) (According to Response Evaluation Criteria in Solid Tumor [RECIST] 1.1 Criteria) at day 127 from baseline

  from time of First treatment to Day 127

Secondary Outcomes (5)

• Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)

  During Cycle 1(each cycle is of 21 days)

• The area under the serum concentration versus time curve from time zero to infinity (AUC0-inf)

  During Cycle 1(each cycle is 21 days)

• maximum measured serum concentration observed after a single dose at cycle 1 (Cmax)

  During Cycle 1(each cycle is 21 days)

• Time of the maximum measured serum concentration (Tmax)

  During Cycle 1(each cycle is 21 days)

• serum trough concentration of ZRC-3277 (Pre-Dose)

  Pre-dose on Day 1 of Cycle 1,2,3,4,5 and 6. (each cycle is of 21 days)

Study Arms (2)

Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)

EXPERIMENTAL

Pertuzumab (ZRC-3277) will be administered at a loading dose of 840 mg via IV infusion over 60 minutes (± 10 minutes) in Cycle 1 followed by 420 mg via IV infusion over 30 to 60 minutes in subsequent cycles then be given every 3 weeks, starting 3 weeks later till cycle 6.

Biological: Pertuzumab (ZRC-3277)

Pertuzumab (Perjeta®, a product of Genentech, Inc.,)

ACTIVE COMPARATOR

Perjeta® will be administered at a loading dose of 840 mg via IV infusion over 60 minutes (± 10 minutes) in Cycle 1 followed by 420 mg via IV infusion over 30 to 60 minutes in subsequent cycles then be given every 3 weeks, starting 3 weeks later till cycle 6.

Biological: Pertuzumab (Perjeta®)

Interventions

Pertuzumab (ZRC-3277) BIOLOGICAL

Pertuzumab in combination with Trastuzumab and Docetaxel will be administered via intravenous (IV) infusion every 3 weeks for 06 cycles.

Pertuzumab (ZRC-3277, Cadila Healthcare Ltd.,)

Pertuzumab (Perjeta®) BIOLOGICAL

Pertuzumab in combination with Trastuzumab and Docetaxel will be administered via intravenous (IV) infusion every 3 weeks for 06 cycles.

Pertuzumab (Perjeta®, a product of Genentech, Inc.,)

Eligibility Criteria

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

You may qualify if:

• Female patients 18 to 65 years of age (both inclusive).
• Patient with pathologically (histologically or cytologically) confirmed, adenocarcino-ma metastatic breast cancer and candidate for chemotherapy. Note: Patients with de-novo Stage IV disease are eligible.
• With at least one measurable metastatic target lesion (based on RECIST criteria, ver-sion 1.1).
• Documentation of following prior to randomization:
• Documentation of HER2 gene amplification by fluorescent in situ hybridiza-tion (FISH); as defined by a ratio \>2.0) OR documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation) (estrogen receptor/progesterone receptor positive subjects may be enrolled if they are HER2 positive) prior to randomization, see Section 6.4 for detailed criteria)
• Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
• Left ventricular ejection fraction (LVEF) of ≥ 50% at baseline (within 42 days of ran-domization) as measured by echocardiography (ECHO) or multiple gated acquisition (MUGA). Note: ECHO is the preferred method. If the patient is randomized, the same method of LVEF assessment (i.e., ECHO or MUGA) must be used throughout the study and it should preferably be obtained at the same institution and preferably by the same assessor)
• Patient able to understand and willing to give the informed consent and able to com-ply with the requirements of the study protocol.
• A woman of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin \[β-hCG\]) at screening and urine β-hCG test at random-ization.
• Woman of child-bearing potential must agree to use adequate contraceptive methods that is highly effective (with a failure rate of \<1% per year), with low user dependen-cy when used consistently and correctly, during the intervention period and for at least 7 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during the study and for a period of 7 months. The investigator should evaluate the effectiveness of the contraceptive meth-od in relationship to the first dose of study intervention.

You may not qualify if:

• History of anticancer therapy for MBC, with the exception of single prior hormonal regimen for MBC, which must be stopped prior to randomization.
• Note 1: Anticancer therapy for MBC includes any epidermal growth factor receptor or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen for MBC Note 2: Single prior hormonal regimen for MBC may include more than one hormo-nal therapy. If a patient is switched to a different hormonal therapy because of dis-ease progression, this will be counted as two regimens, and the patient will not be eli-gible for the study. If a patient is switched to a different hormonal therapy for reasons other than disease progression (e.g., toxicity or local standard practice), this will be counted as single regimen.
• History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of \< 12 months.
• History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant set-ting.
• Patients with CNS metastases, except for treated asymptomatic CNS metastases, pro-vided all of the following criteria are met:
• Only supra-tentorial metastases allowed (i.e., no metastases to midbrain, pons, medulla, or spinal cord)
• No evidence of interim progression or hemorrhage after completion of CNS-directed therapy
• No ongoing requirement for corticosteroids as therapy for CNS disease (anti-convulsants at a stable dose are allowed)
• No stereotactic radiation within 14 days or whole-brain radiation within 28 days prior to randomization
• Leptomeningeal disease (i.e. carcinomatous meningitis)
• History of persistent Grade ≥ 2 hematologic toxicity resulting from previous neoad-juvant or adjuvant therapy (all grades based on National Cancer Institute Common Toxicity Criteria for Adverse Events, Version 5.0 \[NCI CTCAE v 5.0\]).
• Current peripheral neuropathy of NCI-CTCAE, Version 5.0, Grade ≥ 3 at randomiza-tion.
• Have a history of congestive heart failure (CHF) of any New York Heart Association (NYHA) criterion, or serious cardiac arrhythmia requiring treatment (except for atrial fibrillation, paroxysmal supraventricular tachycardia).
• History of myocardial infarction within 6 months before randomization.
• Current uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or dias-tolic blood pressure \>100 mmHg), or unstable angina.

Sponsors & Collaborators

• Zydus Lifesciences Limited: lead

Study Sites (1)

Unique Hospital-Multispeciality & Resesarch Institute

Sūrat, India

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr Deven Parmar, MD

  Zydus Lifesciences Ltd (formerly Known as Cadila Healthcare Ltd)

  STUDY DIRECTOR

Study Design

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

Model Details: Randomized, Multi-center, Comparative, Double-blind, Parallel study

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 17, 2022
• Study Start: September 26, 2022
• Primary Completion: September 6, 2023
• Study Completion: September 6, 2023
• Last Updated: July 18, 2024

Record last verified: 2022-02

Locations

IN (1)