A clinical research to study the safety, efficacy and immunogenicity of test pertuzumab in metastatic breast cancer patients.

Phase 3

Conditions: Health Condition 1: C50-C50- Malignant neoplasms of breast

Registration Number: CTRI/2023/05/052997

Lead Sponsor: Enzene Biosciences Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Female patients 18 to 65 years of age (both inclusive).

2. Patient with pathologically (histologically or cytologically) confirmed breast cancer with

stage IV i.e. Metastatic disease, atleast M1 as per AJCC TNM classification

3. With at least one measurable metastatic target lesion (based on RECIST criteria,

version1.1).

4. Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH); as

defined by a ratio >2.0) OR documentation of HER2-overexpression by

immunohistochemistry (IHC) (defined as IHC3+, or IHC2+ with FISH confirmation)

5. Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 2.

6. Left ventricular ejection fraction (LVEF) of = 50% at screening visit

7. Has life expectancy of at least 6 months from screening

8. Patient willing to provide written informed consent.

Exclusion Criteria

1. History of severe hypersensitivity reaction to Pertuzumab, Trastuzumab or Docetaxel or

any of its excipients

2. Prior systemic therapy for metastatic disease, including cytotoxic chemotherapy, or

previous anticancer therapy with signal transduction inhibitors (e.g. Lapatinib), biological

drugs (e.g. Trastuzumab and Bevacizumab), experimental drugs (not approved for breast

cancer therapy, anticancer drugs (except prior single hormonal therapy)

3. 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

4. History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any

treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting.

5. Has received cumulative doses of anthracycline, exceeding 360 mg/m2 of BSA for

doxorubicin, 720 mg/m2 of BSA for epirubicin, 120 mg/m2 of BSA for mitoxantrone, and

90 mg/m2 of BSA for idarubicin.

6. Has active and uncontrolled metastasis to central nervous system

7. Has bone metastasis as the only measurable tumor

8. Has Preexisting Grade 3 or higher sensory or motor peripheral neuropathy at

randomization.

9. Has history of congestive heart failure of any New York Heart Association (NYHA) class,

serious cardiac arrhythmia requiring treatment, unstable angina pectoris, and/or myocardial

infarction within 6 months prior to screening

10. Has uncontrolled hypertension at screening (i.e. SBP = 140 mmHg and/or DBP = 90mmHg)

11. Has severe dyspnea at rest or requiring supplementary oxygen therapy

12. Has undergone any prior mediastinal irradiation (except internal mammary node

irradiation) for the present breast cancer

13. Patient’s having the following laboratory results at screening

a. Absolute neutrophil count (ANC) < 1,500/mm3

b. Hemoglobin (Hb) < 9 g/dL

c. Total Leucocyte count < 3000/mm3

d. Platelet count < 100,000/mm3

e. Total bilirubin level >1.5 times the upper limit of the normal laboratory range

(ULN)( > 2.5 times ULN in patients with liver metastases)

f. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3.0

x upper limit of normal (ULN) ( >5 x ULN in patients with liver metastases)

g. Alkaline phosphatase > 2.5 x ULN ( > 5.0 x ULN if liver or bone metastases are present)

h. Serum Creatinine level > 1.5 times ULN

14. Patients suffering from acute or chronic infection(s)

15. Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and

hepatitis C virus (HCV) at screening

16. Female patients of childbearing potential not willing to implement adequate non-hormonal

contraceptive measures during the study period

17. Patients who are pregnant or nursing

18. Major surgical procedure or significant traumatic injury within 28 days prior to study

treatment start or anticipation of the need for major surgery during the course of study

treatment

19. Has any concurrent disease or condition, which in the opinion of the investigator does not

allow participation of the patient in this study

20. Has partici

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of biosimilar Pertuzumab versus innovator Pertuzumab in Previously <br/ ><br>Untreated Patients with HER2 Positive Metastatic Breast Cancer by assessment of DCRTimepoint: 1. All patients completed 9 Week of treatment. <br/ ><br>2. All patients completed 18 week of treatment.

Secondary Outcome Measures

Name	Time	Method
1. Overall Response Rate (ORR) <br/ ><br>2. Pharmacokinetics (PK) profile of biosimilar Pertuzumab versus Innovator Pertuzumab <br/ ><br>(Perjeta®, Genentech Inc.,). <br/ ><br>3. Immunogenicity potential of biosimilar Pertuzumab and comparison with Perjeta <br/ ><br>Innovator Pertuzumab by assessment of anti-pertuzumab antibody <br/ ><br>4. Safety and tolerability of the investigational productTimepoint: Overall Response Assessment- Week 9 and Week 18 <br/ ><br>Anti-Pertuzumab Antibody(ADA)- Visit 2, Visit 8 <br/ ><br>PK Assessment- Visit 2