A study of Pertuzumab in breast cancer patients

Phase 3

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2022/12/048133
• Lead Sponsor: Intas Pharmaceuticals Ltd Biopharma Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Study participants must voluntarily provide written informed consent indicating that he or she understands the purpose of, and procedures required for the study and is willing to participate in the study.

2.Female participants must be 18 years and older of age, at the time of signing the informed consent.

3.Participants who are medically stable on the basis of physical examination, medical history, and 12-lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participants source documents and initialed by the investigator.

4.Participants who are medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participants source documents and initialed by the investigator.

5.Histologically or cytologically confirmed adenocarcinoma of the breast with the following: -Is locally recurrent or metastatic disease, and candidate for systemic chemotherapy

-Is not amenable to resection with curative intent (curative surgery and/or radiation).-With at least one measurable lesion (based on RECIST criteria, version 1.1).Note: Particpants with de-novo Stage IV disease are eligible. Bone and skin lesions, as well as lesions that were irradiated, biopsied or had any form of local intervention or surgical manipulation are only to be assessed as non-target lesions. Baseline imaging scans must have been performed in the 4 weeks preceding randomization.

6.Documentation of HER2 gene amplification by fluorescent in situ hybridization (FISH); as defined by a ratio greater than 2.0) or documentation of HER2-overexpression by immunohistochemistry (IHC) (defined as IHC3 positive, or IHC2 positive with FISH confirmation) as assessed on primary tumor and/or metastatic site as determined in a local laboratory prior to randomization according to American Society of Clinical Oncology – College of American Pathologists (ASCO-CAP) guidelines.

7.Left Ventricular Ejection Fraction (LVEF) greater than or equal to 50 percent at baseline (within 42 days of randomization) as determined by either ECHO or MUGA. History of LVEF decline to below 50 percent during or after prior trastuzumab adjuvant or neo-adjuvant therapy will not be eligible.Note: ECHO is the preferred method. If the participant is randomized, the same method of LVEF assessment, ECHO or MUGA, must be used throughout the study, and to the extent possible, be obtained at the same institution.

8.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

9.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

-Is not a woman of childbearing potential (WOCBP)

OR -Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of less than 1percent per year), with low user dependency when used consistently and correctly, as described in Appendix 10.4 during the intervention period and for a

Exclusion Criteria

1.History of clinically significant liver or renal insufficiency clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, metabolic disturbances, wound healing disorders, ulcers, or bone fractures as determined by the investigator.

2.Known allergies, hypersensitivity, or intolerance to study drugs or its excipients.

3.History of anticancer therapy for metastatic breast cancer or locally recurrent breast cancer (with the exception of one prior hormonal regimen for MBC).This includes any EGFR or anti-HER2 agents or vaccines, cytotoxic chemotherapy, or more than one prior hormonal regimen for MBC.

Note One prior hormonal regimen for MBC may include more than one hormonal therapy, for example, if the switch is not related to disease progression, such as toxicity or local standard practice, this will be counted as one regimen. If a participant receives hormonal therapy for MBC and is switched to a different hormonal therapy due to disease progression, this will be counted as two regimens and the participant is not eligible.

4.History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab and or or lapatinib used in the neoadjuvant or adjuvant setting.

5.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 within 12 months.

6.History of persistent Grade greater than or equal 2 hematologic toxicity as per NCI-CTCAE, Version 5.0 resulting from previous adjuvant therapy.

7.Current peripheral neuropathy of NCI-CTCAE, Version 5.0, Grade greater than or equal 3 at screening.

8.Current clinical or radiographic evidence of central nervous system metastases. Brain scan at screening or baseline is not mandatory. In case of clinical suspicion brain scan can be performed based on investigator judgment.

9.History of exposure to the following cumulative doses of anthracyclines

-doxorubicin or liposomal doxorubicin greater than 360 mg per m2

-epirubicin greater than 720 mg per m2

-mitoxantrone greater than 120 mg per m2 and idarubicin greater than 90 mg per m2

-Other (e.g., liposomal doxorubicin or other anthracycline greater than the equivalent of 360 mg per m2 of doxorubicin)

-If more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 360 mg per m2 of doxorubicin.

10.Current uncontrolled hypertension (systolic greater than 150 mmHg and or or diastolic greater than 100 mmHg).

11.Participant with known history or current symptoms of any of the following clinically significant cardiac conditions within the past 6 months prior to screening

-Unstable angina or myocardial infarction

-New York Heart Association (NYHA) functional classification for cardiac disease of Class II or greater

-High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate greater than or equal to 100 per min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block, such as second degree AV-block Type 2 (Mobitz 2) or third-degree AV-block).-Clinically significant pericardial disease -Electrocardiographic evidence of acute ische

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish therapeutic equivalence between Intas Pertuzumab versus Perjeta (in combination with Trastuzumab and Docetaxel) in participants with HER2-positive metastatic breast cancer.Timepoint: To compare the independently assessed Objective Response Rate (i.e., CR plus PR) using Response Evaluation Criteria in Solid Tumours- Revised RECIST guideline (version 1.1) at Week 24.