Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: TX05: Participant will receive TX05 (biosimilar of Trastuzumab) during 8 cycles (a cycle is a period of 3 weeks).
All participants will receive epirubicin at 75 mg/m2 plus cycloposphami
Sponsors
Tanvex Biologics Corp
Fermish Clinical Technologies Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent. 2. Females ââ?°Â¥ 18 years of age. 3. Histologically confirmed HER2 overexpressing invasive primary operable Stage II/IIIa breast cancer by American Joint Committee on Cancer 7th Edition staging criteria. Tumor tissue sample must be available for central analysis. 4. Planned surgical resection of breast tumor (lumpectomy or mastectomy, and SN biopsy or ALND). 5. Planned neoadjuvant chemotherapy. 6. HER2 overexpression as assessed by: - Gene amplification by fluorescent in-situ hybridization (FISH), chromogenic in-situ hybridization (CISH), or dual in-situ hybridization (DISH) (as defined by the manufacturerââ?¬•s kit instruction); OR - Overexpression by immunohistochemistry (IHC) categorized as IHC 3+; OR - Overexpression by immunohistochemistry categorized as IHC2+ with FISH, CISH, or DISH confirmation. 7. Ipsilateral, measurable tumor longest diameter > 2 cm. 8. Known estrogen receptor (ER) and progesterone receptor (PR) hormone status prior to randomization. If ER/PR status is not available locally, testing may be performed by central laboratory during Screening. 9. ECOG performance status of 0 or 1. 10. Adequate bone marrow, hepatic, and renal functions as evidenced by the following: - Absolute neutrophils count ââ?°Â¥ 1,500/Ã?¼L - Hemoglobin ââ?°Â¥ 9 g/dL - Platelet count ââ?°Â¥ 100,000/Ã?¼L - Creatinine clearance ââ?°Â¥ 40 mL/min - Total bilirubin ââ?°Â¤ 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) ââ?°Â¤ 2.5 x ULN - Alkaline phosphatase ââ?°Â¤ 5 x ULN 11. LVEF ââ?°Â¥ 50% or within the normal level of the institution, as assessed by echocardiography or MUGA scan. 12. Able to comply with the study protocol. 13. Female subjects of childbearing potential must have a negative serum pregnancy test within 1 week of first administration of study drug and agree to use effective contraception (hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) throughout the study period and for 6 months after last administration of study drug.
Exclusion criteria
Exclusion criteria: 1. Participation in any interventional clinical study or having taken any investigational therapy during the 2 month period immediately preceding administration of the first dose of study drug. 2. Bilateral breast cancer. 3. Inflammatory breast cancer. 4. Metastases. 5. Previous chemotherapy, biologic therapy, radiation, or surgery for any active malignancy, including breast cancer. 6. Subjects with one or more of the following conditions: - Cardiac insufficiency (New York Heart Association III or IV); myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia, or pulmonary embolus within the previous 12 months prior to the first administration of study drug. - Clinically significant active infection. - Poorly controlled diabetes mellitus. - Uncontrolled hypertension (blood pressure > 150/100 mmHg despite optimal medical therapy). - Major surgery, significant traumatic injury, or radiation therapy within 4 weeks of first administration of study drug. - Grade 3 hemorrhage within 4 weeks of first administration of study drug. 7. Pre-existing clinically significant (� Grade 2) peripheral neuropathy. 8. History of malignancy within the last 5 years, except adequately excised squamous or basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer. 9. Severe dyspnea at rest requiring supplementary oxygen therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the therapeutic equivalence of TX05(biosimilar of Trastuzumab) to Herceptin based on the pCR rate following neoadjuvant chemotherapy,defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (ypT0/Tis ypN0), in subjects with human epidermal growth factor receptor positive (HER2+) invasive early breast cancer.Timepoint: The study will consist of a Screening period (Days -28 to 0), and 8 cycles of neoadjuvant treatment (Week 0 [Day 1] to Week 24), followed by surgery (3 to 7 weeks from the 1st day of the last cycle/last dose of study drug). | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare objective response rate (ORR) between the 2 treatment arms;immunogenicity, safety, and tolerability will also be assessed.Timepoint: ORR, according to RECIST version 1.1, as assessed by the investigator. | — |
Countries
Belarus, Brazil, Bulgaria, Chile, Georgia, Hungary, India, Italy, Mexico, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, Thailand, Ukraine
Contacts
Public ContactDr Gursimran Kaur
JSS Medical Research India Private Limited
Outcome results
None listed