A clinical study to compare the efficacy, safety and immunogencity of two formulations of trastuzumab in women with HER2 Positive Early breast cancer.
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2019/01/017029
- Lead Sponsor
- Tanvex Biologics Corp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Signed written informed consent.
2. Females � 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 â�¥ 1,500/�¼L
- Hemoglobin � 9 g/dL
- Platelet count â�¥ 100,000/�¼L
- Creatinine clearance � 40 mL/min
- Total bilirubin � 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine
aminotransferase (serum glutamic pyruvic transaminase) � 2.5 x ULN
- Alkaline phosphatase � 5 x ULN
11. LVEF � 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br>(ypT0/Tis ypN0), in subjects with human epidermal growth factor receptor positive (HER2+) invasive early <br/ ><br>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 Outcome Measures
Name Time Method 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 <br/ ><br>investigator.