To study the effect of two drugs BP02-Trastuzumab and Herceptin®-EU in Patients with HER2-Positive Early Breast Cancer (EBC)and HER2-Positive Metastatic Breast Cancer (MBC)
- Conditions
- Health Condition 1: C798- Secondary malignant neoplasm of other specified sites
- Registration Number
- CTRI/2020/04/024456
- Lead Sponsor
- CuraTeQ Biologics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 690
General Inclusion Criteria
1. Female patient between 18 to 75 years of age (both inclusive) at the time of screening
2. Signed informed consent obtained prior to initiation of any study specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with study requirements
Prior current or planned treatment
3. Patients who have received adjuvant chemotherapy as part of treatment of EBC and LABC are eligible if the last dose of chemotherapy was administered at least 3 months prior to randomization.
4. Patient who has received Radiotherapy greater than or equal to 4 weeks prior to randomization should also be considered as eligible for the study provided the study target lesions must be outside the irradiated field and patients must have recovered from the radiation toxicity.
Cancer Related
5. Locally recurrent or MBC that is not amenable to curative surgery and or radiation
6.Patient with histologically or cytologically confirmed HER2 positive Metastatic Breast Cancer by immunohistochemistry (IHC 3 positive or IHC 2 positive) When the IHC result is equivocal (defined as 2 positive score) patient with a positive FISH or CISH result at screening based on either a local or central laboratory report must be available before randomization.
7. Patient with at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 at screening.
a.Tumor lesions greater or equal to 10 mm in long axis by computerized tomography (CT) scan
b.Malignant lymph nodes greater or equal to 15 mm in short axis when assessed by CT scan
8. Patient with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (both inclusive) at screening.
9. Patient with life expectancy of more than 18 months in the opinion of the investigator
Prior or concomitant conditions or procedures
10. Women of child-bearing potential must be non-lactating and have a negative pregnancy test at screening
11. Patient of childbearing potential, must agree to pregnancy prevention throughout the duration of the study
12.Females must use acceptable and effective methods of contraception such as the following
a) Two barrier methods used together (cervical cap diaphragm contraceptive sponge or vaginal spermicide plus a male or female condom)
b) Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner)
c) Tubal sterilization (tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1)
d) Intrauterine Device (IUD)
e) Progestin Implant (that is Implanon or its equivalent)
f) Progestin injection or progestin oral contraceptive pill plus one barrier method (cervical cap diaphragm contraceptive sponge or vaginal spermicide plus a male or female condom)
13. Patient with a normal left ventricular ejection fraction (LVEF) (greater or equal to 55%) at baseline as determined by either 2 dimensional echocardiogram (2 dimensional ECHO) or multiple-gated acquisition (MUGA) scan. If the patient is randomized the same method of LVEF assessment 2 dimensional ECHO or MUGA scan is required to be used throughout the study
14. Prior treatment with hormonal agents or bisphosphonates or denosumab is allowed. Bisphosphon
General Exclusion Criteria
1. Inability to comply with protocol procedures
2. Participation in another clinical trial or treatment with another investigational agent within 90 days prior to randomization
Prior, current or planned treatment
3.Patient with history of exposure to the following cumulative doses of Anthracyclines during their lifecycle
a)Doxorubicin or liposomal doxorubicin greater than 400 mg per meter square
b)Epirubicin greater than 800 mg per meter square
c)Mitoxantrone greater than 120 mg per meter square
4. Patient received prior Trastuzumab for adjuvant/ neoadjuvant therapy for breast cancer
within 1 year prior to randomization
5. Patient received any therapy prior for metastatic disease except hormonal therapy
bisphosphonates therapy for bony metastasis or osteoporosis and palliative radiotherapy for alleviating bony metastasis
Cancer Related
6. Patient has metastases to Brain and Spinal cord
7. Patient with any other cancer (that is contralateral breast cancer within 5 years prior to screening exception of treated ductal cancer or cervical cancer or basal or squamous cell cancer of skin)
Prior or concomitant conditions or procedures
8. Patient with human immunodeficiency virus, or current or chronic hepatitis B and or hepatitis C infection
9. Patient with history of known severe hypersensitivity reaction to Trastuzumab and Docetaxel or any of its excipients
10. Patient with an active, severe infection (example tuberculosis sepsis and opportunistic infections)
11. Patient with history of planned major surgery within 4 weeks prior to first dosing
12. Patient with any other medical or psychiatric condition that could compromise study participation
13. Patient with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
14. Patient with acute or active chronic infections, which, in the opinion of the Investigator may affect patient safety or participation in the study
Trastuzumab Exclusion Criteria
15 Patient with history of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
16 Patient with history of myocardial infarction or unstable angina within 6 months prior to enrolment
17 Patient with uncontrolled hypertension as per investigator’s discretion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) at week 24 defined as the proportion of patients with complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1Timepoint: Week 24
- Secondary Outcome Measures
Name Time Method Incidence nature and severity of adverse events (AE) including adverse drug reactions (ADRs) graded according to CTCAE v 5.0Timepoint: Week 100;Incidence of anti-drug (Trastuzumab) antibodies (ADA) including neutralizing antibodies (NAb).Timepoint: Week 100;overall survivalTimepoint: Week 100;Time-to-event end-points- Progression Free SurvivalTimepoint: Week 100;Trough concentrations of BP02 (Trastuzumab) and the reference productTimepoint: Week 100