A Prospective Randomized Single Centre Parallel Design Controlled Study to Evaluate The Efficacy and Safety of DNANOSTANNA, In The treatment of (Triple Negative/HER-2 Negative) Stage III A Or III B Breast Cancer
- Conditions
- Health Condition 1: null- Stage III A Or III B Breast Cancer
- Registration Number
- CTRI/2018/02/011707
- Lead Sponsor
- Dhanvantari Nano Ayushadi Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1.Female patients between age 18 to 65 years of age with Pathologically Confirmed Invasive Breast Carcinoma Stage IIIA or IIIB
2.Triple Negative and HER-2/Neu Negative status.
3.Bi-dimensionally measurable and evaluable disease lesion.
4.No evidence of disease outside the breast or chest wall, except for ipsilateral axillary lymph nodes
5.Subject willing to participate by providing written informed consent
6.Life expectancy must be >= 6 months
7.(Eastern Cooperative Oncology Group) ECOG performance status with 0 or 1
8.Chest computed tomography (CT) Scan without evidence of metastasis at the time of screening
9.Laboratory value must be as follows:
White Blood Cells >= 3,000/mm3
Neutrophils >= 2,000/mm3
Hemoglobin >= 8 g/dL
Platelets >= 100,000/mm3
Serum creatinine <=1.5 Ã? Upper normal limit (UNL)
Alkaline phosphatase <=1.5 Ã? Upper normal limit (UNL)
Total serum bilirubin <= 1.5 Ã?UNL for the institution.
SGOT <=1.5 Ã? Upper normal limit (UNL)
(SGPT) <=1.5 Ã? Upper normal limit (UNL)
Serum Calcium <= ULN
10.Pregnancy test must be negative.
11.Subject with child bearing potential must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study
1.Prior systemic treatment for Breast cancer with hormonal therapy, chemotherapy, or any other anticancer therapy.
2.Prior radiation therapy.
3.Participants who received or receiving or scheduled to receive post-operative radiotherapy.
4.History of a malignancy other than Breast cancer
5.Participants taking alternative therapies for cancer must stop taking these therapies prior to randomization. Alternative therapies are not allowed during the treatment or follow-up portions of the study.
6.Peripheral neuropathy >= Grade 2.
7.Electrocardiogram (ECG) with significant abnormalities (as determined by the investigator)
8.Participants who are medically unstable, including but not limited to active infection, acute hepatitis, gastrointestinal bleeding, uncontrolled cardiac arrhythmias, interstitial lung disease, inflammatory bowel disease, uncontrolled angina, uncontrolled hypercalcemia, uncompensated congestive heart failure, uncontrolled diabetes, dementia, seizures, superior vena cava syndrome.
9.Positive Serological test for HIV, viral hepatitis (B, C).
10.History of drug or alcohol dependence or abuse during the last 1 year prior to randomization
11.Have participated in an investigational trial within 30 days prior to enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety profile, number of patients experienced adverse events by NCI Toxicity Criteria at every Course. <br/ ><br> <br/ ><br>Timepoint: Visit 1 (Week -2) to Visit 6 (Week 12) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Efficacy of the DNANOSTANNA in terms of response rate in participating breast cancer patients assessed by Radiographic Evaluation by RECIST Criteria. <br/ ><br>2.Improvement in Quality of life comparing baseline with end of studyTimepoint: 1.Visit 1 (Week -2) to Visit 6 (Week 12) <br/ ><br>2.Visit 2 (Week 0) to Visit 6 (Week 12)