A Prospective Randomized Single Centre Parallel Design Controlled Study to Evaluate The Efficacy and Safety of DNANOSTANNA Herbal Formulation Prepared Through Green Nanotechnology In The treatment of (Triple Negative/HER-2 Negative) Stage IIIA Or IIIB Breast Cancer

Dhanvantari Nano Ayushadi Private Limited0 个研究点目标入组 6 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

发起方

Dhanvantari Nano Ayushadi Private Limited