Health Condition 1: null- Stage III A Or III B Breast Cancer
Conditions
Interventions
Intervention1: Treatment Arm A: Doxorubicin Injection 60 mg/m2 every 3 weeks as a 1 hour intravenous infusion with cyclophasphamide Injection 600 mg/m2 every 3 weeks as a 1 hour intravenous infus
Sponsors
Dhanvantari Nano Ayushadi Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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 Alkaline phosphatase Total serum bilirubin SGOT (SGPT) Serum Calcium 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety profile, number of patients experienced adverse events by NCI Toxicity Criteria at every Course. Timepoint: Visit 1 (Week -2) to Visit 6 (Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy of the DNANOSTANNA in terms of response rate in participating breast cancer patients assessed by Radiographic Evaluation by RECIST Criteria. 2.Improvement in Quality of life comparing baseline with end of studyTimepoint: 1.Visit 1 (Week -2) to Visit 6 (Week 12) 2.Visit 2 (Week 0) to Visit 6 (Week 12) | — |
Countries
India
Contacts
Public ContactVidya Anand
Dhanvantari Nano Ayushadi Private Limited
Outcome results
None listed