Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: ABOO1 along with Chemotherapy: (1E, 4E, 6E)-1-(3, 5-dimethoxyphenyl)- 7-(4-hydroxy-3,
5dimethoxyphenyl) hepta- 1, 4, 6-trien-3-one
ABOO1 - 400 mg Twice a Day (BD) Morning and Night, Ro
Sponsors
Agastiya Biotech LLC
VOPEC PHARMACEUTICALS PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ageââ?¬â??18 to70 years(female) 2.Patients with advanced Triple Negative Breast Cancer (TNBC) and KRAS mutated Cancer by testing (HER2, ER, PR and KRAS expression), not amenable to surgical therapy. 3.Eligible for taxane monotherapy. 4.No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic breast Cancer (TNBC). 5.Patients must have measurable disease on radiological imaging PET scan to monitor treatment response. Measurable disease, as defined by RECISTv1.1. 6.Women of child bearing potential must agree to either use a contraceptive method or to remain abstinent during the treatment period and for at least 5 months after the last dose of study drug, or for at least 6 months after the last dose of paclitaxel. 7.Life expectancy > 24 weeks 8.Patient should be willing to undergo all treatment related procedures and investigations 9.PatientshouldbewillingandreadyforPETScanand/orCTand/orUSGand/orMRIand follow-up scans 10.Patient is willing to take and to tolerate cytotoxic drugs Willing to sign informed consent form
Exclusion criteria
Exclusion criteria: 1.Patients above 70yr sage 2.Pregnant or lactating women, or intending to become pregnant during the study. 3.Life threatening comorbidities suchas HIV, HPV, HBV, HCV, Tuberculosis ,CHF, Impaired Hepaticor Renal Function oranypsychological deficits etc. 4.Known CNS disease, except for treated asymptomatic CNS metastases. 5.Uncontrolled pleural effusion, pericardial effusion, orascites 6.Uncontrolled tumor-related pain 7.Significant cardiovascular disease, such as New York Heart As Standard of Careiation (NYHA) cardiac disease (Class II or greater), MI within 3 months prior to randomization, unstable arrhythmias, or unstable angina. 8.Major surgical procedure within 4weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis. 9.History of autoimmune disease. 10.Prior allogeneic stem cell or solid organ transplantation 11.Poor peripheral venous access Patients not suitable for study as per investigators opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate Complete Response (CR) with Partial Response (PR) with Stable Disease (SD) Tumor Reduction Time Frame Up to3monthsTimepoint: baseline, 4 weeks and 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Overall Response (OR) Time Frame Up to3months Duration of Overall Response Time Frame Up to 3 months Progression Free Survival(PFS) Time Frame Up to3months Safety evaluation Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) Time Frame From Day 1 to last dose of study drugTimepoint: Secondary outcome: all-cause mortality at 1 year, 3 years), or may involve a different event, variable, or experience altogether. | — |
Countries
India
Contacts
Public ContactS Kumar
Vopec Pharmaceuticals Pvt Ltd
Outcome results
None listed