Combinatorial therapy of antibody and anticancer drug vs monotherapy of either agent against a type of cancer (KRAS mutated)

Phase 2

Completed

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2021/09/036766
• Lead Sponsor: Agastiya Biotech LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Best Overall Response (OR) Time Frame Up to3months <br/ ><br>Duration of Overall Response Time Frame Up to 3 months <br/ ><br>Progression Free Survival(PFS) Time Frame Up to3months <br/ ><br>Safety evaluation <br/ ><br>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.