A Clinical trial of Infusion of Nanosomal Docetaxel Lipid Suspension and Taxotere® in Breast Cancer Patients

Phase 2

Completed

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

• Registration Number: CTRI/2010/091/000610
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

•Patient must have histopathologically /cytologically confirmed breast cancer

•Patient must have locally advanced or metastatic breast cancer after failure of prior chemotherapy.

•Have at least one measurable lesion as per the RECIST 1.1 criteria

•Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

•Left Ventricular Ejection fraction (LVEF) greater than or equal to 50% as per Echocardiography (ECHO).

•Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator.

•No previous radiotherapy to more than 25% of marrow-containing bones.

•Previous chemotherapy/radiotherapy should be completed 4 weeks prior to start of IP administration

•Patients with life expectancy of at least 6 months

Exclusion Criteria

•Patient who has a history of hypersensitivity reactions to docetaxel or any other component of formulation or to other drugs formulated with polysorbate 80.

•Patient who has already exposed to Docetaxel injection.

•Patient in which hormone therapy is indicated as per investigatorâ??s discretion.

•Patient who has taken more than 2 prior chemotherapy treatment/regimen

•Any other condition that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study

•Patients with known CNS lesions(brain metastasis or carcinomatous meningitis)

•Known history of drug addiction within last 1 year.

Study & Design

• Study Type: Interventional
• Study Design: Not specified