A Clinical Study to evaluate the Effectiveness and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension in comparison with Taxol in Breast cancer patients.

An Open Label, Randomized, Multiple-Dose, Parallel Study to Evaluate Efficacy and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension (Intas Pharmaceuticals Ltd.) and TaxolÂ® (Paclitaxel Injection Concentrate, Bristol-Myers Squibb.) in Metastatic Breast Cancer Patients after failure of prior chemotherapy. - NA

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/07/006062

Enrollment

Registered

2015-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Nanosomal Paclitaxel Lipid Suspension for Injection 1 mg/ mL: Dose:175 mg/m2,Frequency:Every 3 weeks,Mode of Administration:IV,Duration of treatment:4 Months Control Intervention1: Taxo

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patient willing to give written, signed and dated, informed consent to participate in the study before initiating any study related procedures 2. Patient must have histopathologically /cytologically confirmed breast cancer 3. Have at least one measurable lesion as per the RECIST criteria (Version 1.1) 4. Patients with life expectancy of at least 6 months. 5. Patient must have negative serum pregnancy test at screening

Exclusion criteria

Exclusion criteria: 1. Patient who has already exposed to Taxane Injection 2. Any of the following cardiac conditions: • Unstable angina • Myocardial infarction within the past 6 months • Severe uncontrolled ventricular arrhythmias • Clinically significant pericardial disease • Electrocardiographic evidence of acute ischemia or active conduction system abnormality • History of cardiac disease that met the NYHA Classification class 2 or greater 3. Known history of drug addiction within last 1 year 4. Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).

Design outcomes

Primary

Measure	Time frame
To compare the Best overall response rate (CR or PR) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension and TaxolÂ® in patients with metastatic breast cancer.Timepoint: To end of the study.	—

Secondary

Measure	Time frame
1. To evaluate safety of the patients of each arm who are exposed to the investigational medicinal product. 2. To compare the Disease Control Rate.Timepoint: To end of the study.	—

Countries

India

Contacts

Public ContactDr Ankit Ranpura

Lambda Therapeutic Research Ltd.

ankitranpura@lambda-cro.com07940202074

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026