A Clinical Trial to evaluate the Efficacy and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension and Taxol in Metastatic 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.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001344

Enrollment

120

Registered

2010-10-18

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: NPLS (Nanosomal Paclitaxel Lipid Suspension) Arm A: 175 mg/m2 intravenous Infusion for 3 hours (+30 minutes) every 3 weeks for a maximum of 6 cycles Intervention2: NPLS (Nanosomal Pacli

Eligibility

Inclusion criteria

Inclusion criteria: The patient is willing to give written, signed and dated, informed consent to participate in the study before initiating any study related procedures Patient must have histopathologically /cytologically confirmed breast cancer Patient must have metastatic breast cancer after failure of prior combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated Patient with adequate bone marrow, renal and hepatic function

Exclusion criteria

Exclusion criteria: Patient who has a history of hypersensitivity reactions to drugs formulated with Cremophor EL. Patient who was previously exposed to Taxane Injection Patient who has taken more than 1 prior chemotherapy treatment/regimen for metastatic breast cancer

Design outcomes

Primary

Measure	Time frame
To compare the Overall Response Rate (CR or PR) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly or every-3-week regimen) and TaxolÂ® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapyTimepoint: 18 weeks	—

Secondary

Measure	Time frame
To evaluate safety of the patients of each arm who are exposed to the investigational medicinal product 2.To compare the Disease Control Rate (CR or PR or SD) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly or every-3-week regimen) and TaxolÂ® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapyTimepoint: 18 weeks for Disease Control Rate (CR or PR or SD) and at each visit for safety analysis	—

Measure

Time frame

To evaluate safety of the patients of each arm who are exposed to the investigational medicinal product 2.To compare the Disease Control Rate (CR or PR or SD) for evaluation of the efficacy of Nanosomal Paclitaxel Lipid Suspension (given as weekly or every-3-week regimen) and TaxolÂ® (given as every-3-week regimen) in patients with metastatic breast cancer after failure of prior chemotherapyTimepoint: 18 weeks for Disease Control Rate (CR or PR or SD) and at each visit for safety analysis

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Countries

India

Contacts

Public ContactDr Praveen Shetty

Lambda Therapeutic Research Ltd

praveenshetty@lambda-cro.com07940204020

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 8, 2026