Lambda Therapeutic Research Limited is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad. With experience in major disease areas, sound scientific and regulatory knowledge, our teams have a successful track record of conducting clinical trials across various therapeutic areas, with a major focus on Oncology.
Among all the types of breast cancer, Triple Negative Breast Cancer (TNBC) is one of the most challenging to treat. With an aim to develop a better therapy for patients with TNBC, Lambda has initiated a clinical trial at more than 40 sites across India.
A Subject of Concern
In India, breast cancer is the most frequently diagnosed cancer in women accounting for 27% of all cancer cases and 3 out of every 10 patients with breast cancer have Triple Negative Breast Cancer (TNBC).
We invite you to BE a HERO and support this trial by registering as an investigator or referring patients for this trial.
A global, multicenter, three arms, open-label randomized study to evaluate the efficacy and safety of Nanosomal Docetaxel Lipid Suspension compared to Taxotere® (Docetaxel Injection Concentrate) in triple-negative breast cancer patients with locally advanced or metastatic breast cancer after failure to prior chemotherapy.
Key Inclusion Criteria
- Patient must have histopathologically/cytologically confirmed triple-negative breast cancer. TNBC status should be based on history of the patients.
- Patients may have received one prior chemotherapy regimen for adjuvant therapy and/or one chemotherapy treatment/regimen for first-line metastatic therapy
- Patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.
- Having at least one measurable lesion along with ECOG ≤ 2 and LVEF ≥ 50%
Key Exclusion Criteria:
- Patient who has a history of hypersensitivity reactions to Docetaxel.
- Patient who is already exposed to Docetaxel injection in metastatic setting.
- Patients with known CNS lesions except for asymptomatic brain metastases.
- Patient with evidence of abnormal cardiac conduction or history of cardiac disease.
The Scenarios pertaining to the eligibility of patients for the study:
(Drugs received by pts)
participate in study
If interested to know more, kindly contact
Rajiv Bhattacharya – Associate Vice President – Clinical Trial Management
Toll-Free No.: 1800 123 7124