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.

Participation Form

 

Are you interested in participating in the TNBC study:
Yes No

 

How many patients of TNBC do you see in a month:

 

Does your hospital / site have its own Ethics Committee :
Yes No

 

 

 

 

 

 


 

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:

 

Scenario
(Drugs received by pts)
Neoadjuvant
Chemo
Adjuvant
Chemo
Metastatic
Chemo
Eligible to
participate in study
Scenario 1 Yes Yes No Yes
Scenario 2 No Yes No Yes
Scenario 3 No Yes Yes Yes
Scenario 4 No No Yes Yes
Scenario 5 No No No No
Scenario 6 Yes Yes Yes Yes
Scenario 7 Yes No No No
Scenario 8 Yes No Yes Yes

 

If interested to know more, kindly contact

Rajiv Bhattacharya – Associate Vice President – Clinical Trial Management

Toll-Free No.: 1800 123 7124

Mail Id:tnbc@lambda-cro.com