Pattern of treatment and outcomes in patients with recurrent and/or metastatic triple negative breast cancer - A single institute retrospective analysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Tata Memorial Centre
- Enrollment
- 1,400
- Locations
- 1
- Primary Endpoint
- To assess the treatment pattern and outcomes in patients with recurrent unresectable and/or metastatic triple negative breast cancers.
Study Overview
Brief Summary
In India, there has been a steady increase in the incidence of breast cancer over the past decade. Breast cancer is the most common cancer among women in the urban Indian population. Around 15% of breast cancers do not express Estrogen Receptor (ER), Progesterone Receptor (PR) or Human Epidermal Growth Factor Receptor 2 (HER2) and are categorized as triple negative breast cancers (TNBC). TNBC’s show an aggressive clinical behavior and have a poor prognosis. Because of such aggressive behavior of this type of breast cancer there is an international interest in obtaining improvements in survival of these patients. Also, there is no specific guidelines available to treat metastatic TNBC. Considering the high incidence of the metastatic TNBC in India, its aggressive behavior and lack of essential data, especially in Indian settings, we propose to conduct this retrospective analysis to assess the treatment pattern and outcomes in patients with metastatic and/or recurrent TNBC. This result will form the base for future randomized control trials focusing on metastatic TNBC in India.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •All individuals above 18 years of age having histopathologically proven, recurrent and/or metastatic triple negative breast cancer (mTNBC) during the period of January 2015 to June
- •Patients could have received any number of lines of treatment in the metastatic and/or recurrent setting.
Exclusion Criteria
- •Patients with breast cancer without triple negative disease.
Outcomes
Primary Outcomes
To assess the treatment pattern and outcomes in patients with recurrent unresectable and/or metastatic triple negative breast cancers.
Time Frame: 24 months
Secondary Outcomes
- To assess the patterns of treatment used in the management of recurrent and/or metastatic TNBC.(24 months)
- To evaluate the OS in patients with recurrent and/or metastatic TNBC who are treated at the Tata Memorial Hospital and/or ACTREC during the study period.(24 months)
- To evaluate the PFS in patients with recurrent and/or metastatic TNBC who receive chemotherapy and/or Immunotherapy Targeted therapy during the mentioned study period at the Tata Memorial Hospital and/or ACTREC.(24 months)
- To assess the toxicity of treatment in included patients.(24 months)
- To assess the clinical and radiological profile in patients with metastatic TNBC.(24 months)