A clinical trial to study the effect of low-dose chemotherapy drugs targeting tumor cells and other tumor-supporting cells to enhance the efficacy of immunotherapy drugs in breast cancer patients
- Conditions
- Health Condition 1: C50- Malignant neoplasm of breast
- Registration Number
- CTRI/2024/04/066324
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Women aged 18 and above with Breast Cancer of the subtypes Luminal B Her2-ve and TNBC
2.Women with advanced stages of Luminal B Her2-ve and TNBC that are inoperable but non-metastatic
3.Women with Luminal B Her-ve and TNBC that are eligible for NACT
Exclusion Criteria:
1.Women with early-stage Luminal B Her-ve and TNBC tumors that are taken up for primary surgery will be excluded
2.Women with Luminal B tumors that are HER2 positive will be excluded
3.Women with Luminal A tumors will be excluded
4.Women with the above subtypes of BC having HIV, HCV, and HBV infections will be excluded from the study
5.Women undergoing treatment for BC or any other types of cancer will be excluded
6.Women with any other cancers will be excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response assessed by histopathology.Timepoint: Baseline to end of surgery
- Secondary Outcome Measures
Name Time Method Progression free survival at 3 years <br/ ><br> <br/ ><br>Overall survival at 5 years <br/ ><br> <br/ ><br>New biomarkers for screening of tumour microenvironment <br/ ><br> <br/ ><br>Timepoint: 4 to 6 months