Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Low dose chemotherapy drug: A)Trial Objective 1:
Interventional Arm: Capecitabine 500 mg x Bid per oral for 2 weeks
Cyclophosphamide 50 mg x Bid per oral for 2 weeks followed by Standard of care for triple-negative and luminal B/Her2-ve breast cancer patients
B)Trial Objective 2
Based on the objective two results,
Sponsors
Indian Council of Medical Research
Dr Vijayakumar D K
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response assessed by histopathology.Timepoint: Baseline to end of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival at 3 years Overall survival at 5 years New biomarkers for screening of tumour microenvironment Timepoint: 4 to 6 months | — |
Countries
India
Contacts
Public ContactDr Vijayakumar D K
Amrita Institute of Medical Sciences
Outcome results
None listed