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Roll of Innate Immune Receptors (TLR) and their agonists in improving chemotherapy response in Triple Negative Breast Cancer Patients.

Roll of toll-like receptors and TLR agonists in modulating response to chemotherapy in TNBC patients.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/03/023958
Enrollment
60
Registered
2020-03-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z191- Hormone sensitive malignancy status

Interventions

Intervention1: NIL: NIL Intervention2: Surgery: Blood samples (at TP01, 02 and 03), breast tumor biopsy sample and adjacent breast normal tissue (at the time of surgery) will be collected at from two

Sponsors

Department of Biotechnology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient Selection: Inclusion criteria: a)Histopathologically proven TNBC b)Age >18 years c)Non-metastatic d)No prior surgery or treatment for breast cancer or any other non-skin cancer e)Undergoing surgery first f)Planned for NACT fit to receive chemotherapy (Normal RFT LFT Hematological parameters 2D ECHO) g)ECOG 0to1 h)Written, informed consent Inclusion criteria for healthy female controls: a)Age >18 years b)Non-pregnant, non-lactating c)No current or past or family history of malignancy d)No h/o autoimmune disorder e)Malignancy screen negative (oral, clinical breast and per vaginal examination SOS mammography, Visual Inspection with Acetic Acid (VIA) or PAP smear negative in last 3 yrs) f)Written, informed consent

Exclusion criteria

Exclusion criteria: Exclusion Criteria: a)Pregnant, lactating b)Previous treatment for breast cancer or any other non-skin cancer c)h/o autoimmune disorder d)Viral markers (HBsAg, HCV, HIV) positive

Design outcomes

Primary

MeasureTime frame
The study is expected to establish the relationship of both soluble and membrane TLR expression with chemotherapy response. Time Point 0 to 24 months Role of epigenetic modifications in TLR genes in TNBC Time Point 24 to 36 months The study will provide evidence for therapeutic efficacy of combining TLR agonists with systemic chemotherapy in Indian TNBC patients Time Point 0 to 16 months Timepoint: Time Point 0 to 24 months Time Point 24 to 36 months Time Point 0 to 16 months—

Secondary

MeasureTime frame
Relevance of innate immune activators such as TLR in predicting chemotherapy response and disease prognosis in TNBC patients.Timepoint: Time Point:12-36 months—

Countries

India

Contacts

Public ContactDr Shalaka Prakash Joshi

ICMR National Institute For Research In Reproductive Health

nupurmukherjee10@gmail.com9748586265

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026