Low-dose immunotherapy in addition to chemotherapy in patients with triple negative breast cancer

An investigator-initiated phase II randomized controlled trial of low-dose pembrolizumab in addition to standard neoadjuvant chemotherapy in patients with triple negative breast cancer - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060529

Enrollment

154

Registered

2023-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Pembrolizumab: Standard chemotherapy with lowdose pembrolizumab 50 mg every 6 weeks. Control Intervention1: Control arm: Standard neoadjuvant chemotherapy 4 cycles of Anthracycline and

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are diagnosed with triple negative breast cancer. 2. Patients who are planned to give NACT.

Exclusion criteria

Exclusion criteria: 1. Patients who are not TNBC. 2. Patients who are not given NACT.

Design outcomes

Primary

Measure	Time frame
To compare pathological complete response with addition of low dose pembrolizumab in addition to NACT in patients with TNBCTimepoint: To compare pathological complete response with addition of low dose pembrolizumab in addition to NACT in patients with TNBC	—

Secondary

Measure	Time frame
1. To compare disease free survival in the two arms. 2. Pharmacokinetics and pharmacodynamics of low dose pembrolizumab. 3. PDL-1 IHC, genomic profile and tumor mutational burdenTimepoint: 5 Years	—

Countries

India

Contacts

Public ContactAtul Batra

All India Institute of Medical Sciences

batraatul85@gmail.com9013078407

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026