Pembrolizumab Low dose in Addition to NACT in TNBC

A phase- II randomised open labelled study to evaluate low dose pembrolizumab plus chemotherapy versus chemotherapy as neoadjuvant therapy for localised triple negative breast cancer(TNBC) - PLANeT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/062088

Enrollment

204

Registered

2024-01-30

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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: Low dose Pembrolizumab: Low dose Pembrolizumab (50mg 6 weekly- 3 cycles0 will be given in addition to Standard of Care chemotherapy. Control Intervention1: Standard of Care chemotherapy

Eligibility

Inclusion criteria

Inclusion criteria: 18 years or more age confirmed TNBC ECOG PS 0 or 1 LVEF more than or equal to 50 %

Exclusion criteria

Exclusion criteria: ECOG PS more than 2 autoimmune condition transplant recipient history of invasive malignancy recieved prior Anti PD 1, anti PDL 1 or anti PDL 2 therapy Recieved live vaccine within 30 days

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: 18 weeks.	—

Secondary

Measure	Time frame
To compare radiological response with mammograms performed at baseline & at completion of NACTTimepoint: Baseline & 16 weeks.;To estimate the cost-effectiveness of addition of low-dose pembrolizumab along with chemotherapy from an Indian perspectiveTimepoint: NA;Quality of life assessmentTimepoint: Baseline, 16 weeks.	—

Countries

India

Contacts

Public ContactDr Adhip Arora

Dr. B. R. Ambedkar, Institute Rotary Cancer Hospital

batraatul85@gmail.com919013078407

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 29, 2026