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. 2025 Feb 27;26(1):73.
doi: 10.1186/s13063-025-08726-9.

A phase II, randomized, open-labeled study to evaluate low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer (TNBC)

Adhip Arora  1 , V Seenu  2 , Rajinder Parshad  2 , V K Bansal  2 , Anita Dhar  2 , Sandeep Mathur  3 , Pranay Tanwar  4 , Piyush Mishra  2 , Kamal Kataria  2 , Suhani  2 , Ajay Gogia  1 , Brijesh Kumar  2 , K P Haresh  5 , Supriya Mallick  5 , Surendra Kumar Saini  5 , Ashutosh Mishra  6 , Babul Bansal  6 , Jyoti Sharma  6 , Jyoutishman Saikia  6 , Krithika Rangarajan  7 , Ekta Dhamija  7 , Chandra Prakash Prasad  4 , Shamim Ahmed Shamin  8 , Sourabh Agastm  9 , Kaushal Kalra  10 , Divvay Vishvam  10 , Kalaivani Mani  11 , Akash Kumar  1 , Sameer Bakhshi  1 , Atul Batra  12
Affiliations

A phase II, randomized, open-labeled study to evaluate low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer (TNBC)

Adhip Arora et al. Trials. .

Abstract

Background: Breast cancer is the most common malignancy diagnosed in women worldwide. Triple-negative breast cancer (TNBC) is the most aggressive subtype, accounting for nearly one third of all breast cancers in India. The addition of pembrolizumab to neoadjuvant chemotherapy improved the pathological response and event free survival in patients with TNBC. However, for most patients in low- and middle-income countries, immunotherapy remains inaccessible due to its high cost. Pharmacological and early clinical data suggest that a lower dose of pembrolizumab may be effective. However, there are no prospective clinical trials in patients with TNBC.

Methods: This is a single-site phase II, randomized, open-labeled, parallel-group trial. Eligible patients will be randomized (1:1) to either of the two treatment groups. Patients in the control arm will be administered standard of care chemotherapy [4 cycles of dose-dense doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), followed by 4 cycles of dose-dense paclitaxel (175 mg/m2)]. Patients in the experimental arm will receive 3 doses of pembrolizumab 50 mg every 6 weeks along with neoadjuvant dose-dense chemotherapy. The primary objective of the study is to compare the pathological complete response with the addition of low-dose pembrolizumab to neoadjuvant chemotherapy in patients with TNBC. Secondary objectives include invasive disease-free survival and quality of life assessment.

Discussion: The PLANeT trial aims to establish the efficacy of low-dose pembrolizumab in addition to neoadjuvant chemotherapy in patients with triple-negative breast cancer patients. This strategy, if found effective, will help improve the outcomes of women with TNBC who currently have limited access to pembrolizumab.

Trial registration: Clinical Trials Registry of India-CTRI/2024/01/062088.

Keywords: Breast cancer; Immunotherapy; Low dose; Non-metastatic; Pembrolizumab; Triple negative.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate {24}: Trial protocol has been approved by the institute ethics committee for postgraduate research at All India Institute of Medical Sciences; Ref. No.: AIIMSA00540/18.01.2024, RT-39/21.02.2024. Consent for publication {32}: Not applicable. Competing interests {28} The authors declare no competing interests.

References

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