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,
V. Seenu,
Rajinder Parshad,
V. K. Bansal,
Anita Dhar,
Sandeep Mathur,
Pranay Tanwar,
Piyush Mishra,
Kamal Kataria,
Suhani,
Ajay Gogia,
Brijesh Kumar,
K. P. Haresh,
Supriya Mallick,
Surendra Kumar Saini,
Ashutosh Mishra,
Babul Bansal,
Jyoti Sharma,
Jyoutishman Saikia,
Krithika Rangarajan,
Ekta Dhamija,
Chandra Prakash Prasad,
Shamim Ahmed Shamin,
Sourabh Agastm,
Kaushal Kalra,
Divvay Vishvam,
Kalaivani Mani,
Akash Kumar,
Sameer Bakhshi,
Atul Batra
Affiliations
Adhip Arora
Department of Medical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
V. Seenu
Department of Surgical Disciplines, All India Institute of Medical Sciences
Rajinder Parshad
Department of Surgical Disciplines, All India Institute of Medical Sciences
V. K. Bansal
Department of Surgical Disciplines, All India Institute of Medical Sciences
Anita Dhar
Department of Surgical Disciplines, All India Institute of Medical Sciences
Sandeep Mathur
Department of Pathology, All India Institute of Medical Sciences
Pranay Tanwar
Department of Laboratory Oncology, All India Institute of Medical Sciences
Piyush Mishra
Department of Surgical Disciplines, All India Institute of Medical Sciences
Kamal Kataria
Department of Surgical Disciplines, All India Institute of Medical Sciences
Suhani
Department of Surgical Disciplines, All India Institute of Medical Sciences
Ajay Gogia
Department of Medical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Brijesh Kumar
Department of Surgical Disciplines, All India Institute of Medical Sciences
K. P. Haresh
Department of Radiation Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Supriya Mallick
Department of Radiation Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Surendra Kumar Saini
Department of Radiation Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Ashutosh Mishra
Department of Surgical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Babul Bansal
Department of Surgical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Jyoti Sharma
Department of Surgical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Jyoutishman Saikia
Department of Surgical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Krithika Rangarajan
Department of Radio-diagnosis, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Ekta Dhamija
Department of Radio-diagnosis, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Chandra Prakash Prasad
Department of Laboratory Oncology, All India Institute of Medical Sciences
Shamim Ahmed Shamin
Department of Nuclear Medicine, All India Institute of Medical Sciences
Sourabh Agastm
Department of Cardiology, All India Institute of Medical Sciences
Kaushal Kalra
Department of Medical Oncology, VMMC and Safdarjung Hospital
Divvay Vishvam
Department of Medical Oncology, VMMC and Safdarjung Hospital
Kalaivani Mani
Department of Biostatistics, All India Institute of Medical Sciences
Akash Kumar
Department of Medical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Sameer Bakhshi
Department of Medical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
Atul Batra
Department of Medical Oncology, Dr BR Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
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.
