NCT04373031

Induction Immunotherapy to Promote Immunologic Priming and Enhanced Response to Neoadjuvant Pembrolizumab + Chemotherapy in Triple Negative Breast Cancer (TNBC)

Active, enrolled Phase 2 Results posted Last updated 7 April 2026

What this trial tests

Phase 2 trial testing Pembrolizumab in Breast Cancer in 12 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

30 December 2020

Primary endpoint
8 July 2023

1 December 2026

Quick facts

Lead sponsor	Providence Health & Services
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	30 December 2020
Primary completion	8 July 2023
Estimated completion	1 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• IRX 2

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

Providence Health & Services — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)
  Time frame: Following definitive surgery, approximately 9 months.
  Number of patients who showed pCR post surgery. pCR rate (ypT0/Tis ypN0) is defined as the proportion of subjects without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy per the current AJCC staging criteria assessed by the local pathologist at the time of

Sponsor's own description

This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple negative breast cancer (TNBC).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advancements in clinical aspects of targeted therapy and immunotherapy in breast cancer.
   Ye F, Dewanjee S, Li Y, Jha NK, et al · · 2023 · cited 361× · PMID 37415164 · DOI 10.1186/s12943-023-01805-y
2. Pembrolizumab and atezolizumab in triple-negative breast cancer.
   Kwapisz D. · · 2021 · cited 189× · PMID 33015734 · DOI 10.1007/s00262-020-02736-z
3. Immunotherapy for Metastatic Triple Negative Breast Cancer: Current Paradigm and Future Approaches.
   Geurts V, Kok M. · · 2023 · cited 53× · PMID 37079257 · DOI 10.1007/s11864-023-01069-0
4. Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer.
   Sanchez K, Kim I, Chun B, Pucilowska J, et al · · 2021 · cited 44× · PMID 33413574 · DOI 10.1186/s13058-020-01378-4
5. Current and future immunotherapy for breast cancer.
   Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z
6. Immunotherapy for triple-negative breast cancer: A molecular insight into the microenvironment, treatment, and resistance.
   Bai X, Ni J, Beretov J, Graham P, et al · · 2021 · cited 33× · PMID 39036372 · DOI 10.1016/j.jncc.2021.06.001
7. Immune-Based Therapy in Triple-Negative Breast Cancer: From Molecular Biology to Clinical Practice.
   Carlino F, Diana A, Piccolo A, Ventriglia A, et al · · 2022 · cited 26× · PMID 35565233 · DOI 10.3390/cancers14092102
8. Modern Immunotherapy in the Treatment of Triple-Negative Breast Cancer.
   Wesolowski J, Tankiewicz-Kwedlo A, Pawlak D. · · 2022 · cited 20× · PMID 36010854 · DOI 10.3390/cancers14163860