Adjuvant Pembrolizumab in patients with early-stage triple negative breast cancer with residual disease after treatment with chemotherapy and pembrolizumab

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Zorgevaluatie en Gepast Gebruik (ZE&GG) · Stichting Treatmeds

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To evaluate the benefit of pembrolizumab as an addition to standard of care adjuvant treatment (capecitabine or olaparib) (pending reimbursement) in TNBC patients with residual disease after neoadjuvant chemotherapy and pembrolizumab.

Secondary objectives 5

1. To evaluate the value of adjuvant pembrolizumab in specific subgroups (according to residual cancer burden (RCB) and BRCA germline status)
2. To evaluate the safety of adjuvant pembrolizumab
3. To evaluate the effect of adjuvant pembrolizumab on health-related quality of life (HRQoL)
4. To evaluate cost-utility of adjuvant pembrolizumab
5. To set up a registry for all patients with stage II-III TNBC who are intended to start neoadjuvant chemotherapy in combination with pembrolizumab (PLANET-registry)

Conditions and MedDRA coding

Triple negative breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Male or female, ≥18 years of age on day of signing informed consent
2. Stage II or III TNBC prior to the start of neoadjuvant treatment: a) Locally assessed stage II or III TNBC according to the primary tumor (T) and regional lymph node (N) staging as per the American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8; b) Locally assessed estrogen receptor (ER) and/or progesterone receptor (PR) expression <10% and HER2-negative according to the ASCO-CAP guideline
3. The patient has received neoadjuvant treatment with chemotherapy (containing at least anthracyclines and taxanes) and pembrolizumab, with a minimum of two 6-weekly (or four 3-weekly) cycles of pembrolizumab
4. The patient underwent breast surgery ≤12 weeks prior to inclusion in the study
5. The patient is scheduled to start standard of care adjuvant treatment with capecitabine or olaparib (pending reimbursement), based on non-pCR after neoadjuvant treatment, defined as RCB score >0
6. World Health Organization (WHO) performance status 0-2
7. Adequate organ function, as assessed ≤30 days prior to the screening: a) Absolute neutrophil count (ANC) ≥1,000/mm3 (1.0 x 10e9 /L); b) Platelets ≥50,000/mm3 (50 x 10e9 /L); c) Estimated creatinine clearance ≥ 30 mL/min as calculated using the method standard for the institution; d) Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert’s disease); e) Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN
8. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication
9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
10. Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national/local regulations

Exclusion criteria 4

1. Contra-indications for any of the study drugs
2. Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago
3. The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
4. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Invasive disease-free survival (IDFS)

Secondary endpoints 6

1. Distant disease-free survival (DDFS)
2. Overall survival (OS)
3. Safety/adverse events
4. Global health/QoL and physical functioning (assessed via EQ-5D, EORTC QLQ C30 and EORTC QLQ-BR42)
5. Cost-effectiveness
6. IDFS, DDFS and OS in the PLANET registry

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Sponsor organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Gabe Sonke

Public contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Annemiek van Ommen-Nijhof

Locations

1 EU/EEA country · 61 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications