The phase III, multicenter, pragmatic PLANET trial aims to evaluate the benefit and safety of pembrolizumab as an addition to standard of care adjuvant treatment (capecitabine or olaparib) in triple negative breast cancer (TNBC) patients with residual disease (non-pCR) after neoadjuvant chemotherapy and pembrolizumab. All study procedures resemble routine clinical practice as much as possible (i.e., pragmatic clinical trial). In addition to the randomized trial, a registry will be set up, in which patients who reach pCR (and therefore, do not receive adjuvant treatment) will be registered and followed.
Male or female, ≥18 years of age on day of signing informed consent
Stage II or III TNBC prior to the start of neoadjuvant treatment
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
Locally assessed estrogen receptor (ER) and/or progesterone receptor (PR) expression <10% and HER2-negative according to the ASCO-CAP guideline1
Contra-indications for any of the study drugs
Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago
The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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
Parallel
Standard of care plus pembrolizumab
DrugStandard of care adjuvant treatment (capecitabine or olaparib) plus pembrolizumab
Standard of care (capecitabine or olaparib)
DrugStandard of care adjuvant treatment (capecitabine or olaparib)
Invasive disease free survival (IDFS)
IDFS, defined as time since randomisation to local or distant breast cancer recurrence, second primary non-breast cancer or death due to any cause, whichever occurs first.
Distant disease free survival (DDFS)
DDFS, defined as time from randomisation to distant recurrence or death due to any cause.
Overall survival (OS)
OS, defined as time from randomisation to death due to any cause.
Safety/adverse events of adjuvant pembrolizumab
Measured by adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs).
Health related quality of life (HRQoL) - EORTC Quality of Life Questionnaire (QLQ)-C30
The effect of adjuvant pembrolizumab on health-related quality of life (HRQoL), assessed via Quality of Life Questionnaire (QLQ)-C30. For functional and global HRQoL scales, higher scores represent a better level of functioning and are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represents more severe symptoms.
Click on the lead sponsor to view all of their trials.
The Netherlands Cancer Institute
Lead sponsor
BOOG Study Center
Collaborator
Stichting Treatmeds
Collaborator
Zorgevaluatie en Gepast Gebruik (ZE&GG)
Collaborator
Integraal Kankercentrum Nederland (IKNL)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
