Triple Negative Breast Cancer (TNBC), Early SettingPhase 3PLANETNCT07486687
Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy
A Phase 3 study of Triple Negative Breast Cancer (TNBC), Early Setting and Early Stage Triple-Negative Breast Carcinoma, run by The Netherlands Cancer Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer (TNBC), Early Setting, Early Stage Triple-Negative Breast Carcinoma, Triple -Negative Breast Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2036
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
- The patient underwent breast surgery ≤12 weeks prior to inclusion in the study
Show all 17Show fewer
- 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 >02
- World Health Organization (WHO) performance status 0-2
- Adequate organ function, as assessed ≤30 days prior to the screening:
- Absolute neutrophil count (ANC) ≥1,000/mm3 (1.0 x 10e9 /L)
- Platelets ≥50,000/mm3 (50 x 10e9 /L);
- Estimated creatinine clearance ≥ 30 mL/min as calculated using the method standard for the institution;
- Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert's disease);
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN
- 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
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national/local regulations
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial
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.
- Conditions
- Triple Negative Breast Cancer (TNBC), Early Setting, Early Stage Triple-Negative Breast Carcinoma, Triple -Negative Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III
- Being tested
- Standard of care plus pembrolizumab, Standard of care (capecitabine or olaparib)
- Keywords
- Immunotherapy, Pembrolizumab, Triple negative breast cancer, Breast cancer, TNBC, Adjuvant
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care plus pembrolizumabDrug
Also called KEYTRUDA
Standard of care adjuvant treatment (capecitabine or olaparib) plus pembrolizumab
Standard of care (capecitabine or olaparib)Drug
Also called Xeloda / Lynparza
Standard of care adjuvant treatment (capecitabine or olaparib)
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Patients randomized to the control arm of the trial will receive standard of care adjuvant treatment (capecitabine or, in case of BRCA germline mutation, olaparib (if reimbursed)). Receives: Drug: Standard of care (capecitabine or olaparib) |
| Standard of care plus pembrolizumab | Experimental | Patients randomized to the investigational arm of the trial will receive standard of care adjuvant treatment (capecitabine or, in case of BRCA germline mutation, olaparib (if reimbursed)) plus pembrolizumab. Receives: Drug: Standard of care plus pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 years after inclusion of the last patient
Secondary outcomes (8)
Distant disease free survival (DDFS)
DDFS, defined as time from randomisation to distant recurrence or death due to any cause.
Measured: Up to 10 years after inclusion of the last patient
Overall survival (OS)
OS, defined as time from randomisation to death due to any cause.
Measured: Up to 10 years after inclusion of the last patient
Safety/adverse events of adjuvant pembrolizumab
Measured by adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs).
Measured: Up to 28 days after inclusion of the last patient
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.
Measured: Up to 1 year after inclusion of the last patient
Health related quality of life (HRQoL) - EORTC Quality of Life Questionnaire (QLQ)-BR42
The effect of adjuvant pembrolizumab on health-related quality of life (HRQoL), assessed via Quality of Life Questionnaire (QLQ)-BR42. 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.
Measured: Up to 1 year after inclusion of the last patient
Health related quality of life (HRQoL) - EuroQol Health Utilities Index (EQ-5D)
The effect of adjuvant pembrolizumab on health-related quality of life (HRQoL), assessed via EuroQol Health Utilities Index (EQ-5D). Overall scores range from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health
Measured: Up to 1 year after inclusion of the last patient
Cost-utility measured per incremental cost-effectiveness ratio (ICER)
Cost-utility, based on the incremental cost-effectiveness ratio (ICER).
Measured: Up to 28 days after inclusion of the last patient
Efficacy of pembrolizumab according to tissue biomarkers
Efficacy of pembrolizumab according to tissue biomarkers (including but not limited to stromal tumor infiltrating lymphocytes (sTILs) and programmed death-ligand 1 (PD-L1 expression))
Measured: Up to 10 years after inclusion of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2032 (estimated)
- Study completionApr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast Cancer (TNBC), Early SettingStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- BOOG Study Center, Stichting Treatmeds, Zorgevaluatie en Gepast Gebruik (ZE&GG), Integraal Kankercentrum Nederland (IKNL)
- Responsible party
- Sponsor
- Investigators
- Gabe Sonke, MD, PhD, Principal investigator, Netherlands Cancer Institute - Antoni van LeeuwenhoekMarleen Kok, MD, PhD, Principal investigator, Netherlands Cancer Institute - Antoni van LeeuwenhoekAgnes Jager, MD, PhD, Principal investigator, Erasmus MC Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486687
- Sponsor's protocol ID
- M25PLN
- Other IDs
- 2025-524229-41-00, 2025
- Acronym
- PLANET
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial
- ClinicalTrials.gov ID
- NCT07486687
- Acronym / sponsor ID
- PLANET / M25PLN
- Conditions
- Triple Negative Breast Cancer (TNBC), Early Setting, Early Stage Triple-Negative Breast Carcinoma, Triple -Negative Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III
- Keywords
- Immunotherapy, Pembrolizumab, Triple negative breast cancer, Breast cancer, TNBC, Adjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- BOOG Study Center, Stichting Treatmeds, Zorgevaluatie en Gepast Gebruik (ZE&GG), Integraal Kankercentrum Nederland (IKNL)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2032 (estimated)
- Study completion
- Apr 2036 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: Standard of care (capecitabine or olaparib)Patients randomized to the control arm of the trial will receive standard of care adjuvant treatment (capecitabine or, in case of BRCA germline mutation, olaparib (if reimbursed)). |
| Standard of care plus pembrolizumab | Experimental | Drug: Standard of care plus pembrolizumabPatients randomized to the investigational arm of the trial will receive standard of care adjuvant treatment (capecitabine or, in case of BRCA germline mutation, olaparib (if reimbursed)) plus pembrolizumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
- 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
- The patient underwent breast surgery ≤12 weeks prior to inclusion in the study
- 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 >02
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care plus pembrolizumabAlso: KEYTRUDAStandard of care adjuvant treatment (capecitabine or olaparib) plus pembrolizumab | Drug | Standard of care plus pembrolizumab |
| Standard of care (capecitabine or olaparib)Also: Xeloda / LynparzaStandard of care adjuvant treatment (capecitabine or olaparib) | Drug | Standard of care |
Primary outcome
Invasive disease free survival (IDFS)
Time frame: Up to 10 years after inclusion of the last patient
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.
8 secondary outcomes
Distant disease free survival (DDFS)
Time frame: Up to 10 years after inclusion of the last patient
Overall survival (OS)
Time frame: Up to 10 years after inclusion of the last patient
Safety/adverse events of adjuvant pembrolizumab
Time frame: Up to 28 days after inclusion of the last patient
Health related quality of life (HRQoL) - EORTC Quality of Life Questionnaire (QLQ)-C30
Time frame: Up to 1 year after inclusion of the last patient
Health related quality of life (HRQoL) - EORTC Quality of Life Questionnaire (QLQ)-BR42
Time frame: Up to 1 year after inclusion of the last patient
Health related quality of life (HRQoL) - EuroQol Health Utilities Index (EQ-5D)
Time frame: Up to 1 year after inclusion of the last patient
Cost-utility measured per incremental cost-effectiveness ratio (ICER)
Time frame: Up to 28 days after inclusion of the last patient
Efficacy of pembrolizumab according to tissue biomarkers
Time frame: Up to 10 years after inclusion of the last patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabe Sonke, MD, PhD principal investigator
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Marleen Kok, MD, PhD principal investigator
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Agnes Jager, MD, PhD principal investigator
Erasmus MC Cancer Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Triple Negative Breast Cancer (TNBC), Early Setting and Early Stage Triple-Negative Breast Carcinoma, run by The Netherlands Cancer Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robin van den Borg, MD (+31205129111 ext. 1405, planet@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease free survival (IDFS) (time frame: Up to 10 years after inclusion of the last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.