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Clinical Trial NCT07486687 (PLANET) for 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 is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy (PLANET) Phase 3 1,000 Randomized

Not yet recruiting
Clinical Trial NCT07486687 (PLANET) is designed to study Treatment for 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. This Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 1,000 participants. Led by The Netherlands Cancer Institute, this study is expected to complete by 1 April 2036. The latest data from ClinicalTrials.gov was last updated on 20 March 2026.
Brief 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. All study procedures resemble routine clinical practice as much as possible (i.e., pragmatic clinica...Show More
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

Conditions
Triple Negative Breast Cancer (TNBC), Early SettingEarly Stage Triple-Negative Breast CarcinomaTriple -Negative Breast CancerBreast Cancer Stage IIBreast Cancer Stage III
Other Study IDs
  • PLANET
  • M25PLN
  • 2025-524229-41-00 (EU Study (CTIS) Number)
NCT ID Number
NCT07486687
Start Date (Actual)
2026-04
Last Update Posted
2026-03-20
Completion Date (Estimated)
2036-04
Enrollment (Estimated)
1,000
Study Type
Interventional
PHASE
Phase 3
Status
Not yet recruiting
Keywords
Immunotherapy
Pembrolizumab
Triple negative breast cancer
Breast cancer
TNBC
Adjuvant
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorStandard of care
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 (capecitabine or olaparib)
Standard of care adjuvant treatment (capecitabine or olaparib)
ExperimentalStandard of care plus pembrolizumab
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.
Standard of care plus pembrolizumab
Standard of care adjuvant treatment (capecitabine or olaparib) plus pembrolizumab
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Up to 10 years after inclusion of the last patient
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Distant disease free survival (DDFS)
DDFS, defined as time from randomisation to distant recurrence or death due to any cause.
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.
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).
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.
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.
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
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).
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))
Up to 10 years after inclusion of the last patient
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  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

    1. 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
    2. Locally assessed estrogen receptor (ER) and/or progesterone receptor (PR) expression <10% and HER2-negative according to the ASCO-CAP guideline1

  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 >02

  6. World Health Organization (WHO) performance status 0-2

  7. Adequate organ function, as assessed ≤30 days prior to the screening:

    1. Absolute neutrophil count (ANC) ≥1,000/mm3 (1.0 x 10e9 /L)
    2. Platelets ≥50,000/mm3 (50 x 10e9 /L);
    3. Estimated creatinine clearance ≥ 30 mL/min as calculated using the method standard for the institution;
    4. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert's disease);
    5. 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

  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
The Netherlands Cancer Institute logoThe Netherlands Cancer Institute
  • 🏥BOOG Study Center
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Study Central Contact
Contact: Robin van den Borg, MD, +31205129111, [email protected]
Contact: Annemiek van Ommen-Nijhof, MD, PhD, +31205129111, [email protected]
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