Trial · NCT07486687
Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy
NCT07486687, Phase 3, Not yet recruiting, The Netherlands Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy. Trials, record NCT07486687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07486687
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy
- NCT number
- NCT07486687
- Status
- Not yet recruiting
- Phases
- Phase 3
- Enrollment
- 1,000 participants, estimated
- Lead sponsor
- The Netherlands Cancer Institute
- 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
- Interventions
- Standard of care plus pembrolizumab, Standard of care (capecitabine or olaparib)
- First posted
- 2026-03-20
- Last updated
- 2026-03-20
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive disease free survival (IDFS) | 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. |
| Secondary | Distant disease free survival (DDFS) | Up to 10 years after inclusion of the last patient | DDFS, defined as time from randomisation to distant recurrence or death due to any cause. |
| Secondary | Overall survival (OS) | Up to 10 years after inclusion of the last patient | OS, defined as time from randomisation to death due to any cause. |
| Secondary | Safety/adverse events of adjuvant pembrolizumab | Up to 28 days after inclusion of the last patient | Measured by adverse events (AEs), adverse events of special interest (AESIs) and serious adverse events (SAEs). |
| Secondary | Health related quality of life (HRQoL) - EORTC Quality of Life Questionnaire (QLQ)-C30 | Up to 1 year after inclusion of the last patient | 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. |
| Secondary | Health related quality of life (HRQoL) - EORTC Quality of Life Questionnaire (QLQ)-BR42 | Up to 1 year after inclusion of the last patient | 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. |
| Secondary | Health related quality of life (HRQoL) - EuroQol Health Utilities Index (EQ-5D) | Up to 1 year after inclusion of the last patient | 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 |
| Secondary | Cost-utility measured per incremental cost-effectiveness ratio (ICER) | Up to 28 days after inclusion of the last patient | Cost-utility, based on the incremental cost-effectiveness ratio (ICER). |
| Secondary | Efficacy of pembrolizumab according to tissue biomarkers | Up to 10 years after inclusion of the last patient | 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)) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07486687
GET https://conductscience.org/api/trials/v1/NCT07486687/registered