Trials / Not Yet Recruiting
Not Yet RecruitingNCT07486687
Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy
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
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,000 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Standard of care plus pembrolizumab | Standard of care adjuvant treatment (capecitabine or olaparib) plus pembrolizumab |
| DRUG | Standard of care (capecitabine or olaparib) | Standard of care adjuvant treatment (capecitabine or olaparib) |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2032-04-01
- Completion
- 2036-04-01
- First posted
- 2026-03-20
- Last updated
- 2026-03-20
Source: ClinicalTrials.gov record NCT07486687. Inclusion in this directory is not an endorsement.