A RANDOMIZED PHASE 3 DOUBLE-BLINDED STUDY COMPARING THE EFFICACY AND SAFETY OF NIRAPARIB TO PLACEBO IN PARTICIPANTS WITH EITHER HER2-NEGATIVE BRCA-MUTATED OR TRIPLE-NEGATIVE BREAST CANCER WITH MOLECULAR DISEASE BASED ON PRESENCE OF CIRCULATING TUMOR DNA AFTER DEFINITIVE THERAPY (ZEST)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504454-35-00

Acronym

213831

Enrollment

143

Registered

2024-08-05

Start date

2021-06-22

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast, Neoplasms

Brief summary

"Primary End Point - The incidence of TEAEs, SAEs, and AESIs; TEAEs leading to death, TEAEs leading to dose modifications, and TEAEs leading to discontinuation will be assessed. Clinically relevant laboratory parameters, vital signs, ECOG performance status, and use of concomitant medications will be collected and evaluated as defined in the Statistical Analysis Plan (SAP)"

Interventions

DRUGNiraparib Placebo Tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
"Primary End Point - The incidence of TEAEs, SAEs, and AESIs; TEAEs leading to death, TEAEs leading to dose modifications, and TEAEs leading to discontinuation will be assessed. Clinically relevant laboratory parameters, vital signs, ECOG performance status, and use of concomitant medications will be collected and evaluated as defined in the Statistical Analysis Plan (SAP)"	—

Countries

Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026