Studieoverzicht - 2021-02 ZEST
Principal Investigator(s) | ||||
Study manager | Dr. A.E. van Leeuwen-Stok (BOOG Study Center) | |||
Central datamanagement and randomization | GlaxoSmithKline | |||
Monitoring | GlaxoSmithKline | |||
Local datamanagement | ||||
Funding | GlaxoSmithKline | |||
Extra |
Design:
A Randomized multicenter, double-blinded, placebo-controlled phase 3 study
Objectives:
Evaluation of the efficacy of niraparib relative to placebo as measured by progression-free survival (PFS)
Endpoints:
Primary Outcome Measures :
- Disease-free survival (DFS) [ Time Frame: Up to 4 years ]
Secondary Outcome Measures :
- Overall survival (OS) [ Time Frame: Up to 8 years ]
- Time to progression on next anticancer therapy (TTP) [ Time Frame: Up to 8 years ]
- Distant recurrence-free survival (DRFS) [ Time Frame: Up to 4 years ]
- Number of participants with Treatment-emergent adverse events (TEAEs), Serious adverse events (SAEs), TEAEs leading to death, and AEs leading to discontinuation [ Time Frame: Up to 8 years ]
- Number of participants with clinically significant changes in laboratory parameters, vital signs, Eastern Cooperative Oncology Group (ECOG) status, physical examination and use of concomitant medications [ Time Frame: Up to 8 years ]
- Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) (Scores on a scale) [ Time Frame: Baseline (Day 1) and up to 8 years ]
- Change from Baseline in the Functional Assessment of Cancer Therapy - General Population(FACT-GP5) (Scores on a scale) [ Time Frame: Baseline (Day 1) and up to 8 years ]
- Patient reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (Scores on a scale) [ Time Frame: Up to 8 years ]
Main eligibility criteria:
Inclusion Criteria:
- Stage I to III breast cancer with surgical resection of the primary tumor that is confirmed to be either: TNBC, irrespective of BRCA status or HR+/HER2- breast cancer with a known and documented tBRCA mutation.
- Completed prior standard therapy for curative intent including all of the following, if indicated: neoadjuvant treatment, surgery, adjuvant radiotherapy, and adjuvant chemotherapy.
- Participants with HR+ breast cancer must be on a stable regimen of endocrine therapy, if indicated, for at least 3 months prior to enrollment. Ovarian suppression, if indicated, must also have been started at least 3 months prior to enrollment.
- Detectable ctDNA as measured by central Signatera testing.
- An archival tumor tissue specimen of the primary tumor sufficient in quality and quantity for ctDNA assay design and tBRCA and Homologous recombination deficiency (HRD).
Exclusion Criteria:
- Prior treatment with a Poly Adenosine-diphosphate Ribose Polymerase (PARP) inhibitor.
- Current treatment with a Cyclin-dependent kinase (CDK)4/6 inhibitor or endocrine therapy other than anastrozole, letrozole, exemestane, and tamoxifen.
- Participants have any sign of metastasis or local recurrence after comprehensive assessment conducted per protocol.
- Participants have shown no definitive response to preoperative chemotherapy by pathologic or radiographic evaluation, in cases where preoperative chemotherapy was administered.
Documents (public):
Deelnemende centra:
Maastricht UMC+
Medisch Centrum Leeuwarden
Ikazia ziekenhuis
Noordwest Ziekenhuisgroep
Haga ziekenhuis
Isala ziekenhuis
Infographic voor patiënten (download link)
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