Studieoverzicht - 2021-02 ZEST

 
Number 2021-02 ZEST
Nickname ZEST
Status Open Date: 31-07-2021
Inclusion closed
Other study number(s) 213831
Participating parties/groups GlaxoSmithKline
Full title 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
Phase and type Other
Age ≥ 18 years
Menopausal status Both pre- and postmenopausal
Indication Adjuvant
Subindication HER2-, any HR
Target sample size 800 (global)
Actual accrual 0 (8 in pre-screening) Date: 30-09-2021
Estimated study completion date 01-05-2029
CCMO approval Yes Date: 21-04-2021 Nr:
EudraCT nr.
Trial Register
METC approval Yes Date: 01-07-2021 METC: Nr:
Amendments No Date: 27-09-2021
KWF-CKS approval Date: 27-09-2021 Nr:
News item
Website
Sponsor GlaxoSmithKline
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 Contact: Natascha.x.verra@GSK.com

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  :

  1. Disease-free survival (DFS) [ Time Frame: Up to 4 years ]

 

Secondary Outcome Measures  :

  1. Overall survival (OS) [ Time Frame: Up to 8 years ]
  2. Time to progression on next anticancer therapy (TTP) [ Time Frame: Up to 8 years ]
  3. Distant recurrence-free survival (DRFS) [ Time Frame: Up to 4 years ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 Alkmaar

Haga ziekenhuis

Isala ziekenhuis 

 

Documents (protected):
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