Autopsy report · NCT03786107

HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib

“The study was stopped early due to increased global access to genomic screening. It is no longer economical to continue with this particular single-gene screening protocol.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 months before it started.
• Ran for about 1 year 10 months before it stopped.
• 1,583 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Sponsor

Puma Biotechnology, Inc.

Sponsor type

Industry

Conditions

Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer; Metastatic Cervical Cancer

Interventions

Almac HER-Seq Assay

Participants

1,583

Sites

22

Countries

France, Ireland, Israel, Italy, Serbia, Spain, United States

Trials that died the same way

• Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
  “The study stopped due to marketing approval by the FDA.” (60% match in meaning)
• GeneSearch Breast Lymph Node (BLN) Assay Timing Study
  “GeneSearch™ BLN Assay has been voluntarily withdrawn from the US market.” (59% match in meaning)
• A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
  “FDA reclassified so all 522 studies were stopped,” (59% match in meaning)
• Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
  “US FDA is streamlining the Biosimilar development. Thus, Biocon decided to terminate the study.” (58% match in meaning)
• Assessment of Artificial Intelligence Algorithms for ROTEM
  “The study was stopped because it was considered unlikely that the required number of patients could be prospectively recruited across the participating study centers.” (58% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.