Autopsy report · NCT01512199

Phase 1b/2 Study of U3-1287 in Combination With Trastuzumab Plus Paclitaxel in Newly Diagnosed Metastatic Breast Cancer (MBC)

“Improved, different standard of care caused business decision to terminate”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months after it had already started.
• Ran for about 3 years 2 months before it stopped.
• 29 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Daiichi Sankyo

Sponsor type

Industry

Conditions

Metastatic Breast Cancer

Interventions

U3-1287; Trastuzumab; Paclitaxel; U3-1287; Trastuzumab; Paclitaxel

Participants

29

Sites

8

Countries

Argentina, Chile

Trials that died the same way

• Efficacy and Safety of Emapalumab and Anakinra in Reducing Hyperinflammation and Respiratory Distress in Patients With COVID-19 Infection.
  “Standard of care evolved during the timeframe of the study and had critical impact on recruitment. Early termination was not based on safety reasons but due to the reasons mentoined above. The ongoing patients were completed.” (64% match in meaning)
• Real World, Pharmacy-assessed Adherence to New Onset Entresto® (Sacubitril/Valsartan) in Patients With Chronic Heart Failure
  “Terminated due to business decision” (62% match in meaning)
• A Study to Evaluate the Efficacy and Safety of Abiprubart in Participants With Sjögren's Disease
  “Terminated due to strategic business decision.” (61% match in meaning)
• Digoxin for Patients With Non-alcoholic Steatohepatitis (NASH)
  “Administrative decision to terminate.” (60% match in meaning)
• A Study of TAK-102 in Adult With Previously-Treated Solid Tumors
  “Business decision unrelated to patient safety” (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.