Autopsy report · NCT04251533

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

“The study was terminated following a strategic decision to halt recruitment due to persistently slow enrollment. This decision was not driven by any new or unexpected safety concerns.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 5 years 8 months before it stopped.
• 137 participants enrolled.
• Results were posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Triple Negative Breast Neoplasms

Interventions

alpelisib; placebo; nab-paclitaxel

Participants

137

Sites

78

Countries

Argentina, Australia, Austria, Brazil, Bulgaria, China, Colombia, Croatia, France, Germany, Hungary, India and more

Trials that died the same way

• An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
  “Study terminated due to lack of enrollment of the target population. There were no safety, efficacy, or regulatory interaction involved in the decision to stop enrollment.” (86% match in meaning)
• Surgical Treatment of Chronic Neuropathic Pain
  “The study was terminated due to lower than expected enrollment. The decision to terminate the study was not based on any safety or efficacy concerns.” (86% match in meaning)
• Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs
  “Study terminated due to slow enrollment and change in strategy.” (85% match in meaning)
• Evaluation of the Clinical and Economic Impact of painPRIMER in the Treatment of Low Back Pain in a Primary Care Setting
  “The study was terminated on 02-Jun-2014 due to slow enrollment. The study was not terminated for reasons of either safety or efficacy.” (85% match in meaning)
• Acute Effects Of Donepezil On Brain Perfusion And Memory In Subjects With Cognitive Impairment And Mild Alzheimer's Disease
  “The study was terminated because of slow enrollment. The decision to terminate the trial was not based on any safety or efficacy concerns.” (84% 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.