Autopsy report · NCT06038539

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.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 4 months before it started.
• Ran for about 1 year before it stopped.
• 55 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Biocon Biologics UK Ltd

Sponsor type

Industry

Conditions

HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients

Interventions

PERT-IJS plus trastuzumab, carboplatin and docetaxel; Perjeta plus trastuzumab, carboplatin and docetaxel

Participants

55

Sites

1

Countries

India

Trials that died the same way

• Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma
  “The sponsor decided to terminate the study due to financial issues following an FDA request for a partial clinical hold.” (71% match in meaning)
• Continued Access Study of Adefovir Dipivoxil (ADV) for Patients w/Chronic HBV Infection.
  “The study stopped due to marketing approval by the FDA.” (71% match in meaning)
• A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pefcalcitol Ointment, 0.005%, Applied Topically Twice Daily (BID) for 8 Weeks in Adolescent Subjects 12 to < 17 Years of Age With Plaque Psoriasis
  “FDA requested us to stop the study” (71% match in meaning)
• A Study of BMN 255 in Participants With Non-Alcoholic Fatty Liver Disease And Hyperoxaluria
  “The study was withdrawn because BioMarin decided to end the overall development program. The study withdrawal was not due to any patient safety concerns.” (70% match in meaning)
• Panobinostat/Velcade in Multiple Myeloma
  “This study was terminated because the drug company stopped making the study drug” (69% 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.