Autopsy report · NCT04675827

De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade

“Serious concerns on the slow recruitment of the study that impacts the robustness of the scientific rationale and the study financial provision. It aims to assess carefully the situation and to evaluate the potential solutions to overcome the issues.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 year 2 months before it started.
• Ran for about 2 years 10 months before it stopped.
• 139 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Jules Bordet Institute

Sponsor type

University, hospital or other

Conditions

HER2-positive Breast Cancer; ER-Negative Breast Cancer; PR-Negative Breast Cancer; Node-negative Breast Cancer

Interventions

Pertuzumab and tratuzumab fixed dose combination; Trastuzumab emtansine

Participants

139

Sites

85

Countries

Australia, Belgium, France, Israel, South Korea, Switzerland

Trials that died the same way

• Calcium, Vitamin D and Metformin to Treat Insulin Resistance in Obese African American Adolescent Females
  “Poor recruitment to the study” (63% match in meaning)
• Safety and Efficacy of the Fruit-based Product OPAL A for the Treatment of Chronic Venous and Pressure Ulcers
  “Slow recruitment caused rethink on the study design” (62% match in meaning)
• A Study of VPRIV in Participants With Gaucher Disease Previously Treated With Other Enzyme Replacement Therapies or Substrate Reduction Therapies
  “The decision was taken after careful consideration relating to recruitment challenges that could impact the scientific value of the study.” (62% match in meaning)
• SMS-based Lifestyle Intervention for Patients With Liver Cirrhosis With Previous Hepathic Encephalopathy
  “Slow recruitment of study participants” (61% match in meaning)
• Exercise Therapy for Asthma (ETA Trial)
  “Study proved difficult to recruit” (59% 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.