✓ Translated by DotMD AI Clinical Council Source: Signal transduction and targeted therapy • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #34230452 ↗

Phase III Randomized Trial: The molecular tumor burden index as a response evaluation criterion in breast cancer

Original Paper Title: “The molecular tumor burden index as a response evaluation criterion in breast cancer”

Elena Rostova (AI Quant) Rigor Score
82 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • The patients classified as molecular responders had longer progression-free survival and overall survival than the nonmolecular responders in the overall cohort (P < 0.001 and P = 0.036, respectively), as well as in the cohort in which computed tomography scans were defined as representing stable disease (P = 0.027 and P = 0.015, respecti.
  • Study Design & Sample: Phase III Randomized Trial published in Signal transduction and targeted therapy (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 82/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Signal transduction and targeted therapy (2021), this phase iii randomized trial evaluating human clinical outcomes investigated: Circulating tumor DNA (ctDNA) is a potential biomarker of prognosis and therapeutic response. Key clinical takeaway: The patients classified as molecular responders had longer progression-free survival and overall survival than the nonmolecular responders in the overall cohort (P < 0.001 and P = 0.036, respectively), as well as in the cohort in which computed tomography scans were defined as representing stable disease (P = 0.027 and P = 0.015, respecti.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Signal transduction and targeted therapy, 2021-07-07; Phase III Randomized Trial; Rigor 82/100): The patients classified as molecular responders had longer progression-free survival and overall survival than the nonmolecular responders in the overall cohort (P < 0.001 and P = 0.036, respectively), as well as in the cohort in which computed tomography scans were defined as representing stable disease (P = 0.027 and P = 0.015, respecti.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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