A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
Model scores of the 29,894 trials active now.
Model score 18% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2020-02-06, after 2016-09-26 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2020-02-06. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: metastaticpriorcancerlocally advancedradiation
Phrases that lowered it: participantsand safetyefficacy andsystemicthe efficacy -
Phase: 2 (raises risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Sponsor's past termination rate: 9.1% (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 137 (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 16.3% (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 910 (raises risk) · Sponsor's track record
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Blinding: double (raises risk) · Design
-
Number of arms: 2 (raises risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
-
Responsible party: sponsor (lowers risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 910 (typical: 32)
- Sponsor's past termination rate
- 9.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 137 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 2349 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1179 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 16.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- ado trastuzumab emtansine, atezolizumab, trastuzumab emtansine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor (HER)2 Immunohistochemistry (IHC)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) NCT02289833 · started 2014 · scored riskier than 58% of active trials completed
- A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer NCT04298918 · started 2020 · scored riskier than 78% of active trials terminated
- A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer NCT01966471 · started 2014 · scored riskier than 18% of active trials completed
- A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) NCT04740918 · started 2021 · scored riskier than 53% of active trials terminated
- A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease NCT00679341 · started 2008 · scored riskier than 85% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.