Canadian real-world hybrid longitudinal cohort study of treatment discontinuations and modifications for patients with HER2+ and HER2-low metastatic breast cancer on trastuzumab deruxtecan enrolled in a patient support programme: the HER-TEMPO study protocol
Bibliographic record
Abstract
BACKGROUND: In current clinical practice, breast cancer is treated according to hormone receptor and human epidermal growth receptor 2 expression (HER2) status, which play an important role in disease management and overall prognosis. Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-breast trials. Recent marketing authorisation for T-DXd has been granted from Health Canada for HER2-positive breast cancer who have received prior treatment with trastuzumab emtansine, or at least one prior anti-HER2-based regimen in the metastatic setting, or who have received a prior anti-HER2-based regimen in the neoadjuvant or adjuvant setting and developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy. T-DXd is also indicated for HER2-low unresectable and/or metastatic breast cancer (mBC) patients who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. However, there is a paucity of evidence assessing T-DXd in the real-world setting. As such, the overarching aim of this study is to generate Canadian real-world evidence on discontinuations and treatment modifications for patients with HER2+ and HER2-low mBC undergoing treatment with T-DXd. METHODS AND ANALYSIS: This is a hybrid, longitudinal cohort study design leveraging patient support programme (PSP) secondary data with additional primary data collection to assess study treatment-related outcomes among patients with HER2+ and HER2-low mBC receiving treatment with T-DXd. Mainly, this study will leverage secondary data from the PSP, which will include clinical and demographic characteristics as well as duration, modification and intensity of treatment information for patients while enrolled in the PSP. These data will be supplemented with primary data, which will be collected via a patient questionnaire and include additional self-reported clinical and demographic characteristics not captured within the PSP, including follow-up data on therapies received, treatment discontinuation information after the PSP closure and frequency of CT scans and cardiac monitoring scans. ETHICS AND DISSEMINATION: The study protocol was approved by the Advarra Institutional Review Board on 13 December 2023 (ID: D133HR00037). Findings will be disseminated by publication in peer-reviewed journals, through oral and poster presentations for various audiences, websites and scientific meetings. Written informed consent will be obtained from all patients prior to agreeing to participate in this study. STATUS: Participant recruitment for primary data collection began on 22 April 2024 and was completed on 8 October 2024. Primary data collection for follow-up will continue through up to 12 months after the date of the last enrolment. TRIAL REGISTRATION NUMBER: NCT06386263.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.009 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.004 |
| Science and technology studies | 0.003 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".