Comparison · NCT03620643-97864aa5
Crizotinib Oral Capsule [Xalkori] Monotherapy vs Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Crizotinib Oral Capsule [Xalkori] Monotherapy vs Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs). Trial comparisons, record NCT03620643-97864aa5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03620643-97864aa5
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.61 | 1 | wilson | |
| Risk in group 2 | 1 | 0.875 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.39 | 0.125 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Crizotinib Oral Capsule [Xalkori] Monotherapy | Arm 1 - Basket (diffuse gastric cancer, triple negative lobular breast cancer and Other CDH1 mutated cancer) cohort. | 6 | 6 | OG000 |
| Group 2 | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | Arm 2 - ER positive lobular breast cancer cohort | 27 | 27 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
- Description
To assess the overall safety and tolerability of crizotinib with fulvestrant in the breast cancer cohort and as monotherapy in the basket cancer cohort. Toxicity will be assessed by CTCAE (version 4) every 4 weeks during study treatment. Adverse events, including serious adverse events, will be recorded until 30 days after the last dose of study treatment with crizotinib.
- Time frame
- From Day 1 to 30 days after last dose of study drug, assessed up to end of study (Approximately 57 months)
- Population
- Intention to treat (ITT) analysis population.
Source ClinicalTrials.gov
Trial
- Title
- Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours
- NCT number
- NCT03620643
- Phases
- PHASE2
- Conditions
- Lobular Breast Carcinoma, Gastric Cancer, Triple Negative Breast Cancer, CDH1 Gene Mutation
- Interventions
- Crizotinib Oral Capsule [Xalkori], Fulvestrant 50 MG/ML Prefilled Syringe [Faslodex or generic]
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Results first posted
- 2025-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03620643?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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