Trial · NCT03620643
Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours
NCT03620643, Phase 2, Completed, Royal Marsden NHS Foundation Trust; results first posted 2025-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours. Trials, record NCT03620643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03620643
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours
- NCT number
- NCT03620643
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- 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]
- First posted
- 2018-08-08
- Last updated
- 2025-10-30
- Results first posted
- 2025-10-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Breast Cancer Cohort Participants With Confirmed Response Assessed Using RECIST v1.1 | From Day 1 to Progressive Disease, assessed up to end of study (Approximately 57 months) | To assess confirmed response rate by RECIST 1.1 of crizotinib and fulvestrant in advanced E-cadherin negative, ER positive lobular breast cancer. |
| Primary | Percentage of Basket Cohort Participants With Confirmed Response Assessed Using RECIST v1.1 | From Day 1 to Progressive Disease, assessed up to end of study (Approximately 57 months) | To assess confirmed response rate (CR/PR outcome) by RECIST 1.1 scan of crizotinib monotherapy in advanced E-cadherin negative, diffuse gastric cancer, triple negative lobular breast cancer or CDH1-mutated solid tumour. |
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | From Day 1 to 30 days after last dose of study drug, assessed up to end of study (Approximately 57 months) | 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. |
| Secondary | Progression-free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Both Basket and Breast Cancer Cohorts | From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (Approximately 57 months) | PFS is defined as the time from baseline treatment to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. |
| Secondary | Assessment of Overall Survival in Each Cohort | From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (Approximately 57 months) | Overall survival, calculated from day 1 of study treatment to the date of death from any cause. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Breast Cancer Cohort Participants With Confirmed Response Assessed Using RECIST v1.1 | From Day 1 to Progressive Disease, assessed up to end of study (Approximately 57 months) | Patients who receive at least one cycle of the trial medication and had at least one response (RECIST 1.1 scan) post treatment start. Patients who stopped study treatment before the first response evaluation scan has been performed with clinical progression were included in the disease progression category. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Basket Cohort Participants With Confirmed Response Assessed Using RECIST v1.1 | From Day 1 to Progressive Disease, assessed up to end of study (Approximately 57 months) | Patients who received at least one cycle of the trial medication and had at least one response (RECIST 1.1 scan) post treatment start. Patients who stopped study treatment before the first response evaluation scan has been performed with clinical progression were included in the disease progression category. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | From Day 1 to 30 days after last dose of study drug, assessed up to end of study (Approximately 57 months) | Intention to treat (ITT) analysis population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Both Basket and Breast Cancer Cohorts | From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (Approximately 57 months) | Intention to treat (ITT) analysis population. | months | MEDIAN |
| SECONDARY | Assessment of Overall Survival in Each Cohort | From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (Approximately 57 months) | months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Breast Cancer Cohort Participants With Confirmed Response Assessed Using RECIST v1.1 | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 1 | Participants | ||
| Percentage of Basket Cohort Participants With Confirmed Response Assessed Using RECIST v1.1 | Crizotinib Oral Capsule [Xalkori] Monotherapy | 0 | Participants | ||
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Crizotinib Oral Capsule [Xalkori] Monotherapy | 6 | Participants | ||
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 27 | Participants | ||
| Progression-free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Both Basket and Breast Cancer Cohorts | Crizotinib Oral Capsule [Xalkori] Monotherapy | 1.8 | 95% Confidence Interval 0.5 to NA | months | |
| Progression-free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Both Basket and Breast Cancer Cohorts | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 1.8 | 95% Confidence Interval 1.1 to 3.2 | months | |
| Assessment of Overall Survival in Each Cohort | Crizotinib Oral Capsule [Xalkori] Monotherapy | 4.4 | 95% Confidence Interval 1.3 to NA | months | |
| Assessment of Overall Survival in Each Cohort | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 17.5 | 95% Confidence Interval 6.9 to 26.0 | months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Crizotinib Oral Capsule [Xalkori] Monotherapy | 6 | |
| Overall Study | STARTED | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 27 | |
| Overall Study | COMPLETED | Crizotinib Oral Capsule [Xalkori] Monotherapy | 6 | |
| Overall Study | COMPLETED | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 27 | |
| Overall Study | NOT COMPLETED | Crizotinib Oral Capsule [Xalkori] Monotherapy | 0 | |
| Overall Study | NOT COMPLETED | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 0 |
Source ClinicalTrials.gov
Adverse events146
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Crizotinib Oral Capsule [Xalkori] Monotherapy | 4 | 6 | |
| other | Alanine aminotransferase increased | Investigations | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 17 | 27 | |
| other | Aspartate aminotransferase increased | Investigations | Crizotinib Oral Capsule [Xalkori] Monotherapy | 4 | 6 | |
| other | Aspartate aminotransferase increased | Investigations | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 20 | 27 | |
| other | Abdominal pain | Gastrointestinal disorders | Crizotinib Oral Capsule [Xalkori] Monotherapy | 2 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 8 | 27 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Crizotinib Oral Capsule [Xalkori] Monotherapy | 3 | 6 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 2 | 27 | |
| other | Constipation | Gastrointestinal disorders | Crizotinib Oral Capsule [Xalkori] Monotherapy | 2 | 6 | |
| other | Constipation | Gastrointestinal disorders | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 10 | 27 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Crizotinib Oral Capsule [Xalkori] Monotherapy | 6 | 6 |
| Total, all-cause mortality | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 20 | 27 |
| Total, other adverse events | Crizotinib Oral Capsule [Xalkori] Monotherapy | 6 | 6 |
| Total, other adverse events | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 27 | 27 |
| Total, serious adverse events | Crizotinib Oral Capsule [Xalkori] Monotherapy | 4 | 6 |
| Total, serious adverse events | Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection | 5 | 27 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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 |
| Crizotinib Oral Capsule [Xalkori] Monotherapy vs Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection: deaths from any cause | Trial comparisons |
| Crizotinib Oral Capsule [Xalkori] Monotherapy vs Crizotinib Oral Capsule [Xalkori] Plus Fulvestrant Injection: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03620643
GET https://conductscience.org/api/trials/v1/NCT03620643/events?page=2