Trial · NCT02429427
European Celecoxib Trial in Primary Breast Cancer
NCT02429427, Phase 3, Completed, Imperial College London; results first posted 2020-06-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. European Celecoxib Trial in Primary Breast Cancer. Trials, record NCT02429427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02429427
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- European Celecoxib Trial in Primary Breast Cancer
- NCT number
- NCT02429427
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,639 participants, actual
- Lead sponsor
- Imperial College London
- Conditions
- Breast Cancer
- Interventions
- Celecoxib, Placebo
- First posted
- 2015-04-29
- Last updated
- 2020-06-23
- Results first posted
- 2020-06-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. | Patients will be followed up to 10 years. DFS will be calculated from date of randomization until the date of first documented DFS event, this will be assessed at 2 and 5 years | From time of randomisation to the date of first event; with events contributing to the analysis defined as loco-regional and distant breast cancer recurrence, new primary breast cancer (ipsilateral or contralateral) and death without disease relapse (intercurrent death) |
| Secondary | Overall Survival | Date of randomisation until the date of death from any cause or censored at the date the patient was last seen alive, this will be assessed at 2 and 5 years | First local recurrence and first distant recurrence will be recorded on separate parts of the CRF. In the event of local progression, all patients must be followed up for distant recurrence, second malignancy and survival. Similarly in the case of second malignancy, the appropriate CRF should be completed and patients should REACT Protocol, Version 39, dated 01.11.2016 Page 34 of 48 continue to be followed for disease progression and where possible the relation of any subsequent disease progression and/or death due to the primary or second cancer should be established. |
| Secondary | Number of Participants With Incidence of Second Primary Breast Cancers | From randomisation until a second primary breast cancer is diagnosed. Patients will be followed up to 10 years. | Any malignant contralateral breast disease will be included and recorded as a second primary |
| Secondary | Cardiovascular Mortality | Patients are followed up to 10 years, any deaths within this timeframe with cardiovascular involvement reported are included in the analysis. | Number of deaths recorded as having cardiovascular involvement are reported by treatment group. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. | Patients will be followed up to 10 years. DFS will be calculated from date of randomization until the date of first documented DFS event, this will be assessed at 2 and 5 years | Intention To Treat: This population includes all patients entered into the study in the treatment group they were allocated to regardless of whether they do not start treatment, take the wrong treatment or deviate in any way from the protocol. | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival | Date of randomisation until the date of death from any cause or censored at the date the patient was last seen alive, this will be assessed at 2 and 5 years | Intention To Treat: This population includes all patients entered into the study in the treatment group they were allocated to regardless of whether they do not start treatment, take the wrong treatment or deviate in any way from the protocol. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Incidence of Second Primary Breast Cancers | From randomisation until a second primary breast cancer is diagnosed. Patients will be followed up to 10 years. | Intention To Treat: This population includes all patients entered into the study in the treatment group they were allocated to regardless of whether they do not start treatment, take the wrong treatment or deviate in any way from the protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Cardiovascular Mortality | Patients are followed up to 10 years, any deaths within this timeframe with cardiovascular involvement reported are included in the analysis. | Safety population: This population includes all patients who start treatment, patients will be analysed by the treatment they received regardless of the group they were allocated to. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. | Celecoxib | 2 Year DFS rate | 91 | 95% Confidence Interval 90 to 93 | Percentage of participants |
| Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. | Placebo | 2 Year DFS rate | 90 | 95% Confidence Interval 87 to 92 | Percentage of participants |
| Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. | Celecoxib | 5 Year DFS rate | 84 | 95% Confidence Interval 82 to 86 | Percentage of participants |
| Disease Free Survival (DFS) Benefit of Two Years Adjuvant Therapy With the COX-2 Inhibitor Celecoxib Compared With Placebo in Primary Breast Cancer Patients. | Placebo | 5 Year DFS rate | 83 | 95% Confidence Interval 81 to 86 | Percentage of participants |
| Overall Survival | Celecoxib | 2 Year | 97 | 95% Confidence Interval 96 to 97 | Percentage of participants |
| Overall Survival | Placebo | 2 Year | 96 | 95% Confidence Interval 95 to 97 | Percentage of participants |
| Overall Survival | Celecoxib | 5 Year | 90 | 95% Confidence Interval 89 to 92 | Percentage of participants |
| Overall Survival | Placebo | 5 Year | 91 | 95% Confidence Interval 88 to 92 | Percentage of participants |
| Number of Participants With Incidence of Second Primary Breast Cancers | Celecoxib | 19 | Participants | ||
| Number of Participants With Incidence of Second Primary Breast Cancers | Placebo | 12 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Celecoxib | 1,763 | |
| Overall Study | STARTED | Placebo | 876 | |
| Overall Study | COMPLETED | Celecoxib | 1,392 | |
| Overall Study | COMPLETED | Placebo | 697 | |
| Overall Study | NOT COMPLETED | Celecoxib | 371 | |
| Overall Study | NOT COMPLETED | Placebo | 179 |
Source ClinicalTrials.gov
Adverse events320
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Celecoxib | 128 | 1,755 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 85 | 868 | |
| other | Hot flush | Reproductive system and breast disorders | Celecoxib | 106 | 1,755 | |
| other | Hot flush | Reproductive system and breast disorders | Placebo | 54 | 868 | |
| other | Hypertension | Vascular disorders | Celecoxib | 178 | 1,755 | |
| other | Hypertension | Vascular disorders | Placebo | 72 | 868 | |
| serious | Anaemia | Blood and lymphatic system disorders | Celecoxib | 1 | 1,755 | 1 |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 868 | 2 |
| serious | Neutropenia | Blood and lymphatic system disorders | Celecoxib | 0 | 1,755 | 0 |
| serious | Neutropenia | Blood and lymphatic system disorders | Placebo | 2 | 868 | 2 |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Celecoxib | 203 | 1,763 |
| Total, all-cause mortality | Placebo | 104 | 876 |
| Total, other adverse events | Celecoxib | 298 | 1,755 |
| Total, other adverse events | Placebo | 151 | 868 |
| Total, serious adverse events | Celecoxib | 148 | 1,755 |
| Total, serious adverse events | Placebo | 64 | 868 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34264305 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Celecoxib vs Placebo: Number of Participants With Incidence of Second Primary Breast Cancers | Trial comparisons |
| Celecoxib vs Placebo: Cardiovascular Mortality | Trial comparisons |
| Celecoxib vs Placebo: deaths from any cause | Trial comparisons |
| Celecoxib vs Placebo: 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/NCT02429427
GET https://conductscience.org/api/trials/v1/NCT02429427/events?page=2