European Celecoxib Trial in Primary Breast Cancer (REACT)
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ClinicalTrials.gov Identifier: NCT02429427 |
Recruitment Status :
Completed
First Posted : April 29, 2015
Results First Posted : June 23, 2020
Last Update Posted : June 23, 2020
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Breast Cancer |
Interventions |
Drug: Celecoxib Other: Placebo |
Enrollment | 2639 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Celecoxib | Placebo |
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Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice. |
Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food |
Period Title: Overall Study | ||
Started | 1763 | 876 |
Completed | 1392 | 697 |
Not Completed | 371 | 179 |
Reason Not Completed | ||
Adverse Event | 220 | 92 |
Protocol Violation | 10 | 6 |
Lost to Follow-up | 15 | 6 |
Withdrawal by Subject | 64 | 34 |
Other | 62 | 41 |
Arm/Group Title | Celecoxib | Placebo | Total | |
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Patients in this arm will receive 400mg of celecoxib once daily. In addition, Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Celecoxib: Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice. |
Patients in this arm will receive 2 tablets once daily. In addition Hormone Receptor (+) patients will receive endocrine treatment according to local practice. Placebo: Two capsules once daily with food |
Total of all reporting groups | |
Overall Number of Baseline Participants | 1763 | 876 | 2639 | |
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[Not Specified]
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
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Number Analyzed | 1763 participants | 876 participants | 2639 participants | |
55.2
(48.7 to 62.6)
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55.3
(48.6 to 63.0)
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55.2
(48.6 to 62.7)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1763 participants | 876 participants | 2639 participants | |
Female |
1763 100.0%
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876 100.0%
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2639 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Ethnicity | Number Analyzed | 1763 participants | 876 participants | 2639 participants |
Caucasian |
1689 95.8%
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848 96.8%
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2537 96.1%
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Asian |
29 1.6%
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8 0.9%
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37 1.4%
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Other |
21 1.2%
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10 1.1%
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31 1.2%
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Black Caribbean |
13 0.7%
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4 0.5%
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17 0.6%
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Black African |
8 0.5%
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4 0.5%
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12 0.5%
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Black Other |
3 0.2%
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2 0.2%
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5 0.2%
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Name/Title: | Prof Charles Coombes |
Organization: | Imperial College London |
Phone: | +44 20 7594 2135 |
EMail: | c.coombes@imperial.ac.uk |
Responsible Party: | Imperial College London |
ClinicalTrials.gov Identifier: | NCT02429427 |
Other Study ID Numbers: |
C/20/01 |
First Submitted: | April 15, 2015 |
First Posted: | April 29, 2015 |
Results First Submitted: | May 26, 2020 |
Results First Posted: | June 23, 2020 |
Last Update Posted: | June 23, 2020 |