Trial Outcomes & Findings for Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery (NCT NCT00665457)

Results Overview

Grading of adverse events was determine by the principal investigator according to NCI common toxicity criteria (CTC version 3.0). Safety analysis is based on any participant experiencing a grade 4 AE.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

every 3 weeks X 4, then every 2 weeks X4

Results posted on

2023-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	Celecoxib •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: standard of care
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biomarkers in Women Receiving Chemotherapy & Celecoxib for Stage II or Stage III Breast Cancer Removable by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Celecoxib n=3 Participants •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: standard of care
Age, Continuous	46.3 years n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Region of Enrollment United States	3 participants n=93 Participants

PRIMARY outcome

Timeframe: every 3 weeks X 4, then every 2 weeks X4

Population: Of the 3 participants, one had a grade 4 event - neutropenic fever.

Grading of adverse events was determine by the principal investigator according to NCI common toxicity criteria (CTC version 3.0). Safety analysis is based on any participant experiencing a grade 4 AE.

Outcome measures

Outcome measures
Measure	Celecoxib n=3 Participants •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: standard of care
Number of Participants With Grade 4 Adverse Events	1 Participants

PRIMARY outcome

Timeframe: 20 weeks

CTEP RECIST guidelines are defined as followed: Pathologic complete response is no signs of residual malignancy cells at the primary site and axillary lymph nodes are seen with histologic examination. Progression-free survival is defined as from the first date of therapy until the first notation of clinical progression or relapse. Overall survival is defined as from the first date of therapy until the date of death. Time to treatment failure is defined as from the first date of therapy until the date the patient is removed from study for any reason.

Outcome measures

Outcome measures
Measure	Celecoxib n=3 Participants •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: standard of care
Participants Who Experienced Pathologic Complete Response, Progression-free and Overall Survival, and Time to Treatment Failure pathologic complete response	0 Participants
Participants Who Experienced Pathologic Complete Response, Progression-free and Overall Survival, and Time to Treatment Failure progression free survival	1 Participants
Participants Who Experienced Pathologic Complete Response, Progression-free and Overall Survival, and Time to Treatment Failure overall survival	1 Participants
Participants Who Experienced Pathologic Complete Response, Progression-free and Overall Survival, and Time to Treatment Failure time to treatment failure	1 Participants

Adverse Events

Celecoxib

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Celecoxib n=3 participants at risk •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: standard of care
Immune system disorders Neutropenic Fever	33.3% 1/3 • Number of events 1

Other adverse events

Other adverse events
Measure	Celecoxib n=3 participants at risk •Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15, oral capecitabine twice daily on days 1-14, and oral celecoxib twice daily on days 1-21. Courses repeat every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive doxorubicin hydrochloride IV and cyclophosphamide IV once daily on day 1, oral celecoxib twice daily on days 1-14, and filgrastim subcutaneously once daily on days 3-10. Courses repeat every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Celecoxib is stopped one week prior to surgery. •Surgery: standard of care
Metabolism and nutrition disorders Weight Loss	33.3% 1/3
Immune system disorders Paronychia	100.0% 3/3
Hepatobiliary disorders Elevated Liver Enzymes	66.7% 2/3
Renal and urinary disorders Dysuria	33.3% 1/3
Eye disorders Lacrimal Stenosis	66.7% 2/3
Gastrointestinal disorders Intractable nausea and vomiting	33.3% 1/3
Immune system disorders Neutropenic fever	33.3% 1/3
Eye disorders Obstruction nasolacrimal duct	33.3% 1/3

Additional Information

Elizabeth Reed, M.D.

University of Nebraska Medical Center

Phone: 402-559-5388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place