Table 2.

Clinical trials of celecoxib +/− aromatase inhibitors or other chemotherapy for breast cancer

Trial/Subject Population	Drug Combination and Treatment Duration	Primary Outcome Measure(s)	Subject Number	Accrual Period	Follow-up Period
Celecoxib alone
Postmenopausal women (50–80 yrs of age) with Stage I–II breast cancer (Martin et al. 2010)	Randomized 2:1 to neoadjuvant celecoxib (400 mg bid) or no no treatment for 14 days	Change in Ki67 staining of core biopsy	23	NS	NA
Celecoxib + Aromatase Inhibitor
Postmenopausal women with hormone-sensitive breast cancer and progression after tamoxifen (Dirix et al. 2008)	Randomized to exemestane (25 mg/d) +/− celecoxib (400 mg bid)	Rate of clinical benefit	111	1/02–10/02	NS
Celecoxib Anti-Aromatase Neoadjuvant (CAAN) trial, postmenopausal women with invasive hormone-sensitive breast cancer (Chow et al. 2008)	Randomized to letrozole (2.5 mg/d) or exemestane (25 mg/d) +/− celecoxib (400 mg bid) for 3 mos neoadjuvant with treatment continued post-surgery for ≥2 yrs in responders	Clinical and pathological response	82	11/01–4/04	3 mos
Postmenopausal women with ER and/or PR positive metastatic breast cancer and lesions >1 cm diameter (Falandry et al. 2009)	Randomized to exemestane (25 mg/d) + celecoxib (400 mg bid, 6 mos) or placebo (5.6 mos)a	Progression-free survival	157	9/03–12/04	Median: 24 mos
Celecoxib + Other Chemotherapy
Pre- and postmenopausal women with metastatic breast cancer and recurrence with taxanes and/or anthracyclines (Fabi et al. 2008)	Single arm study: Capecitabine (1000 mg/m2 bid) on days 1–14 of 21 day cycle + celecoxib (200 mg bid) until disease progression or toxicity	Time to progression, safety	42	2/04–10/06	Median: 15 mos
Women aged 18–65 with stage II–III invasive breast cancer (Pierga et al. 2010)	Neoadjuvant 4 cycles epirubicin 75 mg/m2)-cyclophosphamide (750 mg/m2) then docetaxel (100 mg/m2) with randomization to concurrent celecoxib (400 mg bid) for HER2− patients with 3 wk cycles	Pathological tumor response	340	5/04–10/07	24 wks
Pre- and postmenopausal women with invasive breast cancer (Chow et al. 2013)	Single arm study: Neoadjuvant 4 cycles FEC (500, 100, 500 mg/m2) then 4 cycles docetaxel (100 mg/m2) + celecoxib (200 mg bid) with 3 wk cycles	Pathological complete response, objective response rate	64	2/06–1/10	Median: 50 mos

Abbreviations: bid: 2 times/day; d: day; FEC: 5-fluorouracil/epirubicin/cyclophosphamide; mos: months; NA: not applicable; NS: not specified; wk: week; yrs: years.

^aTime periods indicate median treatment duration as study was terminated prematurely due to reports of celecoxib’s cardiovascular toxicity.