Trial Outcomes & Findings for Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer (NCT NCT00201773)

NCT ID: NCT00201773

Last Updated: 2015-06-30

Results Overview

Collected from postmenopausal women that receive neoadjuvant exemestane.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

up to 16 weeks

Results posted on

2015-06-30

Participant Flow

Enrollment of postmenopausal women between January 2003 and July 2007

Participant milestones

Participant milestones
Measure	Exemestane & Celecoxib Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane. Exemestane: 25 mg orally once per day for 16 weeks. Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food. Correlative studies
Overall Study STARTED	22
Overall Study Completed 8 Weeks of Planned Therapy	16
Overall Study Received All Exemestane Therapy	5
Overall Study Stopped Exemestane After 4 Weeks	1
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exemestane & Celecoxib n=22 Participants Patients will received exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane. Exemestane: 25 mg orally once per day for 16 weeks. Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day and instructed to take the drug with food. Correlative studies
Age, Continuous	63 years n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	22 patients n=99 Participants
ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1	22 patients n=99 Participants
Menopause Status of Postmenopausal	22 patients n=99 Participants
Progesterone Receptor status Positive	16 patients n=99 Participants
Progesterone Receptor status Negative	6 patients n=99 Participants
Her-2 FISH Positive	4 patients n=99 Participants
Her-2 FISH Negative	8 patients n=99 Participants
Her-2 FISH Not available	10 patients n=99 Participants
Histology Invasive	15 patients n=99 Participants
Histology Lobular	5 patients n=99 Participants
Histology Mixed invasive and lobular	2 patients n=99 Participants
Clinical Axillary Status Positive	7 patients n=99 Participants
Clinical Axillary Status Negative	15 patients n=99 Participants
Axillary Nodal Evaluation Fine needle aspiration	2 patients n=99 Participants
Axillary Nodal Evaluation Sentinel	1 patients n=99 Participants
Clinical Stage I (cancer cells confined to limited area)	1 patients n=99 Participants
Clinical Stage IIA (evidence cancer has begun to grow/spread)	14 patients n=99 Participants
Clinical Stage IIB (tumor between 2-5 cm or larger)	3 patients n=99 Participants
Clinical Stage IIIA (cancer considered advanced)	3 patients n=99 Participants
Clinical Stage Occult primary (axillary metastases)	1 patients n=99 Participants

PRIMARY outcome

Timeframe: up to 16 weeks

Population: Comparison of immunohistochemistry (IHC) Allred Differences with Neoadjuvant Therapy

Collected from postmenopausal women that receive neoadjuvant exemestane.

Outcome measures

Outcome measures
Measure	Exemestane + Celecoxib n=14 Participants Exemestane + celecoxib (16 weeks) vs. Baseline	Exemestane n=9 Participants Exemestane (8 weeks) vs. Baseline
Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane	0 patients	0 patients

SECONDARY outcome

Timeframe: up to 16 weeks

Population: Clinical Response was determined by physical exam and breast Ultrasound at baseline and repeated at 8 weeks and 16 weeks, and pathological response by histopathological examination of primary tumor and axillary nodes after definitive breast cancer surgery.

Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, \<30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Exemestane + Celecoxib n=22 Participants Exemestane + celecoxib (16 weeks) vs. Baseline	Exemestane Exemestane (8 weeks) vs. Baseline
Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women. Complete Response	0 patients	—
Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women. Partial Response	5 patients	—
Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women. Stable Disease	1 patients	—
Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women. Progressive Disease	1 patients	—
Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women. Non-measurable	15 patients	—

Adverse Events

Exemestane Alone

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Exemestane + Celecoxib

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Steven Provoski, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-8700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Exemestane Alone n=22 participants at risk Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane. Exemestane: 25 mg orally once per day for 16 weeks. Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.	Exemestane + Celecoxib n=22 participants at risk Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane. Exemestane: 25 mg orally once per day for 16 weeks. Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.
Musculoskeletal and connective tissue disorders Myalgias	4.5% 1/22 • Number of events 1 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Musculoskeletal and connective tissue disorders Arthralgia	40.9% 9/22 • Number of events 9 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	22.7% 5/22 • Number of events 5 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Gastrointestinal disorders Heartburn	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	18.2% 4/22 • Number of events 4 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Gastrointestinal disorders Nausea	4.5% 1/22 • Number of events 1 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	13.6% 3/22 • Number of events 3 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Gastrointestinal disorders Abdominal Pain	4.5% 1/22 • Number of events 1 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	22.7% 5/22 • Number of events 5 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Gastrointestinal disorders Constipation	13.6% 3/22 • Number of events 3 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	9.1% 2/22 • Number of events 2 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Gastrointestinal disorders Diarrhea	4.5% 1/22 • Number of events 1 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
General disorders Fatigue	45.5% 10/22 • Number of events 10 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	27.3% 6/22 • Number of events 6 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Vascular disorders Hot Flashes	40.9% 9/22 • Number of events 9 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	27.3% 6/22 • Number of events 6 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Skin and subcutaneous tissue disorders Rash	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	4.5% 1/22 • Number of events 1 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Vascular disorders Edema	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	9.1% 2/22 • Number of events 2 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Renal and urinary disorders Renal Insufficiency	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	4.5% 1/22 • Number of events 1 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Vascular disorders Hypertension	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	18.2% 4/22 • Number of events 4 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Nervous system disorders Sensory Neuropathy	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	4.5% 1/22 • Number of events 1 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
Gastrointestinal disorders Lower Gastrointestional Bleed	0.00% 0/22 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.	9.1% 2/22 • Number of events 2 Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.