Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00038103
• Collaborator: (none)
• Enrollment: 111
• Locations: 20
• Arms: 2
• Duration (Months): 74
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on tamoxifen.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: Exemestane; Drug: Celecoxib + Exemestane	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Multicentre, Controlled Study Of Exemestane (Aromasin®) With Or Without Celecoxib (Celebrex®) In Postmenopausal Women With Advanced Breast Cancer (ABC) Having Progressed On Tamoxifen
• Study Start Date: Jan 1, 2002
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1.	Drug: Exemestane; Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.; Other Names: Aromasin
Experimental: 2.	Drug: Celecoxib + Exemestane; Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.; Other Names: Celebrex, Aromasin

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Clinical Benefit [Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)]

   Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.

Secondary Outcome Measures

1. Number of Subjects With Objective Response [Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV]

   Objective tumor response includes subjects with CR or PR according to RECIST.

2. Duration of Clinical Benefit [Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV]

   Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.

3. Duration of Objective Response (in Subjects With CR or PR) [Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV]

   Time from the first objective documentation of response until the first objective documentation of tumor progression.

4. Duration of Long-Term SD [Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV]

   Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.

5. Time to Tumor Progression [Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV]

   Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.

6. Time to Treatment Failure [Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV]

   Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.

7. Survival [Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death]

   Time from randomization to date of death (any cause).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.

• Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.

• at least one measurable lesion

Exclusion Criteria:

• More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.

• Previous hormonotherapy for advanced disease other than Tamoxifen.

• Myocardial infarction within previous 6 mo

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Dallas	Texas	United States	75204
2	Pfizer Investigational Site	Antwerpen		Belgium	2020
3	Pfizer Investigational Site	Bruxelles		Belgium	1000
4	Pfizer Investigational Site	Leuven		Belgium	3000
5	Pfizer Investigational Site	Namur		Belgium	5000
6	Pfizer Investigational Site	Wilrijk		Belgium	2610
7	Pfizer Investigational Site	Porto Alegre	RS	Brazil	90610-000
8	Pfizer Investigational Site	Sao Paulo	SP	Brazil	01509-900
9	Pfizer Investigational Site	Sydney	Nova Scotia	Canada	B1P 1P3
10	Pfizer Investigational Site	Bogota	Bogota . DC	Colombia
11	Pfizer Investigational Site	Cali		Colombia
12	Pfizer Investigational Site	Hyderabad	Andhra Pradesh	India	500 082
13	Pfizer Investigational Site	Bangalore	Karnataka	India	560 029
14	Pfizer Investigational Site	Mumbai	Maharashtra	India	400 012
15	Pfizer Investigational Site	Pune	Maharashtra	India	41101
16	Pfizer Investigational Site	Mexico	Distrito Federal	Mexico	07760
17	Pfizer Investigational Site	Guadalajara	Jalisco	Mexico	44280
18	Pfizer Investigational Site	Lima		Peru	11
19	Pfizer Investigational Site	Lima		Peru	34
20	Pfizer Investigational Site	Manila		Philippines	1000

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00038103
• Other Study ID Numbers: NQ8-01-02-013; A3191139
• First Posted: May 30, 2002
• Last Update Posted: Feb 25, 2010
• Last Verified: Feb 1, 2010

• Additional relevant MeSH terms: Breast Neoplasms; Celecoxib; Exemestane

Study Results

Participant Flow

Pre-assignment Detail	2 subjects in the exemestane arm were never treated. One subject refused to be treated having originally consented to participate in this study and the other, reason for not starting treatment was unknown

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Period Title: Overall Study
STARTED	55	56
End of Treatment	53	56
COMPLETED	0	0
NOT COMPLETED	55	56

Baseline Characteristics

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)	Total
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)	Total of all reporting groups
Overall Participants	55	56	111
Age, Customized (Number) [Number]
< 50 years	20.0 36.4%	16.0 28.6%	36.0 32.4%
50-64 years	20.0 36.4%	27.0 48.2%	47.0 42.3%
65-79 years	15.0 27.3%	12.0 21.4%	27.0 24.3%
=> 80 years	0.0 0%	1.0 1.8%	1.0 0.9%
Sex: Female, Male (Count of Participants)
Female	55 100%	56 100%	111.0 100%
Male	0 0%	0 0%	0.0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Clinical Benefit
Description	Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.
Time Frame	Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Measure Participants	49	51
Number [participants]	24 43.6%	24 42.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exemestane (Exemestane Alone)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Clinical Benefit Rate
	Estimated Value	49.0
	Confidence Interval	() 95%; 34.4 to 63.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combination (Exemestane + Celecoxib)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Clinical Benefit Rate
	Estimated Value	47.1
	Confidence Interval	() 95%; 32.9 to 61.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Number of subjects showing clinical benefits out of the number of subjects in the evaluable set.

2. Secondary Outcome

Title	Number of Subjects With Objective Response
Description	Objective tumor response includes subjects with CR or PR according to RECIST.
Time Frame	Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Measure Participants	49	51
Number [participants]	11 20%	12 21.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Exemestane (Exemestane Alone)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Objective Response Rate
	Estimated Value	22.4
	Confidence Interval	() 95%; 11.8 to 36.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Number of subjects showing objective response out of the number of subjects in the evaluable set.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Combination (Exemestane + Celecoxib)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Objective Response Rate
	Estimated Value	23.5
	Confidence Interval	() 95%; 12.8 to 37.5
	Parameter Dispersion	Type: Value:
	Estimation Comments	Number of subjects showing objective response out of the number of subjects in the evaluable set.

3. Secondary Outcome

Title	Duration of Clinical Benefit
Description	Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.
Time Frame	Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV

Outcome Measure Data

Analysis Population Description

Evaluable population. Number of participants analyzed = number of subjects with clinical benefit.

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Measure Participants	24	24
Median (95% Confidence Interval) [weeks]	49.1	96.6

4. Secondary Outcome

Title	Duration of Objective Response (in Subjects With CR or PR)
Description	Time from the first objective documentation of response until the first objective documentation of tumor progression.
Time Frame	Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV

Outcome Measure Data

Analysis Population Description

Evaluable population. Number of participants analyzed = number of subjects with objective response.

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Measure Participants	11	12
Median (95% Confidence Interval) [weeks]	32.7	40.1

5. Secondary Outcome

Title	Duration of Long-Term SD
Description	Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.
Time Frame	Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV

Outcome Measure Data

Analysis Population Description

Evaluable population. Number of participants analyzed = number of subjects with long-term SD.

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Measure Participants	13	12
Median (95% Confidence Interval) [weeks]	52.9	109.7

6. Secondary Outcome

Title	Time to Tumor Progression
Description	Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.
Time Frame	Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Measure Participants	49	51
Median (95% Confidence Interval) [weeks]	20	23.4

7. Secondary Outcome

Title	Time to Treatment Failure
Description	Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.
Time Frame	Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Measure Participants	49	51
Median (95% Confidence Interval) [Weeks]	18.1	20.4

8. Secondary Outcome

Title	Survival
Description	Time from randomization to date of death (any cause).
Time Frame	Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death

Outcome Measure Data

Analysis Population Description

Evaluable population

Arm/Group Title	Exemestane (Exemestane Alone)	Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)	oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
Measure Participants	49	51
Median (95% Confidence Interval) [weeks]	74.4	73.9

Adverse Events

Arm/Group Title	Exemestane (Exemestane Alone)		Combination (Exemestane + Celecoxib)
Arm/Group Description	oral dose exemestane taken with food (25 mg tablet once daily)		oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
All Cause Mortality
	Exemestane (Exemestane Alone)		Combination (Exemestane + Celecoxib)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Exemestane (Exemestane Alone)		Combination (Exemestane + Celecoxib)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/ (NaN)		14/ (NaN)
Cardiac disorders
Cardiac Failure Congestive	0/53 (0%)		1/56 (1.8%)
Gastrointestinal disorders
Ascites	1/53 (1.9%)		0/56 (0%)
Nausea	1/53 (1.9%)		0/56 (0%)
Vomiting	2/53 (3.8%)		0/56 (0%)
Intestinal Obstruction	1/53 (1.9%)		0/56 (0%)
Diarrhoea	0/53 (0%)		1/56 (1.8%)
General disorders
Pain	1/53 (1.9%)		1/56 (1.8%)
Death	1/53 (1.9%)		1/56 (1.8%)
General physical health deterioration	1/53 (1.9%)		1/56 (1.8%)
Gait Disturbance	1/53 (1.9%)		1/56 (1.8%)
Asthenia	2/53 (3.8%)		0/56 (0%)
Fatigue	0/53 (0%)		1/56 (1.8%)
Back Pain	0/53 (0%)		1/56 (1.8%)
Hepatobiliary disorders
Jaundice	2/53 (3.8%)		0/56 (0%)
Injury, poisoning and procedural complications
Fall	0/53 (0%)		1/56 (1.8%)
Musculoskeletal and connective tissue disorders
Neck Pain	1/53 (1.9%)		0/56 (0%)
Scleroderma	0/53 (0%)		1/56 (1.8%)
Wrist Fracture	0/53 (0%)		1/56 (1.8%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm	0/53 (0%)		1/56 (1.8%)
Breast Cancer	0/53 (0%)		1/56 (1.8%)
Nervous system disorders
Asterixis	1/53 (1.9%)		0/56 (0%)
Miller Fisher Syndrome	0/53 (0%)		1/56 (1.8%)
Polyneuropathy	0/53 (0%)		1/56 (1.8%)
Paresis	0/53 (0%)		1/56 (1.8%)
Psychiatric disorders
Disorientation	1/53 (1.9%)		0/56 (0%)
Dizziness	1/53 (1.9%)		0/56 (0%)
Reproductive system and breast disorders
Post procedural complication	1/53 (1.9%)		0/56 (0%)
Respiratory, thoracic and mediastinal disorders
Lung Disorder	1/53 (1.9%)		0/56 (0%)
Dyspnoea	2/53 (3.8%)		3/56 (5.4%)
Cough	1/53 (1.9%)		0/56 (0%)
Pleural Effusion	0/53 (0%)		1/56 (1.8%)
Skin and subcutaneous tissue disorders
Dermatitis Allergic	0/53 (0%)		1/56 (1.8%)
Surgical and medical procedures
Knee Arthroplasty	0/53 (0%)		1/56 (1.8%)
Vascular disorders
Deep Vein Thrombosis	1/53 (1.9%)		1/56 (1.8%)
Other (Not Including Serious) Adverse Events
	Exemestane (Exemestane Alone)		Combination (Exemestane + Celecoxib)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/ (NaN)		43/ (NaN)
Blood and lymphatic system disorders
Anaemia	0/53 (0%)		2/53 (3.8%)
Cardiac disorders
Cardiac failure congestive	0/53 (0%)		1/53 (1.9%)
Ear and labyrinth disorders
Tinnitus	1/53 (1.9%)		0/53 (0%)
Vertigo	1/53 (1.9%)		1/53 (1.9%)
Eye disorders
Conjunctivitis	1/53 (1.9%)		0/53 (0%)
Visual impairment	0/53 (0%)		1/53 (1.9%)
Gastrointestinal disorders
Abdominal pain	2/53 (3.8%)		3/53 (5.7%)
Abdominal pain upper	2/53 (3.8%)		3/53 (5.7%)
Ascites	1/53 (1.9%)		0/53 (0%)
Cheilitis	1/53 (1.9%)		0/53 (0%)
Constipation	4/53 (7.5%)		0/53 (0%)
Diarrhoea	3/53 (5.7%)		5/53 (9.4%)
Dysphagia	1/53 (1.9%)		0/53 (0%)
Faecal incontinence	1/53 (1.9%)		1/53 (1.9%)
Gastritis	1/53 (1.9%)		2/53 (3.8%)
Intestinal obstruction	1/53 (1.9%)		0/53 (0%)
Nausea	5/53 (9.4%)		3/53 (5.7%)
Odynophagia	1/53 (1.9%)		0/53 (0%)
Oesophagitis	1/53 (1.9%)		0/53 (0%)
Peptic ulcer	1/53 (1.9%)		0/53 (0%)
Toothache	1/53 (1.9%)		0/53 (0%)
Vomiting	8/53 (15.1%)		2/53 (3.8%)
Abdominal discomfort	0/53 (0%)		1/53 (1.9%)
Gastrointestinal pain	0/53 (0%)		1/53 (1.9%)
Mouth ulceration	0/53 (0%)		1/53 (1.9%)
Dyspepsia	0/53 (0%)		2/53 (3.8%)
General disorders
Asthenia	4/53 (7.5%)		6/53 (11.3%)
Axillary pain	1/53 (1.9%)		0/53 (0%)
Chest pain	2/53 (3.8%)		2/53 (3.8%)
Death	1/53 (1.9%)		0/53 (0%)
Fatigue	4/53 (7.5%)		3/53 (5.7%)
Gait disturbance	2/53 (3.8%)		2/53 (3.8%)
General physical health deterioration	1/53 (1.9%)		1/53 (1.9%)
Inflammation	1/53 (1.9%)		0/53 (0%)
Oedema	1/53 (1.9%)		0/53 (0%)
Oedema peripheral	2/53 (3.8%)		2/53 (3.8%)
Pain	2/53 (3.8%)		2/53 (3.8%)
Pyrexia	1/53 (1.9%)		0/53 (0%)
Ulcer haemorrhage	1/53 (1.9%)		0/53 (0%)
Malaise	0/53 (0%)		1/53 (1.9%)
Hepatobiliary disorders
Jaundice	2/53 (3.8%)		1/53 (1.9%)
Immune system disorders
Hypersensitivity	1/53 (1.9%)		0/53 (0%)
Infections and infestations
Fungal infection	1/53 (1.9%)		0/53 (0%)
Gastroenteritis	1/53 (1.9%)		0/53 (0%)
Lymphangitis	1/53 (1.9%)		0/53 (0%)
Respiratory tract infection	2/53 (3.8%)		0/53 (0%)
Sinusitis	1/53 (1.9%)		1/53 (1.9%)
Upper respiratory tract infection	1/53 (1.9%)		1/53 (1.9%)
Urinary tract infection	1/53 (1.9%)		5/53 (9.4%)
Acarodermatitis	0/53 (0%)		1/53 (1.9%)
Breast cellulitis	0/53 (0%)		1/53 (1.9%)
Bronchitis	0/53 (0%)		3/53 (5.7%)
Bronchitis viral	0/53 (0%)		1/53 (1.9%)
Ear infection	0/53 (0%)		1/53 (1.9%)
Influenza	0/53 (0%)		2/53 (3.8%)
Nasopharyngitis	0/53 (0%)		2/53 (3.8%)
Tinea pedis	0/53 (0%)		1/53 (1.9%)
Tooth infection	0/53 (0%)		1/53 (1.9%)
Tracheitis	0/53 (0%)		1/53 (1.9%)
Injury, poisoning and procedural complications
Fall	1/53 (1.9%)		1/53 (1.9%)
Joint dislocation	1/53 (1.9%)		0/53 (0%)
Medical device complication	1/53 (1.9%)		0/53 (0%)
Post procedural complication	1/53 (1.9%)		0/53 (0%)
Wound	1/53 (1.9%)		0/53 (0%)
Wrist fracture	0/53 (0%)		1/53 (1.9%)
Investigations
Alanine aminotransferase increased	1/53 (1.9%)		1/53 (1.9%)
Aspartate aminotransferase	1/53 (1.9%)		1/53 (1.9%)
Blood alkaline phosphatase	2/53 (3.8%)		0/53 (0%)
Blood alkaline phosphatase increased	2/53 (3.8%)		0/53 (0%)
Gamma-glutamyltransferase	1/53 (1.9%)		1/53 (1.9%)
Low density lipoprotein	1/53 (1.9%)		0/53 (0%)
Neutrophil count decreased	1/53 (1.9%)		0/53 (0%)
Platelet count decreased	1/53 (1.9%)		0/53 (0%)
Weight decreased	2/53 (3.8%)		1/53 (1.9%)
Weight increased	2/53 (3.8%)		0/53 (0%)
White blood cell count decreased	1/53 (1.9%)		0/53 (0%)
Alanine aminotransferase	0/53 (0%)		1/53 (1.9%)
Hepatic enzyme increased	0/53 (0%)		1/53 (1.9%)
Pulse pressure increased	0/53 (0%)		1/53 (1.9%)
Metabolism and nutrition disorders
Anorexia	7/53 (13.2%)		3/53 (5.7%)
Diabetes mellitus	1/53 (1.9%)		0/53 (0%)
Hypercalcaemia	1/53 (1.9%)		0/53 (0%)
Hypercholesterolaemia	2/53 (3.8%)		0/53 (0%)
Hyperglycaemia	3/53 (5.7%)		1/53 (1.9%)
Hypertriglyceridaemia	2/53 (3.8%)		0/53 (0%)
Hypoalbuminaemia	1/53 (1.9%)		0/53 (0%)
Hypocalcaemia	4/53 (7.5%)		0/53 (0%)
Hypoglycaemia	1/53 (1.9%)		0/53 (0%)
Hypoproteinaemia	0/53 (0%)		1/53 (1.9%)
Musculoskeletal and connective tissue disorders
Arthralgia	5/53 (9.4%)		6/53 (11.3%)
Back pain	8/53 (15.1%)		10/53 (18.9%)
Bone pain	2/53 (3.8%)		5/53 (9.4%)
Joint stiffness	1/53 (1.9%)		0/53 (0%)
Muscular weakness	1/53 (1.9%)		0/53 (0%)
Musculoskeletal pain	1/53 (1.9%)		2/53 (3.8%)
Myalgia	3/53 (5.7%)		2/53 (3.8%)
Neck pain	1/53 (1.9%)		1/53 (1.9%)
Pain in extremity	7/53 (13.2%)		5/53 (9.4%)
Flank pain	0/53 (0%)		1/53 (1.9%)
Muscle spasms	0/53 (0%)		2/53 (3.8%)
Musculoskeletal chest pain	0/53 (0%)		1/53 (1.9%)
Musculoskeletal stiffness	0/53 (0%)		1/53 (1.9%)
Osteitis deformans	0/53 (0%)		1/53 (1.9%)
Pain in jaw	0/53 (0%)		1/53 (1.9%)
Rheumatoid arthritis	0/53 (0%)		1/53 (1.9%)
Scleroderma	0/53 (0%)		1/53 (1.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain	2/53 (3.8%)		0/53 (0%)
Breast cancer	0/53 (0%)		1/53 (1.9%)
Metastatic neoplasm	0/53 (0%)		1/53 (1.9%)
Nervous system disorders
Asterixis	1/53 (1.9%)		0/53 (0%)
Ataxia	1/53 (1.9%)		0/53 (0%)
Dizziness	2/53 (3.8%)		0/53 (0%)
Headache	5/53 (9.4%)		4/53 (7.5%)
Hypoaesthesia	1/53 (1.9%)		1/53 (1.9%)
Paraesthesia	2/53 (3.8%)		2/53 (3.8%)
Peripheral sensory neuropathy	1/53 (1.9%)		3/53 (5.7%)
Peroneal nerve palsy	1/53 (1.9%)		0/53 (0%)
Sensory loss	1/53 (1.9%)		0/53 (0%)
Brachial plexopathy	0/53 (0%)		1/53 (1.9%)
Carpal tunnel syndrome	0/53 (0%)		1/53 (1.9%)
Dysaesthesia	0/53 (0%)		1/53 (1.9%)
Dysarthria	0/53 (0%)		1/53 (1.9%)
Miller Fisher syndrome	0/53 (0%)		1/53 (1.9%)
Paresis	0/53 (0%)		1/53 (1.9%)
Polyneuropathy	0/53 (0%)		1/53 (1.9%)
Somnolence	0/53 (0%)		2/53 (3.8%)
Psychiatric disorders
Anxiety	1/53 (1.9%)		0/53 (0%)
Confusional state	1/53 (1.9%)		0/53 (0%)
Disorientation	1/53 (1.9%)		0/53 (0%)
Insomnia	3/53 (5.7%)		1/53 (1.9%)
Renal and urinary disorders
Dysuria	2/53 (3.8%)		0/53 (0%)
Proteinuria	3/53 (5.7%)		0/53 (0%)
Pyuria	1/53 (1.9%)		0/53 (0%)
Urinary incontinence	1/53 (1.9%)		0/53 (0%)
Urge incontinence	0/53 (0%)		1/53 (1.9%)
Reproductive system and breast disorders
Breast pain	1/53 (1.9%)		2/53 (3.8%)
Pelvic pain	1/53 (1.9%)		1/53 (1.9%)
Vaginal discharge	1/53 (1.9%)		0/53 (0%)
Vaginal haemorrhage	2/53 (3.8%)		0/53 (0%)
Vulvovaginal pruritus	1/53 (1.9%)		0/53 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	9/53 (17%)		4/53 (7.5%)
Dysphonia	2/53 (3.8%)		0/53 (0%)
Dyspnoea	4/53 (7.5%)		7/53 (13.2%)
Dyspnoea exertional	2/53 (3.8%)		0/53 (0%)
Epistaxis	1/53 (1.9%)		0/53 (0%)
Lung disorder	1/53 (1.9%)		0/53 (0%)
Pleural effusion	1/53 (1.9%)		1/53 (1.9%)
Productive cough	1/53 (1.9%)		0/53 (0%)
Wheezing	1/53 (1.9%)		0/53 (0%)
Oropharyngeal pain	0/53 (0%)		1/53 (1.9%)
Rhinorrhoea	0/53 (0%)		1/53 (1.9%)
Skin and subcutaneous tissue disorders
Dermatitis contact	1/53 (1.9%)		0/53 (0%)
Hyperhidrosis	2/53 (3.8%)		1/53 (1.9%)
Pruritus	3/53 (5.7%)		0/53 (0%)
Rash	3/53 (5.7%)		2/53 (3.8%)
Alopecia	0/53 (0%)		2/53 (3.8%)
Dermatitis	0/53 (0%)		1/53 (1.9%)
Dermatitis allergic	0/53 (0%)		1/53 (1.9%)
Eczema	0/53 (0%)		1/53 (1.9%)
Skin lesion	0/53 (0%)		1/53 (1.9%)
Surgical and medical procedures
Cholecystectomy	0/53 (0%)		1/53 (1.9%)
Knee arthroplasty	0/53 (0%)		1/53 (1.9%)
Vascular disorders
Deep vein thrombosis	1/53 (1.9%)		1/53 (1.9%)
Hot flush	6/53 (11.3%)		8/53 (15.1%)
Hypertension	1/53 (1.9%)		2/53 (3.8%)
Lymphoedema	1/53 (1.9%)		0/53 (0%)
Pallor	1/53 (1.9%)		1/53 (1.9%)
Phlebitis	1/53 (1.9%)		0/53 (0%)
Vasodilatation	1/53 (1.9%)		0/53 (0%)
Hypotension	0/53 (0%)		1/53 (1.9%)
Varicose vein	0/53 (0%)		1/53 (1.9%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.