Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00083993

Collaborator

(none)

1,236

Enrollment

129

Locations

Duration (Months)

9.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival.

Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms Neoplasm Metastasis	Drug: Temsirolimus (CCI-779) for 34 months Drug: Letrozole for 34 months	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Oct 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

To determine overall progression free survival. []

Secondary Outcome Measures

To determine safety, survival, health outcomes, prognostic markers and pharmacogenomics analysis. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women aged greater than 18 years.
Postmenopausal subjects
Confirmed diagnosis of locally advanced (not amenable to curative surgery and/or radiation) or metastatic breast cancer (Stage 3B or 4 respectively, by American Joint Committee on Cancer Criteria)

Exclusion Criteria:

Extensive visceral disease
Subjects with bone as the only site of disease
Prior radiation therapy to the site of measurable disease for subjects with a solitary measurable lesion

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Hoover	Alabama	United States	35216
2	Huntsville	Alabama	United States	35801
3	Tucson	Arizona	United States	85715
4	Jonesboro	Arkansas	United States	72401
5	Burbank	California	United States	91505
6	Campbell	California	United States	95008
7	Fountain Valley	California	United States	92708
8	Gilroy	California	United States	95020
9	Glendora	California	United States	91740
10	Modesto	California	United States	95355
11	Montebello	California	United States	90640
12	Pomona	California	United States	91767
13	Poway	California	United States	92064
14	Sacramento	California	United States	95816
15	San Diego	California	United States	92123
16	Santa Rosa	California	United States	95405
17	Soquel	California	United States	95073
18	Vista	California	United States	92083
19	Lakewood	Colorado	United States	80215
20	Norwalk	Connecticut	United States	06851
21	Washington	District of Columbia	United States	20010
22	Boca Raton	Florida	United States	33428
23	Fort Lauderdale	Florida	United States	33305
24	Hollywood	Florida	United States	33021
25	Jacksonville	Florida	United States	32209
26	Jacksonville	Florida	United States	32224
27	Lake Worth	Florida	United States	33461
28	Miami Shores	Florida	United States	33138
29	New Port Richey	Florida	United States	34652
30	Plantation	Florida	United States	33324
31	Sarasota	Florida	United States	34239
32	Zephyrhills	Florida	United States	33542
33	Atlanta	Georgia	United States	30309-1710
34	Columbus	Georgia	United States	31902
35	Roswell	Georgia	United States	30076
36	Thomasville	Georgia	United States	31792
37	Coeur d'Alene	Idaho	United States	83814
38	Centralia	Illinois	United States	62801
39	Skokie	Illinois	United States	60076
40	Skokie	Illinois	United States	60077
41	Springfield	Illinois	United States	62702
42	Urbana	Illinois	United States	61801
43	Munster	Indiana	United States	46321
44	South Bend	Indiana	United States	46601
45	Lexington	Kentucky	United States	40504
46	Baltimore	Maryland	United States	21201
47	Baltimore	Maryland	United States	21231
48	Baltimore	Maryland	United States	21237
49	Bethesda	Maryland	United States	20817
50	Frederick	Maryland	United States	21701
51	Towson	Maryland	United States	21204
52	Boston	Massachusetts	United States	02118
53	Boston	Massachusetts	United States	02135
54	Ann Arbor	Michigan	United States	48109
55	Detroit	Michigan	United States	48202
56	Flint	Michigan	United States	48503
57	Grand Rapids	Michigan	United States	49503
58	Grand Rapids	Michigan	United States	49546
59	Minneapolis	Minnesota	United States	55455
60	Hattiesburg	Mississippi	United States	39401
61	Rolla	Missouri	United States	65401
62	Great Falls	Montana	United States	59406
63	Omaha	Nebraska	United States	68198
64	Carson City	Nevada	United States	89703
65	Lebanon	New Hampshire	United States	03756
66	Belleville	New Jersey	United States	07109
67	Somerset	New Jersey	United States	08873
68	Albuquerque	New Mexico	United States	87109
69	Binghamton	New York	United States	13905
70	East Syracuse	New York	United States	13057
71	New York	New York	United States	10032
72	Nyack	New York	United States	10960
73	Staten Island	New York	United States	10305
74	Charlotte	North Carolina	United States	28203
75	Gastonia	North Carolina	United States	28054
76	Wilmington	North Carolina	United States	28401
77	Winston-Salem	North Carolina	United States	27103
78	Bismark	North Dakota	United States	58504
79	Canton	Ohio	United States	44710
80	Canton	Ohio	United States	44718
81	Cincinnati	Ohio	United States	45219
82	Cincinnati	Ohio	United States	45238
83	Cleveland	Ohio	United States	44106-5055
84	Cleveland	Ohio	United States	44195
85	Columbus	Ohio	United States	43215
86	Columbus	Ohio	United States	43235
87	Mayfield Heights	Ohio	United States	44124
88	Corvallis	Oregon	United States	97330
89	Portland	Oregon	United States	97213
90	Harrisburg	Pennsylvania	United States	17110
91	Hershey	Pennsylvania	United States	17033
92	Langhorne	Pennsylvania	United States	19047
93	Philadelphia	Pennsylvania	United States	19106
94	Pittsburgh	Pennsylvania	United States	15213
95	Charleston	South Carolina	United States	29425
96	Columbia	South Carolina	United States	29169
97	Chattanooga	Tennessee	United States	37404
98	Nashville	Tennessee	United States	37203
99	Nashville	Tennessee	United States	37205
100	Arlington	Texas	United States	76012
101	Corpus Christi	Texas	United States	78412
102	Dallas	Texas	United States	75230
103	Fort Worth	Texas	United States	76104
104	Irving	Texas	United States	75038
105	Tyler	Texas	United States	75701
106	Logan	Utah	United States	84341
107	Ogden	Utah	United States	84403
108	Arlington	Virginia	United States	22205-3637
109	Richmond	Virginia	United States	23294
110	Woodbridge	Virginia	United States	22191
111	Seattle	Washington	United States	98101
112	Morgantown	West Virginia	United States	26505
113	Calgary	Alberta	Canada	T2N4N2
114	North Vancouver	British Columbia	Canada	V7L 2L7
115	Richmond	British Columbia	Canada	V6X1A2
116	Halifax	Nova Scotia	Canada	B3H 1V7
117	Barrie	Ontario	Canada	L4M 6M2
118	Hamilton	Ontario	Canada	L8V 5C2
119	Newmarket	Ontario	Canada	L3Y 2P9
120	Toronto	Ontario	Canada	M4C-3E7
121	Toronto	Ontario	Canada	M4N 3N5
122	Toronto	Ontario	Canada	M5G 1X5
123	Toronto	Ontario	Canada	M5G 2m9
124	Chicoutimi	Quebec	Canada	G7H 5H6
125	Fleurimont	Quebec	Canada	J1H 5N4
126	Levis	Quebec	Canada	G1V3Z1
127	Pointe Claire	Quebec	Canada	H9R4S3
128	Quebec City	Quebec	Canada	G1R2J6
129	Saskatoon	Saskatchewan	Canada	S7N4H4