Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer

• Sponsor: Intarcia Therapeutics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00267553
• Collaborator: (none)
• Enrollment: 200
• Locations: 35
• Duration (Months): 7
• Patients Per Site: 5.7
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms; Neoplasms, Hormone-Dependent	Drug: Atamestane; Drug: toremifene; Drug: letrozole	Phase 3

Detailed Description

Aromatase is an enzyme expressed in tissues such as muscle and fat in postmenopausal women. These non-ovarian tissues become the dominant sources of estrogen in postmenopausal women. Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens from androgenic precursors in the body via the aromatase enzyme. Toremifene blocks circulating and intracellular estrogens from stimulating estrogen receptors in breast cancer cells. The goal of therapy with atamestane, an aromatase inhibitor, in combination with the estrogen receptor antagonist, toremifene, is to achieve complete suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combined hormonal therapy will lengthen the time to disease progression and the survival time for subjects with advanced breast cancer.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
• Study Start Date: Nov 1, 2005
• Actual Study Completion Date: Jun 1, 2006

Outcome Measures

Primary Outcome Measures

1. In conjunction with the data from Biomed 777-CLP-29, compare the time to progression (TTP) in the atamestane plus toremifene arm to the TTP in the letrozole plus placebo arm []

Secondary Outcome Measures

1. In conjunction with the data from Biomed 777-CLP-29, obtain safety, survival and time to treatment failure (TTF) data for both arms in this continuation study. []

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• To be eligible to receive continued treatment, subjects must remain eligible to receive study drug at the time of their last Biomed 777-CLP-29 visit

• To continue on survival follow-up, subjects must be in survival follow-up in study Biomed 777-CLP-29

• Written informed consent obtained for subjects who continue study drug treatment

Exclusion Criteria:

• Subjects who have withdrawn consent to participate in Biomed 777-CLP-29 for any reason

• Subjects for whom the investigator considers study participation is no longer in the best interest of those subjects.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Greenbrae	California	United States
2		St. Joseph	Michigan	United States
3		Kansas City	Missouri	United States
4		Houston	Texas	United States
5		Norfolk	Virginia	United States
6		Lacey	Washington	United States
7		Ottawa	Ontario	Canada
8		Thunder Bay	Ontario	Canada
9		Montreal	Quebec	Canada
10		Arkhangelsk		Russian Federation
11		Kazan		Russian Federation
12		Krasnodar		Russian Federation
13		Leningrad Region		Russian Federation
14		Lipetsk		Russian Federation
15		Moscow		Russian Federation
16		Murmansk		Russian Federation
17		N. Novgorod		Russian Federation
18		Novgorod		Russian Federation
19		Novosibirsk		Russian Federation
20		Obninsk		Russian Federation
21		Ryazan		Russian Federation
22		Samara		Russian Federation
23		St. Petersburg		Russian Federation
24		Stavropol		Russian Federation
25		Tomsk		Russian Federation
26		Voronezh		Russian Federation
27		Dnepropetrovsk		Ukraine
28		Donetsk		Ukraine
29		Ivano-Frankovsk		Ukraine
30		Kharkov		Ukraine
31		Kiev		Ukraine
32		Krivoy Rog		Ukraine
33		Lviv		Ukraine
34		Odessa		Ukraine
35		Uzhgorod		Ukraine

Sponsors and Collaborators

• Intarcia Therapeutics

Investigators

• Study Director: Peter Langecker, MD, PhD, Intarcia Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00267553
• Other Study ID Numbers: Biomed 777-CLP-32
• First Posted: Dec 21, 2005
• Last Update Posted: Sep 10, 2007
• Last Verified: Sep 1, 2007

• Keywords provided by , ,: Atamestane; Breast neoplasms; Combined hormonal therapy; Complete estrogen blockade; Ductal breast carcinoma; Estrogen blocker; Fareston®; Femara®; First line therapy; Letrozole; Lobular breast carcinoma; Locally advanced breast cancer; Locally recurrent breast cancer; Maximal estrogen inhibition; Metastatic breast cancer; Neoplasms, Hormone-dependent; Receptor-positive; Stage IIIA breast cancer; Stage IIIB breast cancer; Stage IV breast cancer; Toremifene
• Additional relevant MeSH terms: Breast Neoplasms; Neoplasms; Neoplasms, Hormone-Dependent; Toremifene; Letrozole; Atamestane

Study Results

No Results Posted as of Sep 10, 2007