Clinical trial NCT00267553: Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer
Official title: Open Label Treatment and Survival Continuation Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Neoplasms
Neoplasms, Hormone-Dependent
Keywords: 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
Lead sponsor: Intarcia Therapeutics
Sponsor class: INDUSTRY
First posted: 2005-12-21
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
city: Greenbrae
country: United States
state: California
city: St. Joseph
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Lacey
country: United States
state: Washington
city: Ottawa
country: Canada
state: Ontario
city: Thunder Bay
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Arkhangelsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Leningrad Region
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Murmansk
country: Russian Federation
city: N. Novgorod
country: Russian Federation
city: Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Samara
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankovsk
country: Ukraine
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Krivoy Rog
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Uzhgorod
country: Ukraine
Study officials:
affiliation: Intarcia Therapeutics
name: Peter Langecker, MD, PhD
role: STUDY_DIRECTOR
References: