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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00097344
Other study ID # Biomed 777-CLP-30
Secondary ID
Status Terminated
Phase Phase 3
First received November 22, 2004
Last updated August 21, 2007
Start date December 2004
Est. completion date August 2006

Study information

Verified date August 2007
Source Intarcia Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationRussia: Pharmacological Committee, Ministry of HealthUkraine: State Pharmacological Center - Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.


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 rate of objective response, as compared to single agent therapy with the approved aromatase inhibitor letrozole.


Recruitment information / eligibility

Status Terminated
Enrollment 842
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women age 18 years or older

- Postmenopausal women who are to receive their first hormonal treatment for locally recurrent, locally advanced, or metastatic disease, and who would be appropriate candidates for treatment with antiestrogens or aromatase inhibitors.

- Locally recurrent, locally advanced, locally metastatic disease not amenable to radiation therapy or surgery and/or distant metastatic disease.

- Pathological or histological confirmation at primary diagnosis of breast cancer or at the time of diagnosis of advanced disease.

- ECOG performance status of 0, 1 or 2 or Karnofsky performance status of 60 or higher.

- Predicted life expectancy of 12 weeks or more.

- Postmenopausal endocrine status. LH/FSH levels in the postmenopausal range in women whose menopause occurred less than 5 years ago.

- At least one tumor localization measurable in 2 dimensions.

- One diameter either at least 2 cm or at least two times the CT/MRI slice/reconstruction thickness for bone/soft tissue/visceral disease assessed by CT/MRI scan (to include spiral CT technique).

- One diameter at least 2 cm for lesions other than bone lesions assessed by conventional X-ray techniques.

- One diameter at least 1 cm for bone lesions assessed by conventional X-ray techniques.

- Estrogen receptor and/or progesterone receptor positive (by laboratory/institutional standard) at the time of primary diagnosis or determined during subsequent biopsy/surgery of metastases.

- Administration of bisphosphonates in patients with bone metastases is allowed, as long as the drug is started prior to randomization of the patient.

- Written informed consent obtained.

Exclusion Criteria:

- Prior hormonal therapy (including oophorectomy or treatment with LH/RH analogs) to treat locally recurrent, locally advanced, or metastatic disease.

- Prior chemotherapy to treat locally recurrent, locally advanced, or metastatic disease.

- Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs with last dose administered within 3 months prior to enrollment.

- Primary diagnosis of disease or progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis).

- Life-threatening disease requiring chemotherapeutic intervention.

- History of known CNS metastases, significant neurological dysfunction including active seizures, or clinical signs of other significant neurological diseases.

- Other active malignancy (except basal cell carcinoma of the skin, contralateral breast cancer, or in situ cervical cancer). Patients with previous malignancies must be without evidence of disease for at least five years.

- Renal insufficiency (serum creatinine >2.0 mg/dL).

- Aspartate aminotransferase, alanine aminotransferase, or serum bilirubin levels more than 2.5 times upper limit of normal.

- Hemoglobin <9 g/dL.

- Platelet count of less than 100,000 platelets per mm3.

- Total white blood cell count of less than 2,000 cells per mm3.

- Premenopausal endocrine status; pregnant or lactating females.

- Usage of an investigational drug within thirty (30) days prior to enrollment; or the planned usage of an investigational drug other than the study medication during the course of the current study.

- Contraindication to use of toremifene, atamestane, letrozole, or any of the inactive components of their formulations as stated in the investigators brochure or product package insert.

- Patients who are unable to comply with the study requirements or diagnostic procedures.

- Prior enrollment in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Atamestane

Toremifene

Letrozole

Aromatase inhibition

Estrogen receptor blocker

Procedure:
Hormone therapy

Endocrine therapy

Antiestrogen therapy


Locations

Country Name City State
Bulgaria Research Site Blagoevgrad
Bulgaria Research Site Plovdiv
Bulgaria Research Site Shumen
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Stara Zagora
Bulgaria Research Site Varna
Romania Research Site Arad
Romania Research Site Brasov
Romania Research Site Bucharest
Romania Research Site Bucharest
Romania Research Site Cluj-Napoca
Romania Research Site Oradea
Romania Research Site Ploiesti
Romania Research Site Targu-Mures
Romania Research Site Timisoara
Russian Federation Research Site Arkhanglsk
Russian Federation Research Site Astrakhan
Russian Federation Research Site Chelyabinsk
Russian Federation Research Site Engels
Russian Federation Research Site Irkutsk
Russian Federation Research Site Kaliningrad
Russian Federation Research Site Kaluga
Russian Federation Research Site Kazan
Russian Federation Research site Krasnodar
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Omsk
Russian Federation Research Site Orel
Russian Federation Research Site Orenburg
Russian Federation Research Site Perm
Russian Federation Research Site Pyatigorsk
Russian Federation Research Site Sochi
Russian Federation Research Site St. Petersburg
Russian Federation Research Site St. Petersburg
Russian Federation Research Site St. Petersburg
Russian Federation Research Site Syktyvkar
Russian Federation Research Site Tambov
Russian Federation Research Site Ufa
Russian Federation Research Site Ulyanovsk
Russian Federation Research Site Yaroslavl
Ukraine Research Site Chernigov
Ukraine Research Site Chernivtsy
Ukraine Research Site Donetsk
Ukraine Research Site Kharkov
Ukraine Research Site Kherson
Ukraine Research Site Khmelnitsky
Ukraine Research Site Lugansk
Ukraine Research Site Lutsk
Ukraine Research Site Lviv
Ukraine Research Site Mariupol
Ukraine Research Site Odessa
Ukraine Research Site Sumy
Ukraine Research Site Ternopil
Ukraine Research Site Vinnitsa
United States Research Site Augusta Georgia
United States Research Site Billings Montana
United States Research Site Bristol Tennessee
United States Research Site Cherry Hill New Jersey
United States Research Site Chesapeake Virginia
United States Research Site Columbia South Carolina
United States Research Site Danville Virginia
United States Research Site Detroit Michigan
United States Research Site Evansville Indiana
United States Research Site Flint Michigan
United States Research Site Fountain Valley California
United States Research Site Fresh Meadows New York
United States Research Site Greenbrae California
United States Research Site Greenwich Connecticut
United States Research Site Hot Springs Arkansas
United States Research Site Houston Texas
United States Research Site Jacksonville Florida
United States Research Site Kissimmee Florida
United States Research Site Lacey Washington
United States Research Site Lenexa Kansas
United States Research Site Los Angeles California
United States Research Site Louisville Kentucky
United States Research Site Memphis Tennessee
United States Research Site Miami Florida
United States Research Site Milwaukee Wisconsin
United States Research Site Mobile Alabama
United States Research Site New Albany Indiana
United States Research Site Newark New Jersey
United States Research Site Norfolk Virginia
United States Research Site Ocala Florida
United States Research Site Ogden Utah
United States Research Site Pasadena Texas
United States Research Site Pembroke Pines Florida
United States Research Site Philadelphia Pennsylvania
United States Research Site Poway California
United States Research Site Racine Wisconsin
United States Research Site Reno Nevada
United States Research Site Rhinelander Wisconsin
United States Research Site Robbinsdale Minnesota
United States Research Site Savannah Georgia
United States Research Site Shreveport Louisiana
United States Research Site St. Louis Missouri
United States Research Site Tampa Florida
United States Research Site Towson Maryland
United States Research Site Tuscon Arizona
United States Research Site Valhalla New York
United States Research Site West Reading Pennsylvania
United States Research Site Wooster Ohio
United States Research Site Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
Intarcia Therapeutics

Countries where clinical trial is conducted

United States,  Bulgaria,  Romania,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to progression
Secondary Response rate
Secondary Safety
Secondary Overall survival
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