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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00044291
Other study ID # Biomed 777-CLP-29
Secondary ID
Status Completed
Phase Phase 3
First received August 23, 2002
Last updated July 29, 2015
Start date June 2002
Est. completion date January 2006

Study information

Verified date July 2015
Source Intarcia Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the first line combination hormonal therapy 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 in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.


Description:

Breast cancer cells are often very dependent on estrogens to continue to grow. Atamestane blocks the formation of estrogens and androgenic precursors in the body. 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 maximal suppression of estrogen stimulation of breast cancer cells. This study is designed to determine whether combination therapy will lengthen the time to disease progression and the rate of objective response compared to single agent aromatase inhibitor therapy with letrozole.


Recruitment information / eligibility

Status Completed
Enrollment 865
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Women age 18 years or older

- Pathological or histological confirmation of breast cancer at initial diagnosis or at the time of metastases

- 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

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

- At least one tumor localization measurable in 2 dimensions (one diameter at least 2 cm for soft tissue/visceral disease assessed by CT/MRI scan or conventional X-ray technique, 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 initial diagnosis or determined during subsequent biopsy/surgery of metastases

- Written informed consent obtained

Exclusion Criteria:

- Prior hormonal therapy to treat locally recurrent, locally advanced or metastatic disease

- Prior adjuvant therapy with aromatase inhibitors or antiestrogens/SERMs within 12 months prior to enrollment

- Progression of disease during therapy with antiestrogens (including SERMs administered for prevention of osteoporosis)

- Life-threatening locally recurrent, locally advanced or metastatic disease or disease requiring chemotherapeutic intervention (such as inflammatory breast cancer)

- 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 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 the 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

- 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

Procedure:
hormone therapy

endocrine therapy

antiestrogen therapy


Locations

Country Name City State
Canada McGill University, Department of Oncology Montreal Quebec
Canada Ottawa Regional Cancer Centre Ottawa Ontario
Canada Northwestern Ontario Regional Cancer Centre Thunder Bay Ontario
Canada Princess Margaret Hospital Toronto Ontario
Russian Federation Arkhangelsk Regional Oncology Center, Department of Chemotherapy Arkhangelsk
Russian Federation Tatarstan Republican Clinical Oncology Center Kazan
Russian Federation Krasnodar Regional Clinical Oncology Center, Chemotherapy Department Krasnodar
Russian Federation Leningrad Regional Oncology Center Leningrad
Russian Federation Lipetsk Regional Oncology Center, Department of General Oncology Lipetsk
Russian Federation Blokhin Cancer Research Center, Department of Chemotherapy Moscow
Russian Federation Blokhin Cancer Research Center, Department of Chemotherapy and Combined Treatment of Tumors Moscow
Russian Federation Blokhin Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy Moscow
Russian Federation Blokhin Cancer Research Center, Department of New Antitumor Drug Research Moscow
Russian Federation Central Clinical Hospital of the Ministry of Transport n.a. Semashko, Department of Chemotherapy Moscow
Russian Federation Hertzen Research Institute of Oncology, Department of Chemotherapy Moscow
Russian Federation Moscow City Hospital #40, Department of Chemotherapy Moscow
Russian Federation Moscow City Oncology Hospital #62 Moscow
Russian Federation Murmansk Regional Oncology Center Murmansk
Russian Federation Municipal Clinical Hospital #1, Department of Breast Tumors, Oncology Department Novosibirsk
Russian Federation Medical Radiological Research Center Obninsk
Russian Federation Ryazan Regional Clinical Oncology Center Ryazan
Russian Federation Samara Regional Oncology Center, Department of Chemotherapy Samara
Russian Federation Laboratory of Thoracic Oncology, St. Petersburg Pavlov State Medical University, Research Institute of Pulmonology St. Petersburg
Russian Federation Petrov Research Institute of Oncology, Department of Biotherapy and Bone Marrow Transplantation St. Petersburg
Russian Federation Petrov Research Institute of Oncology, Department of Breast Cancer St. Petersburg
Russian Federation Petrov Research Institute of Oncology, Department of Chemotherapy St. Petersburg
Russian Federation St. Petersburg City Oncology Center St. Petersburg
Russian Federation Stavropol Regional Oncology Center, Department of Chemotherapy Stavropol
Russian Federation Research Institute of Oncology, Tomsk Scientific Center, Siberian Department of the Russian Academy of Medical Sciences, Department of Chemotherapy Tomsk
Russian Federation V. Novgorod Regional Oncology Center, Department of Chemotherapy V. Novgorod
Russian Federation Burdenko Voronezh Medical Academy, Oncology Department, Clinical Facility: Regional Clinical Oncology Center Voronezh
Ukraine Cherkassy Regional Oncology Center, Chemotherapy Department Cherkassy
Ukraine Dnepropetrovsk State Medical Academy, Oncology Department. Clinical Facility: Dnepropetrovsk City Clinical Hospital #4 Dnepropetrovsk
Ukraine Donetsk State Medical University. Clinical Facility: Donetsk Regional Antineoplastic Center, Mammology Department Donetsk
Ukraine Ivano-Frankovsk State Medical Academy; Oncology Department Clinical Facility: Ivano-Frankovsk Regional Oncology Center Ivano-Frankovsk
Ukraine Kharkov Medical Academy of Postgraduate Education, Oncology and Pediatric Oncology Department. Clinical Facility: Kharkov Regional Clinical Oncology Dispensary, Chemotherapy Department Kharkov
Ukraine Kharkov State Medical University. Clinical Facility: Grigoriev Medical Radiology Institute, Chemotherapy Department Kharkov
Ukraine Kiev Central Clinical Hospital, Ukraine Security Services, Surgery Department Kiev
Ukraine Kiev Oncology Institute, Ukraine Medical Science Academy, Department of Breast Tumors Kiev
Ukraine Kiev Postgraduate Studies Medical Academy. Clinical Facility: Kiev City Oncology Hospital, Chemotherapy Department Kiev
Ukraine National Medical University, Oncology Department. Clinical Facility: Kiev City Oncology Hospital, Surgery Department Kiev
Ukraine Krivoy Rog City Oncology Center Krivoy Rog
Ukraine Lviv State Medical University, Oncology and Medical Radiology Department. Clinical Facility: Lviv State Oncology Regional Clinical Diagnostic Center, Chemotherapy Department Lviv
Ukraine Odessa State Medical University, Oncology Department. Clinical Facility: Odessa Regional Oncology Center, Chemotherapy Department Odessa
Ukraine Uzhgorod National University Oncology Course of Surgery Department of Postgraduate Education Faculty Clinical Facility: Zakarpatye Regional Oncology Center Uzhgorod
Ukraine Zaporozhye Statue Institute of Postgraduate Training. Oncology Department; Clinical Facility: Zaporozhye Regional Oncology Center Zaporozhye
United States Maryland Hematology/Oncology Associates Baltimore Maryland
United States Hematology Oncology Consultants, Inc. Columbus Ohio
United States Great Falls Clinic-Oncology West Great Falls Montana
United States California Cancer Care, Inc. Greenbrae California
United States Oncology Consultants Houston Texas
United States Kansas City Oncology and Hematology Group Kansas City Missouri
United States First Dynamic Healthcare Services, Inc. Killeen Texas
United States Midwest Internal Medicine, PLLC Lake Havasu City Arizona
United States Cache Valley Cancer Treatment & Research Clinic Logan Utah
United States Innovative Medical Research of South Florida Inc. Miami Shores Florida
United States Slocum-Dickson Medical Group New Hartford New York
United States Virginia Oncology Associates Norfolk Virginia
United States Western Washington Oncology Inc., P.S. Olympia Washington
United States Sharp Memorial Hospital San Diego California
United States Oncology Care Associates, PLLC St. Joseph Michigan
United States Georgia Cancer Specialists Tucker Georgia
United States Arizona Clinical Research Center Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
Intarcia Therapeutics

Countries where clinical trial is conducted

United States,  Canada,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to tumor progression time from randomization to first occurrence of tumor progression, assessed at week 12 and every subsequent 12 weeks for patients continuing in the study for up to approximately 36 months No
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