Breast Neoplasms Clinical Trial
Official title:
Phase 3 Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Intarcia Therapeutics |
United States, Bulgaria, Romania, Russian Federation, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to progression | |||
Secondary | Response rate | |||
Secondary | Safety | |||
Secondary | Overall survival |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT03664778 -
Abbreviated Breast MRI After Cancer Treatment
|
||
Recruiting |
NCT03144622 -
18F-FSPG PET/CT Imaging in Patients With Cancers
|
||
Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
Active, not recruiting |
NCT04568902 -
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT02860585 -
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03698942 -
Delphinus SoftVueâ„¢ ROC Reader Study
|
||
Completed |
NCT00092950 -
Exercise in Women at Risk for Breast Cancer
|
Phase 2 | |
Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02151071 -
The Breast Surgery EnLight and LightPath Imaging System Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT02934360 -
TR(ACE) Assay Clinical Specimen Study
|
N/A | |
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
N/A | |
Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A |