CLINICAL TRIALS PROFILE FOR FARESTON
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All Clinical Trials for FARESTON
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00044291 ↗ | Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer | Completed | Intarcia Therapeutics | Phase 3 | 2002-06-01 | 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. |
| NCT00097344 ↗ | The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer | Terminated | Intarcia Therapeutics | Phase 3 | 2004-12-01 | 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. |
| NCT00267553 ↗ | Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer | Terminated | Intarcia Therapeutics | Phase 3 | 2005-11-01 | 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. |
| NCT00437359 ↗ | Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer | Terminated | Japan Breast Cancer Research Network | Phase 2 | 2007-05-01 | To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast cancer. |
| NCT01352091 ↗ | Adjuvant AI Combined With Zoladex | Unknown status | Fudan University | Phase 3 | 2008-05-01 | The present study is a randomized open-label -phase III study that aims to compare the efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years for premenopausal breast cancer women with hormone receptor positive, lymph node positive or tumor ≥4cm. According to St. Gallen's guideline, hormone receptor positive was defined as endocrine responsive and endocrine response uncertain categories (table 3-1), and only those with ER or PR expression undetectable were considered as HR negative. The pathological evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or directly through ALND when axillary nodes appeared to be positive in clinical examination. Based on the operating standard of local medical institution, identifying the numbers of lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station nodes accurately. |
| NCT02097459 ↗ | Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer | Recruiting | Peking Union Medical College Hospital | Phase 3 | 2014-03-01 | It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer. |
| NCT02344940 ↗ | Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer | Completed | Shanghai Jiao Tong University School of Medicine | Phase 4 | 2014-12-01 | To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms. |
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