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Last Updated: January 20, 2020

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CLINICAL TRIALS PROFILE FOR FULVESTRANT

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505(b)(2) Clinical Trials for Fulvestrant

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT00099437 Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy. Active, not recruiting AstraZeneca Phase 3 2005-02-01 The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment.
New Dosage NCT01300351 Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women Completed AstraZeneca Phase 3 2011-03-01 The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.
New Combination NCT03344536 A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer Recruiting Debiopharm International SA Phase 1/Phase 2 2017-11-10 The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a medication or combination of medications. Therefore, the purpose of this study is to decide the best dose of the study drug, Debio 1347, that can be given in combination with the standard hormonal drug, fulvestrant. Debio 1347 and fulvestrant could shrink the cancer but it could also cause side effects. This study tells us about the side effects of these drugs when given in this new combination, and how often they occur.
New Combination NCT03344536 A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer Recruiting Memorial Sloan Kettering Cancer Center Phase 1/Phase 2 2017-11-10 The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a medication or combination of medications. Therefore, the purpose of this study is to decide the best dose of the study drug, Debio 1347, that can be given in combination with the standard hormonal drug, fulvestrant. Debio 1347 and fulvestrant could shrink the cancer but it could also cause side effects. This study tells us about the side effects of these drugs when given in this new combination, and how often they occur.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fulvestrant

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00006903 Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer Active, not recruiting AstraZeneca Phase 2 2004-08-01 RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer.
NCT00006903 Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer Active, not recruiting National Cancer Institute (NCI) Phase 2 2004-08-01 RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer.
NCT00006903 Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer Active, not recruiting Gynecologic Oncology Group Phase 2 2004-08-01 RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells. PURPOSE: This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer.
NCT00010153 ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer Terminated Breast International Group Phase 3 2000-11-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases. PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.
NCT00010153 ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer Terminated European Organisation for Research and Treatment of Cancer - EORTC Phase 3 2000-11-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases. PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.
NCT00012025 ICI 182780 in Treating Women With Metastatic Breast Cancer Completed National Cancer Institute (NCI) Phase 2 2001-05-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells. PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.
NCT00012025 ICI 182780 in Treating Women With Metastatic Breast Cancer Completed Alliance for Clinical Trials in Oncology Phase 2 2001-05-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells. PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fulvestrant

Condition Name

Condition Name for Fulvestrant
Intervention Trials
Breast Cancer 82
Metastatic Breast Cancer 46
Breast Neoplasms 16
Advanced Breast Cancer 11
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Condition MeSH

Condition MeSH for Fulvestrant
Intervention Trials
Breast Neoplasms 198
Neoplasms 11
Carcinoma 11
Carcinoma, Non-Small-Cell Lung 6
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Clinical Trial Locations for Fulvestrant

Trials by Country

Trials by Country for Fulvestrant
Location Trials
United States 904
Italy 154
Spain 103
Canada 80
Japan 58
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Trials by US State

Trials by US State for Fulvestrant
Location Trials
California 48
New York 46
Florida 44
Texas 44
Massachusetts 40
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Clinical Trial Progress for Fulvestrant

Clinical Trial Phase

Clinical Trial Phase for Fulvestrant
Clinical Trial Phase Trials
Phase 4 6
Phase 3 39
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Fulvestrant
Clinical Trial Phase Trials
Recruiting 77
Not yet recruiting 47
Active, not recruiting 43
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Clinical Trial Sponsors for Fulvestrant

Sponsor Name

Sponsor Name for Fulvestrant
Sponsor Trials
AstraZeneca 54
National Cancer Institute (NCI) 20
Pfizer 18
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Sponsor Type

Sponsor Type for Fulvestrant
Sponsor Trials
Other 195
Industry 168
NIH 21
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