The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03202862|
Recruitment Status : Unknown
Verified June 2017 by Zhimin Shao, Fudan University.
Recruitment status was: Not yet recruiting
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
This is an open-label, single arm, phase II trial to evaluate the efficacy and safety of 500mg Fulvestrant (Faslodex®) in ESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy. Fifty patients will be enrolled and treated with 500 mg Fulvestrant until disease progression or study closed.
Treatment will continue until disease progression, unless any of the criteria for treatment discontinuation are met first. If a patient progresses during the treatment period, the patient must be withdrawn from the treatment and further treatment will be at the investigator's discretion.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Fulvestrant||Phase 2|
All patients will be followed up for disease progression, regardless of whether they have discontinued treatment, unless they have withdrawn consent.
Efficacy will be determined based on tumor assessments performed by each investigator according to RECIST 1.1. Safety will be monitored based on the frequency and severity of adverse events (AEs), as assessed by Common Terminology Criteria (CTC) grade version 4.0.
Tumor assessments will be assessed by computed tomography (CT) or magnetic resonance imaging (MRI) or X ray if necessary every 12 weeks for all patients until documented evidence of objective disease progression.
Reporting of SAEs to regulatory authorities will be done by the investigator in accordance with CFDA regulations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single Arm, Phase II Trial to Evaluate the Efficacy of 500mg Fulvestrant (Faslodex) in ESR1 Mutated Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer After Previous Aromatase Inhibitor Treatment|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||June 1, 2019|
|Estimated Study Completion Date :||August 1, 2019|
Experimental: ESR1 mutated
ESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy
Fulvestrant 500 mg given as two 5 ml intramuscular inections, one in each buttoc, on days 1, 15, 2 and every 2 ( ) days thereafter.
- Tumour assessment [ Time Frame: An average of 5 years, up to 10 years. ]The study will be closed at all the patients progressed or 12 months after the last patient has been recruited depends on which one met first. From date of the first recruitment until the date of all the patients progressed or 12 months after the last patient has been recruited, whichever came first, assessed up to 10 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03202862
|Contact: Zhimin Shaofirstname.lastname@example.org|
|Contact: Yizhou Jiangemail@example.com|