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The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Zhimin Shao, Fudan University

Tracking Information
First Submitted Date  ICMJE June 25, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date June 29, 2017
Estimated Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Drug: Fulvestrant
Fulvestrant 500 mg given as two 5 ml intramuscular inections, one in each buttoc, on days 1, 15, 2 and every 2 ( ) days thereafter.
Study Arms  ICMJE Experimental: ESR1 mutated
ESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy
Intervention: Drug: Fulvestrant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 27, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent document on file.
  2. Postmenopausal woman, defined as a woman fulfilling any of the following criteria:

    • Having undergone a bilateral oophorectomy;
    • Age ≥60 years;
    • Age <60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH (follicle stimulating hormone) and oestradiol level in the postmenopausal range (utilizing ranges from the local laboratory facility);
    • If taking tamoxifen or toremifene, and age < 60 years, then FSH and plasma oestradiol level in the postmenopausal ranges (utilizing ranges from the local laboratory facility).
  3. Histological/cytological confirmation of advanced breast cancer or inoperable locally advanced disease and documented positive oestrogen receptor status, ER (Estrogen Receptor) positive and/or PgR (Progesterone Receptor) positive of primary or metastatic tumour tissue, according to the local laboratory parameters.
  4. Relapsed or progressed during prior treatment with aromatase inhibitor, meeting either of the following criteria:

    • Relapsing during, or after of completion of adjuvant aromatase inhibitors therapy, i.e. anastrozole, letrozole, exemestane. Duration of adjuvant aromatase inhibitors treatment should be at least 2 years.
    • Progressing on at least 6 months first line aromatase inhibitors therapy for advanced disease
  5. Metastatic disease must be measurable or evaluable. Patients fulfilling one of the following criteria:

    • Patients with measurable disease as per RECIST 1.1 criteria.
    • Patients with bone lesions, lytic or mixed (lytic + sclerotic), which had not been previously irradiated, in the absence of measurable disease as defined by RECIST 1.1 criteria.
  6. The blood sample is clarified to be ESR1 mutated, The mutation should be: Y537C, Y537N, Y537S, S463P and D538G.
  7. ECOG performance status 0,1.
  8. Patients with life expectancy of more than 3 months.

Exclusion Criteria:

  1. Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not compromised as a result of disease.
  2. Previous systemic chemotherapy for advanced breast cancer.
  3. Received endocrine therapy for advanced breast cancer > 1 lines;
  4. Extensive radiation therapy within the last 4 weeks (greater than or equal to 30% marrow or whole pelvis or spine) or cytotoxic treatment within the past 4 weeks prior to screening laboratory assessment, or strontium-90 (or other radiopharmaceuticals) within the past 3 months.
  5. Prior treatment with Fulvestrant.
  6. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC)3+ positive or fluorescence in situ hybridisation (FISH) positive, where appropriate
  7. Treatment with a non-approved or experimental drug within 4 weeks.
  8. Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix)
  9. Any of the following laboratory values :

    • Platelets < 100 10^9 / L
    • Total bilirubin >1.5 ULRR
    • ALT( Alanine transaminase) or AST(Aspartate transaminase)>2.5 ULRR if no demonstrable liver metastases or > 5 ULRR in presence of liver metastases
    • Severe renal impairment (creatinine clearance < 30ml/min)
  10. History of:

    •bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency), or long-term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin).

  11. History of hypersensitivity to active or inactive excipients of Fulvestrant and castor oil.

Any severe concomitant condition which makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the trial protocol. E.g. uncontrolled cardiac disease or uncontrolled diabetes mellitus.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03202862
Other Study ID Numbers  ICMJE Fulvestrant in ESR1 Mutated BC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhimin Shao, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP