Breast NeoplasmsPhase 2NCT03202862
The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer
A Phase 2 study testing Fulvestrant in people with Breast Neoplasms, run by Fudan University.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Aug 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent document on file.
- 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).
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- 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.
- 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
- 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.
- The blood sample is clarified to be ESR1 mutated, The mutation should be: Y537C, Y537N, Y537S, S463P and D538G.
- ECOG performance status 0,1.
- Patients with life expectancy of more than 3 months.
Who cannot join
- 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.
- Previous systemic chemotherapy for advanced breast cancer.
- Received endocrine therapy for advanced breast cancer > 1 lines;
- 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.
- Prior treatment with Fulvestrant.
- HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC)3+ positive or fluorescence in situ hybridisation (FISH) positive, where appropriate
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- Treatment with a non-approved or experimental drug within 4 weeks.
- 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)
- 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)
- 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).
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Fulvestrant
- Keywords
- fulvestrant, ESR1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
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 group | Role | What they receive |
|---|---|---|
| ESR1 mutated | Experimental | ESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumour assessment
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.
Measured: An average of 5 years, up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202862
- Sponsor's protocol ID
- Fulvestrant in ESR1 Mutated BC
- Status last verified
- Jun 2017
- First submitted
- 25 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03202862
- Acronym / sponsor ID
- Fulvestrant in ESR1 Mutated BC
- Conditions
- Breast Neoplasms
- Keywords
- fulvestrant, ESR1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESR1 mutated | Experimental | Drug: FulvestrantESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Signed informed consent document on file.
- Postmenopausal woman, defined as a woman fulfilling any of the following criteria:
- 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.
- Relapsed or progressed during prior treatment with aromatase inhibitor, meeting either of the following criteria:
- Metastatic disease must be measurable or evaluable. Patients fulfilling one of the following criteria:
Key exclusion criteria (17 listed)
- 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.
- Previous systemic chemotherapy for advanced breast cancer.
- Received endocrine therapy for advanced breast cancer > 1 lines;
- 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.
- Prior treatment with Fulvestrant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestrantFulvestrant 500 mg given as two 5 ml intramuscular inections, one in each buttoc, on days 1, 15, 2 and every 2 ( ) days thereafter. | Drug | ESR1 mutated |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant in people with Breast Neoplasms, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao (+86-021-64175590, zhimingshao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumour assessment (time frame: An average of 5 years, up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2017.