Breast NeoplasmPhase 2STEMNCT02970682
SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer
A Phase 2 study testing SFX-01, Fulvestrant and Tamoxifen in people with Breast Neoplasm, run by Evgen Pharma at 10 sites in 4 countries.
Trial summary
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant. Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- SFX-01, Fulvestrant and Tamoxifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Oct 2016to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients 18 years or older (the patient must be the legal age limit to give informed consent within the jurisdiction the study is taking place in);
- Patients with histologically confirmed estrogen receptor positive (ER+) breast cancer. ER is considered positive if a percentage score of ≥10% of tumour cells staining positive for ER;
- Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis or on biopsy of a metastasis. HER2 negative is defined by the ASCO/CAP guidelines;
- Patients with clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection;
- Patients must have at least one site of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) ≥ 10 mm with spiral CT scan or MRI scan (malignant lymph nodes should be ≥15mm to be considered measurable); all sites of disease should be noted and followed in accordance with RECIST v1.1. (A lytic or mixed lytic-blastic bone lesion with a soft tissue component assessed on CT/MRI can be measurable if the minimum size criteria are met. Blastic bone lesions and bone lesions assessed on bone scan, positron emission therapy (PET) or plain films are non-measurable);
- Patients must have an anticipated life expectancy of at least 12 weeks;
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- Adequate bone marrow, renal and hepatic function defined as:
- Haemoglobin > 9 g/dL;
- Absolute neutrophil count > 1.0 x 109/L;
- Platelets > 100 x 109/L;
- Total bilirubin within normal limits, except those with Gilberts syndrome for whom this must be <2.5 x ULN;
- AST(SGOT) or ALT(SGPT) < 2.5 x ULN;
- Calculated creatinine clearance > 30 ml/min (Appendix 2);
- Eastern Cooperative Oncology Group (ECOG) performance status < 2;
- Must currently be on either a third generation aromatase inhibitor, tamoxifen or fulvestrant and have a documented evidence of progressive disease after:
- taking ET as adjuvant therapy for >2 years or
- achieving a best response of stable disease (for at least 6 months) or an objective response of CR or PR on the current treatment both indicating the development of secondary resistance to current therapy;
- Suitable for continuing endocrine therapy according to the treating clinician. The window of discontinuation must not exceed 4 weeks.
- All patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- No more than 3 lines of endocrine therapy for metastatic/locally advanced breast cancer including the treatment that the patient is receiving at the time of study entry. This can include targeted agents alongside endocrine therapy such as, but not limited to, everolimus and palbociclib. Ovarian function suppression therapy is not an exclusion for females who are premenopausal and on an ET that can be continued throughout the study.
- No more than one prior line of chemotherapy/targeted therapy for metastatic/locally advanced breast cancer.
- Patients with adequately controlled hepatitis C or hepatitis B surface antigen.
- No residual toxicity > grade 1 from prior antineoplastic therapy with the exception of peripheral neuropathy or neuropathic pain which must be stable (as per investigator assessment);
- Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control (e.g., barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices) during the entire duration of the study and for 6 months after final administration of study drug. Note that sterility in female patients must be confirmed in the patients' medical records and be defined as any of the following: surgical hysterectomy or bilateral oophorectomy, bilateral tubular ligation, natural menopause with last menses >1 year ago; radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with 1 year interval since last menses; male patients whose female partner(s) is (are) pregnant must use a condom from the time of the first administration of SFX-01 until 3 months following administration of last dose;
- Female patients of childbearing potential must have a negative serum or urine pregnancy test at day 1 of the study.
Who cannot join
- Rapidly progressive visceral disease not suitable for further endocrine therapy;
- Currently on chemotherapy or any other combination treatment for their MBC other than AI, tamoxifen or fulvestrant;
- Radiotherapy less than 2 weeks prior to study entry;
- Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment;
- Spinal cord compression or brain metastases unless treated and radiologically stable for > 6weeks post treatment and not requiring steroids for at least 4 weeks prior to start of study treatment;
- As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required;
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- Refractory nausea and vomiting, patients with malabsorption syndrome, diseases significantly affecting gastrointestinal function, resection of the stomach or small bowel, or difficulty in swallowing and retaining oral medications;
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures;
- Patients with unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment;
- Diagnosed or treated for a malignancy other than breast cancer within 1 year, or who were previously diagnosed with a malignancy other than breast cancer and have any radiographic or biochemical marker evidence of malignancy. Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy (other than breast) are not excluded.
- Concurrent treatment with another investigational agent or participated in another investigational trial unless adequate washout period per the investigational drug PK has been achieved (usually this is 5 half lives of a product);
- Females who are pregnant, wishing to become pregnant or breast feeding.
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation
Birmingham, B15 2TH
Royal Bournemouth & Christchurch Hospitals NHS
Bournemouth, BH7 7DW
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
Academic unit of Clinical Oncology
Sheffield, S10 2SJ
Royal Albert & Edward Infirmary
Wigan, WN1 2WN
Belgium2 sites
Grand Hopital de Charleroi, Service D'Oncologie-Hematologie
Charleroi, 6000
Saint-Luc hospital, Brussels
Woluwe-Saint-Lambert, 1200
Spain2 sites
Granollers Hospital, Granollers,
Barcelona
Hospital Universitario Ramon Y Cajal
Madrid, 100
About this study
Official title: STEM: A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients With Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on Either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.
Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy.
Read the detailed description
The trial is a phase 2, parallel group design in patients with ER positive metastatic breast cancer.
This study will be a multicentre study conducted over an 18 month period. Patients who are taking either a third generation AI, tamoxifen or fulvestrant and have a documented evidence of progressive disease after achieving a best response of stable disease (for at least 6 months) or an objective response of CR or PR on the current treatment indicating the development of secondary resistance to current therapy will be entered into the study having undergone a screening period to continue receiving the same treatment with the addition of SFX-01.
At least 60 patients will be enrolled into one of three arms in a 1:1:1 ratio, i.e. 20 patients per arm. Enrolment will be based on current treatment.
Treatment Arm A: All patients will continue to receive their AI and, at the start of the study (D1), patients will additionally take SFX-01.
Treatment Arm B: All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will additionally take SFX-01
Treatment Arm C: All patients will continue to receive fulvestrant 500 mg IM in 28 day Cycles and, at the start of the study (D1), patients will additionally take SFX-01.
Patient participation will include a Screening Phase, a Treatment Phase, and a Follow-up Phase of up to 28 weeks post D1 of dosing. The Screening Phase will be up to 28 days prior to enrolment. The Treatment Phase will extend from enrolment until the patient is discontinued from study treatment. The Follow-up Phase will be a maximum of 28 weeks and extend from the time of study entry until 30 days after the patient discontinues trial therapy.
- Conditions
- Breast Neoplasm
- Being tested
- SFX-01, Fulvestrant, Tamoxifen, Aromatase Inhibitors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SFX-01Drug
Also called Sulforadex
Stabilised Sulforaphane
FulvestrantDrug
Fulvestrant
TamoxifenDrug
Tamoxifen
Aromatase InhibitorsDrug
| Study group | Role | What they receive |
|---|---|---|
| Aromatase Inhibitor | Experimental | SFX-01 with Aromatase Inhibitor SFX-01 when used in combination with aromatase inhibitors. All patients will continue to receive their AI and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours). Receives: Drug: SFX-01; Drug: Aromatase Inhibitors |
| Fulvestrant | Experimental | SFX-01 with Fulvestrant SFX-01 when used in combination with fulvestrant. All patients will continue to receive fulvestrant 500 mg IM in 28 day cycles. As patients will already have been taking this, a repeat loading dose is not necessary. Commencing on study D1 patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours). Receives: Drug: SFX-01; Drug: Fulvestrant |
| Tamoxifen | Experimental | SFX-01 with Tamoxifen SFX-01 when used in combination with tamoxifen All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart after food (preferably within 2 hours). Receives: Drug: SFX-01; Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Emergent Adverse Events [Safety and Tolerability])
To determine the safety and tolerability of SFX-01 in combination with AI, tamoxifen and fulvestrant
Measured: 28 weeks
Clinical benefit rate
To determine clinical benefit rate (CBR) (CR+PR+SD) at 24 weeks using RECIST v1.1
Measured: 24 weeks
Secondary outcomes (7)
Objective Response rate
To determine objective response rate (ORR) (CR+PR) at 24 weeks using RECIST v1.1
Measured: 24 Weeks
Time To Response
To determine time to response
Measured: 24 weeks
Time to Progression
To determine time to progression (TTP)
Measured: 24 Weeks
Progression Free Survival
To determine progression free survival (PFS) at 24 weeks
Measured: 24 Weeks
Overall Survival
To determine overall survival (OS) at 24 weeks
Measured: 24 Weeks
Clinical Benefit
To determine clinical benefit by measuring duration of response compared to duration of response to prior ET
Measured: 24 Weeks
Time to next Treatment
To determine time to next treatment
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evgen Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Sacha Howell, MD PhD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970682
- Sponsor's protocol ID
- EVG001BC
- Acronym
- STEM
- Status last verified
- Jun 2019
- First submitted
- 15 Nov 2016
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEM: A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients With Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on Either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant
- ClinicalTrials.gov ID
- NCT02970682
- Acronym / sponsor ID
- STEM / EVG001BC
- Conditions
- Breast Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Evgen PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 22 Nov 2016 (estimated)
- 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 a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.
Patients will be enrolled into one of three study arms (SFX-01 in combination with AI, tamoxifen or fulvestrant) based on their current therapy.
Detailed description
The trial is a phase 2, parallel group design in patients with ER positive metastatic breast cancer.
This study will be a multicentre study conducted over an 18 month period. Patients who are taking either a third generation AI, tamoxifen or fulvestrant and have a documented evidence of progressive disease after achieving a best response of stable disease (for at least 6 months) or an objective response of CR or PR on the current treatment indicating the development of secondary resistance to current therapy will be entered into the study having undergone a screening period to continue receiving the same treatment with the addition of SFX-01.
At least 60 patients will be enrolled into one of three arms in a 1:1:1 ratio, i.e. 20 patients per arm. Enrolment will be based on current treatment.
Treatment Arm A: All patients will continue to receive their AI and, at the start of the study (D1), patients will additionally take SFX-01.
Treatment Arm B: All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will additionally take SFX-01
Treatment Arm C: All patients will continue to receive fulvestrant 500 mg IM in 28 day Cycles and, at the start of the study (D1), patients will additionally take SFX-01.
Patient participation will include a Screening Phase, a Treatment Phase, and a Follow-up Phase of up to 28 weeks post D1 of dosing. The Screening Phase will be up to 28 days prior to enrolment. The Treatment Phase will extend from enrolment until the patient is discontinued from study treatment. The Follow-up Phase will be a maximum of 28 weeks and extend from the time of study entry until 30 days after the patient discontinues trial therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aromatase Inhibitor | Experimental | Drug: SFX-01, Drug: Aromatase InhibitorsSFX-01 with Aromatase Inhibitor SFX-01 when used in combination with aromatase inhibitors. All patients will continue to receive their AI and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours). |
| Fulvestrant | Experimental | Drug: SFX-01, Drug: FulvestrantSFX-01 with Fulvestrant SFX-01 when used in combination with fulvestrant. All patients will continue to receive fulvestrant 500 mg IM in 28 day cycles. As patients will already have been taking this, a repeat loading dose is not necessary. Commencing on study D1 patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours). |
| Tamoxifen | Experimental | Drug: SFX-01, Drug: TamoxifenSFX-01 with Tamoxifen SFX-01 when used in combination with tamoxifen All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart after food (preferably within 2 hours). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male or female patients 18 years or older (the patient must be the legal age limit to give informed consent within the jurisdiction the study is taking place in);
- Patients with histologically confirmed estrogen receptor positive (ER+) breast cancer. ER is considered positive if a percentage score of ≥10% of tumour cells staining positive for ER;
- Histological confirmation of HER2 negative breast cancer on primary tumour at diagnosis or on biopsy of a metastasis. HER2 negative is defined by the ASCO/CAP guidelines;
- Patients with clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection;
- Patients must have at least one site of measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) ≥ 10 mm with spiral CT scan or MRI scan (malignant lymph nodes should be ≥15mm to be considered measurable); all sites of disease should be noted and followed in accordance with RECIST v1.1. (A lytic or mixed lytic-blastic bone lesion with a soft tissue component assessed on CT/MRI can be measurable if the minimum size criteria are met. Blastic bone lesions and bone lesions assessed on bone scan, positron emission therapy (PET) or plain films are non-measurable);
Key exclusion criteria (12 listed)
- Rapidly progressive visceral disease not suitable for further endocrine therapy;
- Currently on chemotherapy or any other combination treatment for their MBC other than AI, tamoxifen or fulvestrant;
- Radiotherapy less than 2 weeks prior to study entry;
- Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment;
- Spinal cord compression or brain metastases unless treated and radiologically stable for > 6weeks post treatment and not requiring steroids for at least 4 weeks prior to start of study treatment;
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 |
|---|---|---|
| SFX-01Also: SulforadexStabilised Sulforaphane | Drug | Aromatase Inhibitor, Fulvestrant, Tamoxifen |
| FulvestrantFulvestrant | Drug | Fulvestrant |
| TamoxifenTamoxifen | Drug | Tamoxifen |
| Aromatase Inhibitors | Drug | Aromatase Inhibitor |
Primary outcome
Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: 28 weeks
To determine the safety and tolerability of SFX-01 in combination with AI, tamoxifen and fulvestrant
Clinical benefit rate
Time frame: 24 weeks
To determine clinical benefit rate (CBR) (CR+PR+SD) at 24 weeks using RECIST v1.1
7 secondary outcomes
Objective Response rate
Time frame: 24 Weeks
Time To Response
Time frame: 24 weeks
Time to Progression
Time frame: 24 Weeks
Progression Free Survival
Time frame: 24 Weeks
Overall Survival
Time frame: 24 Weeks
Clinical Benefit
Time frame: 24 Weeks
Time to next Treatment
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Sacha Howell, MD PhD principal investigator
The Christie NHS Foundation Trust
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SFX-01, Fulvestrant and Tamoxifen in people with Breast Neoplasm, run by Evgen Pharma at 10 sites in 4 countries.
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 25 inclusion and 12 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: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom, Belgium, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Emergent Adverse Events [Safety and Tolerability]) (time frame: 28 weeks). The study lists 2 primary outcomes in all. 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 12 Jul 2019.