SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer (STEM)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02970682|
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : December 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Drug: SFX-01 Drug: Fulvestrant Drug: Tamoxifen Drug: Aromatase Inhibitors||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Aromatase Inhibitor
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).
Other Name: SulforadexDrug: Aromatase Inhibitors
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).
Other Name: SulforadexDrug: Fulvestrant
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).
Other Name: SulforadexDrug: Tamoxifen
- 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
- Objective Response rate [ Time Frame: 24 Weeks ]To determine objective response rate (ORR) (CR+PR) at 24 weeks using RECIST v1.1
- Time To Response [ Time Frame: 24 weeks ]To determine time to response
- Time to Progression [ Time Frame: 24 Weeks ]To determine time to progression (TTP)
- Progression Free Survival [ Time Frame: 24 Weeks ]To determine progression free survival (PFS) at 24 weeks
- Overall Survival [ Time Frame: 24 Weeks ]To determine overall survival (OS) at 24 weeks
- Clinical Benefit [ Time Frame: 24 Weeks ]To determine clinical benefit by measuring duration of response compared to duration of response to prior ET
- Time to next Treatment [ Time Frame: 24 weeks ]To determine time to next treatment
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): NCT02970682
|Contact: David Chadwick, NHSTDI.||+email@example.com|
|Grand Hopital de Charleroi, Service D'Oncologie-Hematologie||Recruiting|
|Charleroi, Belgium, 6000|
|Contact: Jean-Luc Canon, PhD +32 71102111|
|Saint-Luc hospital, Brussels||Recruiting|
|Woluwe-Saint-Lambert, Belgium, 1200|
|Contact: Francois Duhoux, MD PhD +3227645435 firstname.lastname@example.org|
|ICO René Gauducheau, St Herblain||Not yet recruiting|
|Nantes, Loire Atlantique, France, 44805|
|Contact: Mario Campone, MD 02 40 67 99 77 email@example.com|
|Granollers Hospital, Granollers,||Not yet recruiting|
|Contact: Vanessa Ortega,,, MD +34938425000 ext 6052 firstname.lastname@example.org|
|Hospital Universitario Ramon Y Cajal||Recruiting|
|Madrid, Spain, 100|
|Contact: Javier Cortes, Phd +34 913368263 email@example.com|
|The Christie NHS Foundation Trust||Recruiting|
|Manchester, Greater Manchester, United Kingdom, M20 4BX|
|Contact: Sacha Howell, MB BS PhD 44 161 4463000|
|University Hospitals Birmingham NHS Foundation||Not yet recruiting|
|Birmingham, United Kingdom, B15 2TH|
|Contact: Suhail Anwar, PhD +44121 3713575 firstname.lastname@example.org|
|Royal Bournemouth & Christchurch Hospitals NHS||Recruiting|
|Bournemouth, United Kingdom, BH7 7DW|
|Contact: Tamas Hickish, PhD +441202704789 email@example.com|
|Academic unit of Clinical Oncology||Recruiting|
|Sheffield, United Kingdom, S10 2SJ|
|Contact: Janet Brown, PhD|
|Contact: H Shulver +44114 226 5225 H.Shulver@sheffield.ac.uk|
|Royal Albert & Edward Infirmary||Recruiting|
|Wigan, United Kingdom, WN1 2WN|
|Contact: Elena Takeuchi, PhD +441942 244000|
|Principal Investigator:||Sacha Howell, MD PhD||The Christie NHS Foundation Trust|