NCT02970682: STEM

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

Completed Phase 2 Last updated 11 July 2019

What this trial tests

Phase 2 trial testing SFX-01 in Breast Neoplasm in 60 participants. Completed in 1 March 2019.

Timeline

1 October 2016

Primary endpoint
1 January 2019

1 March 2019

Quick facts

Lead sponsor	Evgen Pharma
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 October 2016
Primary completion	1 January 2019
Estimated completion	1 March 2019
Sites	10 locations across Belgium, France, Spain, United Kingdom

Drugs / interventions tested

• SFX-01 — full drug profile →
• Fulvestrant (fulvestrant) — full drug profile →
• Tamoxifen — full drug profile →
• Aromatase Inhibitors (aromatase-inhibitors) — full drug profile →

Conditions studied

• Breast Neoplasm — all drugs for Breast Neoplasm →

Sponsor

Evgen Pharma — full company profile →

Who can join

18 and older, any sex, with Breast Neoplasm. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Activators and Inhibitors of NRF2: A Review of Their Potential for Clinical Development.
   Robledinos-Antón N, Fernández-Ginés R, Manda G, Cuadrado A. · · 2019 · cited 443× · PMID 31396308 · DOI 10.1155/2019/9372182
2. Nrf2 and Heme Oxygenase-1 Involvement in Atherosclerosis Related Oxidative Stress.
   Alonso-Piñeiro JA, Gonzalez-Rovira A, Sánchez-Gomar I, Moreno JA, et al · · 2021 · cited 78× · PMID 34573095 · DOI 10.3390/antiox10091463
3. MicroRNAs and Epigenetics Strategies to Reverse Breast Cancer.
   Rahman MM, Brane AC, Tollefsbol TO. · · 2019 · cited 77× · PMID 31597272 · DOI 10.3390/cells8101214
4. Impaired antioxidant KEAP1-NRF2 system in amyotrophic lateral sclerosis: NRF2 activation as a potential therapeutic strategy.
   Bono S, Feligioni M, Corbo M. · · 2021 · cited 56× · PMID 34663413 · DOI 10.1186/s13024-021-00479-8
5. Role of Nrf2 Signaling Cascade in Breast Cancer: Strategies and Treatment.
   Kumar H, Kumar RM, Bhattacharjee D, Somanna P, et al · · 2022 · cited 48× · PMID 35571115 · DOI 10.3389/fphar.2022.720076
6. Phytochemical-Based Nanomedicine for Advanced Cancer Theranostics: Perspectives on Clinical Trials to Clinical Use.
   Dhupal M, Chowdhury D. · · 2020 · cited 48× · PMID 33244231 · DOI 10.2147/ijn.s259628
7. Understanding the Emerging Link Between Circadian Rhythm, Nrf2 Pathway, and Breast Cancer to Overcome Drug Resistance.
   Bevinakoppamath S, Ramachandra SC, Yadav AK, Basavaraj V, et al · · 2021 · cited 28× · PMID 35126099 · DOI 10.3389/fphar.2021.719631
8. Clinical utility of fulvestrant in the treatment of breast cancer: a report on the emerging clinical evidence.
   Rocca A, Maltoni R, Bravaccini S, Donati C, et al · · 2018 · cited 27× · PMID 30214302 · DOI 10.2147/cmar.s137772