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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02970682
Date of registration: 15/11/2016
Prospective Registration: No
Primary sponsor: Evgen Pharma
Public title: SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer STEM
Scientific 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
Date of first enrolment: October 2016
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02970682
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 2
Countries of recruitment
Belgium Czech Republic France Spain United Kingdom
Contacts
Name:     Sacha Howell, MD PhD
Address: 
Telephone:
Email:
Affiliation:  The Christie NHS Foundation Trust
Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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);

2. 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;

3. 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;

4. Patients with clinical or histological confirmation of metastatic or locally advanced
disease not amenable to curative surgical resection;

5. 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);

6. Patients must have an anticipated life expectancy of at least 12 weeks;

7. 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);

8. Eastern Cooperative Oncology Group (ECOG) performance status < 2;

9. Must currently be on either a third generation aromatase inhibitor, tamoxifen or
fulvestrant and have a documented evidence of progressive disease after:

1. taking ET as adjuvant therapy for >2 years or

2. 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;

10. Suitable for continuing endocrine therapy according to the treating clinician. The
window of discontinuation must not exceed 4 weeks.

11. 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.

12. 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.

13. No more than one prior line of chemotherapy/targeted therapy for metastatic/locally
advanced breast cancer.

14. Patients with adequately controlled hepatitis C or hepatitis B surface antigen.

15. 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);

16. 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;

17. Female patients of childbearing potential must have a negative serum or urine
pregnancy test at day 1 of the study.

Exclusion Criteria:

1. Rapidly progressive visceral disease not suitable for further endocrine therapy;

2. Currently on chemotherapy or any other combination treatment for their MBC other than
AI, tamoxifen or fulvestrant;

3. Radiotherapy less than 2 weeks prior to study entry;

4. Major surgery (excluding placement of vascular access) within 4 weeks before the first
dose of study treatment;

5. 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;

6. 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;

7. 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;

8. An existing serious disease, illness, or condition that will prevent participation or
compliance with study procedures;

9. Patients with unresolved or unstable serious toxicity from prior administration of
another investigational drug and/or prior cancer treatment;

10. 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.

11. Concurrent treatment with another investigational agent or participated in another
investigational trial



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Breast Neoplasm
Intervention(s)
Drug: Tamoxifen
Drug: SFX-01
Drug: Fulvestrant
Drug: Aromatase Inhibitors
Primary Outcome(s)
Clinical benefit rate [Time Frame: 24 weeks]
Treatment-Emergent Adverse Events [Safety and Tolerability]) [Time Frame: 28 weeks]
Secondary Outcome(s)
Objective Response rate [Time Frame: 24 Weeks]
Progression Free Survival [Time Frame: 24 Weeks]
Time to Progression [Time Frame: 24 Weeks]
Clinical Benefit [Time Frame: 24 Weeks]
Overall Survival [Time Frame: 24 Weeks]
Time to next Treatment [Time Frame: 24 weeks]
Time To Response [Time Frame: 24 weeks]
Secondary ID(s)
EVG001BC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Premier Research Group plc
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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