SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer
- Conditions
- 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 FulvestrantTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004851-28-FR
- Lead Sponsor
- Evgen Pharma PLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
The principal inclusion criteria are:
1.Male or female patients 18 years or older (the patient must be within the legal age limit to give informed consent in the jurisdiction the study is taking place in);
2.Patients with histologically confirmed estrogen receptor positive (ER+) breast cancer. Estrogen receptor is considered positive if a percentage score of =10% of tumour cells stain positive for ER.;
3.Histological confirmation of Human Epidermal Growth Factor Receptor 2 (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 1 site of measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) =10 mm with spiral computed tomography (CT) scan or magnetic resonance imaging (MRI) scan (malignant lymph nodes should be =15 mm 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 nonmeasurable);
6.Patients must have an anticipated life expectancy of at least 12 weeks;
7.Adequate bone marrow, renal and hepatic function defined as follows:
oHaemoglobin > 9 g/dL;
oAbsolute neutrophil count > 1.0 x 109/L;
oPlatelets > 100 x 109/L;
oTotal bilirubin within normal limits, except those with Gilbert’s syndrome for whom this must be <2.5 x ULN;
oAST(SGOT) or ALT(SGPT) < 2.5 x ULN;
oCalculated creatinine clearance > 30 ml/min;
8.Eastern Cooperative Oncology Group (ECOG) performance status < 2;
9.Must currently be on either a third generation Al, tamoxifen or fulvestrant and have a documented evidence of progressive disease after the following:
(a) taking endocrine therapy (ET) as adjuvant therapy for >2 years or
(b) achieving a best response of stable disease (for at least 6 months) or an objective response of complete response (CR) or partial response (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 suppressio
the principal exclusion criteria are:
1.Rapidly progressive visceral disease not suitable for further endocrine therapy;
2.Currently on chemotherapy for their metastatic breast cancer (MBC) even if this is in combination with 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 > 6 As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active infection with hepatitis B, hepatitis C and human immunodeficiency (HIV) viruses. Screening for chronic conditions is not required.;
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 unless adequate washout period per the investigational drug PK has been achieved (usually this is 5 half-lives of a product);
12.Females who are pregnant, wishing to become pregnant or breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method