Patients with histologically or cytologically confirmed ER-positive MBC at first evidence of metastatic disease.
Conditions
Interventions
Product Name: 16-a-[18F]fluoro-17-ß-fluoroestradiol
Product Code: 16-a-[18F]fluoro-17-ß-fluoroestradiol
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: 18-F Fluoroestr
Sponsors
Università del Piemonte Orientale
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically confirmed breast cancer - Metastatic disease, stage IV - No prior treatments for metastatic breast cancer - HER2 negative disease, as measured locally by IHC or FISH (standard clinical practice) - Endocrine-sensitive disease as evaluated locally, by ER expression at the time of diagnosis on the primary tumor. - Prior endocrine therapy is allowed only in the adjuvant setting - Prior adjuvant/neoadjuvant chemotherapy is allowed provided it is terminated at least 12 months before study entry. Adjuvant anthracyclines and adjuvant taxanes are allowed. - Patients progressed during or after adjuvant endocrine therapy are eligible - Radiation therapy, if given and regardless of site, must be completed at least 2 weeks prior to randomization. - Measurable or non measurable, but evaluable disease. - Visceral, and/or soft tissue and/or bone metastases - Eastern Cooperative Oncology Group (ECOG) performance status 3 months - No history of other malignancies - Signed written informed consent - Ability to comply with the study protocol - Age 18 years or older - Availability of an FFPE block from the primary tumor (breast lesion) for submission to central pathology review. - A biopsy of metastatic lesions is recommended, if technically feasible. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: - HER-2 positive disease - Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, during the two weeks before entry into the study - Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder). - Brain or leptomeningeal metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 36;Main Objective: Disease Control Rate, as defined by the proportion of patients who do not experience disease progression within 3 months of treatment. ;Secondary Objective: The primary objective of this study is to compare the activity of first line endocrine therapy versus first line chemotherapy in MBC in patients with ER-positive phenotypes and SUV 18F-FES < 2 at basal CT/PET scan. ;Primary end point(s): Disease Control Rate, as defined by the proportion of patients who do not experience disease progression within 3 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3. To evaluate Disease Control Rate, within 24 weeks of treatment. 4. To correlate ER expression in the primary tumor and overall FES-uptake in metastases. 5. To correlate ER expression in metastatic biopsies (when available) and in the primary tumor. 6. To evaluate estrogen-related gene expression by PCR on primary tumors and available metastatic biopsies. 7. To correlate the response rate (according to RECIST 1.1) of individual metastatic lesions with their 18F-FES uptake. 8. To develop and validate newer tests able to predict endocrine resistance in ER+ tumors, based on the assessment of factors such as PgR expression, oncogenerelated escape pathways and steroid receptor co-activators. 9. To combine biological and functional information to construct a prediction algorithm of endocrine responsiveness in ER+ MBC ;Timepoint(s) of evaluation of this end point: 36 | — |
Countries
France, Germany, Italy, Spain
Contacts
Public Contactalessandra.gennari@med.uniupo.it
e.o. ospedali galliera
Outcome results
None listed