EARLY PREDICTION OF EFFICACY OF ENDOCRINE THERAPY IN BREAST CANCER:PILOT STUDY AND VALIDATION WITH 18F FLUOROESTRADIOL (FES) PET/CT
- Conditions
- Patients with histologically or cytologically confirmed ER-positive Metastatic Breast Cancer at first evidence of metastatic disease.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000287-29-DE
- Lead Sponsor
- niversità del Piemonte Orientale
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 400
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 < 2
- Life expectancy > 3 months
- No history of other malignancies
4
- 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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220
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
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