Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT01275859
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Female patients
* Histologically confirmed invasive breast cancer
* Primary tumor greater than 2cm diameter, measured by sonography
* N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)
* ER positive (intermediate and strong positive)
* HER2 positive (IHC3+ or FISH positive in case of IHC 2+)
* No evidence of metastasis (M0)
* No prior hormonal, chemotherapy or radiotherapy is allowed
* No breast operation other than biopsy to make diagnosis is allowed
* Postmenopausal women with ECOG Performance Status of 0 or 1
* Postmenopausal, as defined by any of the following:
* At least 55 years of age
* Under 55 years of age and amenorrheic for at least 12 months OR follicle-stimulating hormone (FSH) values ≥ 30 IU/L and estradiol levels ≤ 20 IU/L
* Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months
* Adequate hematopoietic, renal, hepatic function:
Exclusion Criteria:
* Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
* Patients who underwent surgery for breast cancer
* Patients with bilateral invasive breast cancer
* Patients with inflammatory breast cancer (T4d)
* Patients without primary tumor (T0) Inability to perform \[18F\]FES PET imaging due to physical inability, claustrophobia, or other mental illness.
* ER poor disease as defined locally (e.g: Allred score 1-3, H-score\<100)
* Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
* Chronic daily treatment with aspirin (\>325mg/day) or clopidogrel (\>75mg/day)
* Chronic daily treatment with corticosteroids (dose of \>10mg /day ethylprednisolone equivalent)
* Clinically significant cardiovascular disease: CVA/stroke (\<6month prior to enroll), MI (\<6month prior to enroll), unstable angina, NYHA Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.
* Hormone replacement therapy within 4 weeks of starting treatment
* Known hypersensitivity to any of the study drugs including ditosylate monohydrate salt
* Pregnant or nursing mother (if applicable)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01275859
Study Brief:
Protocol Section:
NCT01275859