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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT03137368
Eligibility Criteria:
Inclusion Criteria:
* Providing informed consent forms voluntarily before screening evaluation;
* For Chinese premenopausal women, her estradiol level must be within the premenopausal level, or the patient meet the following 4 criteria in the prior 6 months: No chemotherapy, Regular menstruation, No use of hormonal, contraceptives, No use of hormone for treatment or for temporary amenorrhea caused by chemotherapy, the estradiol level tested within 8 months after the last dose of chemotherapeutics is within the premenopausal level;
* Patients with invasive breast cancer which has been confirmed by histological examination;
* Complete removal of tumor by surgery without local residual;
* Neoadjuvant chemotherapy before surgery is permitted if the surgery for primary breast cancer is performed within 12 weeks without any further adjuvant chemotherapy, or adjuvant chemotherapy is completed within 8 months;
* Estrogen receptor (ER) and/or progesterone receptor (PR) positive: If the patient has more than one breast tumor lesions, each tumor lesion should be ER and/or PR positive.
* Her-2 negative;
* Genotyping test performed by the central laboratory designated by sponsor with the results confirmed as CYP2D6\*10T/T gene mutation.
* Women of childbearing age with negative serum pregnancy test result, and agreeing to adopt highly efficient non-hormonal contraception measure throughout the study;
* Subject without major organ dysfunction, and with normal heart, liver, kidney, lung and other major organ function.
Exclusion Criteria:
* Inflammatory breast cancer;
* Breast cancer patients with supraclavicular lymph nodes metastasis;
* Patients with enlarged internal mammary lymph nodes (except for patients with negative pathologic findings);
* Ovariectomy which is not specified in the study;
* Patients with ovary protection during the chemotherapy;
* Concomitant use of other aromatase inhibitors (not Exemestane);
* Received major surgery which was unrelated to breast cancer within four weeks before randomization, or the patients had not yet fully recovered from such surgery;
* Pregnant or lactating women;
* Known active hepatitis B or hepatitis C or HIV;
* Having difficulty in swallowing oral preparations and gastrointestinal dysfunction;
* Recently had severe and uncontrolled systemic diseases (e.g.: cardiovascular disease, lung disease, or metabolic disease, venous thrombosis with clinical significance);
* Currently or previously suffering from other malignant tumors (except for skin basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of cervix which had been fully treated), unless a radical treatment had been done with the evidence of no-recurrence or metastasis in nearly five years;
* Allergic to any study drug or any ingredients of drug;
* Patient with poor compliance or other conditions which makes the patient unsuitable to participate in this study judged by the investigator.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT03137368
Study Brief:
Protocol Section:
NCT03137368