CYP2D6 Polymorphism Clinical Trial
— STEPOfficial title:
A Randomized Controlled Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations (STEP)
Verified date | October 2018 |
Source | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, randomized, open-label, parallel, active-controlled superiority clinical study conducted in early premenopausal estrogen-receptor positive breast cancer patients with CYP2D6*10 mutations. The efficacy and safety of Exemestane Tablets combined with ovarian function suppression/ablation and Tamoxifen Tablets combined with ovarian function suppression/ablation in the treatment of early premenopausal estrogen-receptor positive breast cancer patients with CYP2D6*10 mutations are compared.
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | October 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | CancerIHCAMS | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Pfizer |
China,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Breast cancer free survival | Breast cancer free survival is defined as the time from randomization to the first observation of breast cancer local/distant recurrence or occurrence of contralateral breast cancer | It will be conducted once every 3 months in the first 2 years during the treatment period, every 6 months in 3 and 4 years, every 12 months in 5 years | |
Other | Distant relapse free survival | Distant relapse free survival is defined as the time from randomization to the first observation of breast cancer distant recurrence | It will be conducted once every 3 months in the first 2 years during the treatment period, every 6 months in 3 and 4 years, every 12 months in 5 years | |
Other | The occurrence rate of the contralateral breast cancer | The occurrence rate of the contralateral breast cancer is defined as contralateral breast cancer occurrence rate in patients from two groups after randomization | It will be conducted once every 3 months in the first 2 years during the treatment period, every 6 months in 3 and 4 years, every 12 months in 5 years | |
Other | the psychosocial factors in patients with breast cancer | To investigate the psychosocial changes in patients with breast cancer during endocrine therapy | It will be conducted once every 3 months in the first 2 years during the treatment period, every 6 months in 3 and 4 years, every 12 months in 5 years | |
Primary | Disease free survival (DFS) | It is defined as the time from randomization to the first breast cancer local/distant recurrence, the new breast cancer of the contralateral breast, second primary cancer and the death caused by any reason | the first breast cancer local/distant recurrence, the new breast cancer of the contralateral breast, second primary cancer and the death caused by any reason in 5 years | |
Secondary | Recurrence rate (local or distant) | Recurrence rate (local or distant) is defined as breast cancer local or distant recurrence rate in patients from two groups | It will be conducted once every 3 months in the first 2 years during the treatment period, every 6 months in 3 and 4 years, every 12 months in 5 years | |
Secondary | Overall survival (OS) | OS is defined as the time from randomization to death due to any reasons | It will be conducted once every 3 months in the first 2 years during the treatment period, every 6 months in 3 and 4 years, every 12 months in 5 years | |
Secondary | Incidence of Treatment-Emergent Adverse Events | Results of AE/serious adverse event (SAE), clinical lab tests, 12 lead ECG, vital signs and physical examination will be evaluated throughout the study to monitor the safety of subjects | It will be conducted once every 3 months in the first 2 years during the treatment period, every 6 months in 3 and 4 years, every 12 months in 5 years |
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