A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations （STEP）

• Status: Enrolling by invitation
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborator: Pfizer
• Treatments: Exemestane; Tamoxifen

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.