Clinical trial · Interventional
A Study to Evaluate Exemestane Tablets Combined With Ovarian Function Suppression/Ablation in Treatment of Premenopausal Breast Cancer Patients With CYP2D6*10 Mutations (STEP)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CYP2D6 Polymorphism | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYP2D6*10 gene test | Genetic | — | UNRESOLVED |
| Exemestane Tablets | Drug | Exemestane | ALIAS |
| ovarian function suppression/ablation | Other | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- Exemestane Tablets combined with ovarian function suppression/ablation
- interventionNames
- Drug: Exemestane Tablets
- Other: ovarian function suppression/ablation
- Genetic: CYP2D6*10 gene test
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Tamoxifen Tablets combined with ovarian function suppression/ablation
- interventionNames
- Other: ovarian function suppression/ablation
- Genetic: CYP2D6*10 gene test
- Drug: Tamoxifen
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (20)
- BACKGROUNDSchroth W, Goetz MP, Hamann U, Fasching PA, Schmidt M, Winter S, Fritz P, Simon W, Suman VJ, Ames MM, Safgren SL, Kuffel MJ, Ulmer HU, Bolander J, Strick R, Beckmann MW, Koelbl H, Weinshilboum RM, Ingle JN, Eichelbaum M, Schwab M, Brauch H. Association between CYP2D6 polymorphisms and outcomes among women with early stage breast cancer treated with tamoxifen. JAMA. 2009 Oct 7;302(13):1429-36. doi: 10.1001/jama.2009.1420. PMID 19809024
- RESULTSiegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5. PMID 25559415
- RESULTWilliams C, Brunskill S, Altman D, Briggs A, Campbell H, Clarke M, Glanville J, Gray A, Harris A, Johnston K, Lodge M. Cost-effectiveness of using prognostic information to select women with breast cancer for adjuvant systemic therapy. Health Technol Assess. 2006 Sep;10(34):iii-iv, ix-xi, 1-204. doi: 10.3310/hta10340. PMID 16959170
- RESULTGansler T, Ganz PA, Grant M, Greene FL, Johnstone P, Mahoney M, Newman LA, Oh WK, Thomas CR Jr, Thun MJ, Vickers AJ, Wender RC, Brawley OW. Sixty years of CA: a cancer journal for clinicians. CA Cancer J Clin. 2010 Nov-Dec;60(6):345-50. doi: 10.3322/caac.20088. PMID 21075954
- RESULTBuzdar A. The place of chemotherapy in the treatment of early breast cancer. Br J Cancer. 1998 Sep;78 Suppl 4(Suppl 4):16-20. doi: 10.1038/bjc.1998.757. PMID 9741784
- RESULTDezentje VO, Guchelaar HJ, Nortier JW, van de Velde CJ, Gelderblom H. Clinical implications of CYP2D6 genotyping in tamoxifen treatment for breast cancer. Clin Cancer Res. 2009 Jan 1;15(1):15-21. doi: 10.1158/1078-0432.CCR-08-2006. PMID 19118028
- RESULTBlackburn HL, Ellsworth DL, Shriver CD, Ellsworth RE. Role of cytochrome P450 genes in breast cancer etiology and treatment: effects on estrogen biosynthesis, metabolism, and response to endocrine therapy. Cancer Causes Control. 2015 Mar;26(3):319-32. doi: 10.1007/s10552-014-0519-7. Epub 2015 Jan 3.