Evaluation of the Usefulness of Pre-operative Exemestane (EXE) Therapy for Treatment of Hormone-Sensitive Breast Cancer in Postmenopausal Patients, and EXE + Low-Dose CPA Combination Therapy for Nonresponders to EXE Therapy.(JBCRG-11CPA)
- Conditions
- ER positive, HER2 negative, Stage II or IIIA [T2-3,N0-2,M0], Primary Postmenopausal Invasive Breast Cancer Patients
- Registration Number
- JPRN-UMIN000004751
- Lead Sponsor
- Japan Breast Cancer Research Group (JBCRG)
- Brief Summary
Results Clinical response rates (CR and PR) at weeks 24 and 36 were 85% and 71%, respectively, in group A; and 54% and 71%, respectively, in group B. At week 36, no significant difference was found in median Ki67 index between the groups (3.5% and 4.0%). Conclusions Our findings provide support for the potential benefit of a tailored approach to neoadjuvant treatment in postmenopausal patients with ER-positive breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 59
Not provided
(1) Prior treatment for the breast cancer by chemotherapy or hormone therapy (2) Medication that may affect the sex hormone status (hormone replacement therapy, raloxifene, etc.) (eligible if the last dose was at least two months before) (3) Past history of breast cancer or presence of active multiple cancers (eligible if DCIS is located on the other side) (4) Bilateral breast cancer (if tumors on both sides meet the eligibility criteria, the case is not excluded.) (5) Cases for whom non-hormonal therapies such as surgical therapy, chemotherapy, or antibody therapy are recommended as the first treatment of choice (6) Past history of hypersensitivity to any drug or contrast agent used in this study (7) Cases in which another study drug is given for a disease other than breast cancer (8) Cases in which study participation is considered difficult due to the coexistence of psychosis or psychiatric symptoms (9) Cases considered ineligible by the attending physician for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical response at Week 24 and Week 36
- Secondary Outcome Measures
Name Time Method (1) Histological response rate. (2) Survival and relapse-free survival: To examine the tumor regression effect between Week 8 and 12, and at Week 24 and 36 and the correlation with Ki67 index values before and after the treatment. (3) Clinical benefit: Breast-conserving surgery rate, axillary lymph node metastasis positive rate (reduction rate from the baseline status), local relapse rate. (4) To explore clinicopathologic and molecular biological markers related to the tumor regression effect and long-term prognostic prediction. (5) Development of adverse events: To verify the safety.