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JBCRG-11CPA
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.
- Status
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Study Closed
- Objectives
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Exemestane will be administered to postmenopausal women with primary, resectable, hormone receptor-positive, Stage II or IIIA [T2-3, N0-2, -M0] breast cancer with a Ki67 index of under 30%. Exemestane will be continued in those whose tumor shows under 5% low proliferation with a Ki67 index and those who respond to it,*whereas combination therapy of exemestane + low dose CPA (cyclophosphamide) will be given to those who do not respond to exemestane. The study is aimed to examine the clinical response rate of the primary cancer and evaluable axillary lymph node metastasis to each therapy. At the same time, the histological effects, safety, clinical efficacy and relevance to the Ki67 index as well as the breast-conserving surgery rate, relapse-free survival and overall survival will be assessed. In addition, the antitumor effects as well as biological properties of the cancer tissue and the underlying mechanisms of resistance to Exemestane will be investigated using molecular biological and biochemical techniques.
- Subjects
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- Endpoints
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First: Clinical response at Week 24 and Week 36 Second: (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.
- Trial Period
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2010.Oct～2026.Mar（Entry period：5.5years, Follow up period ：10years from last entry）
- Lead Principal Investigator
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Niigata Cancer Center Hospital (Surgery) Nobuaki Sato
- Target Sample Size
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55
- Regimen
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exemestane + low dose CPA (cyclophosphamide)
- Source of Funding
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Japan Breast Cancer Research Group
- Conference Presentation
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Tailored neoadjuvant endocrine and chemo-endocrine therapy for postmenopausal patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative primary breast cancer
- Articles and Publications
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Neoadjuvant endocrine therapy with exemestane followed by response-guided combination therapy with low-dose cyclophosphamide in postmenopausal patients with estrogen receptor-positive breast cancer: a multicenter, open-label, phase II study Short title: Tailored neoadjuvant therapy for breast cancer
- UMIN-ID
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UMIN000004751
- jRCT
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- Memo
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- COI Disclosure
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