Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer (Neo-ACET BC)

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status and phase: Terminated; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Anastrozole plus tegafur-uracil; Drug: Anastrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT01262274

TRIBC1009

Details and patient eligibility

About

The Aim of this study is to validate a treatment of anastrozole in combination with tegafur-uracil as pre-operative therapy for postmenopausal primary breast cancer. Although pre-operative hormone therapy is a novel therapeutic approach, only hormone therapy has limitation in terms of efficacy. Metronomic chemotherapy, which is the frequent administration of low-dose cytotoxic agents, is not only target tumor cells but also inhibiting angiogenesis. Because there was a report that efficacy of hormone therapy add to metronomic chemotherapy as pre-operative therapy, a randomized phase II trial of anastrozole (ANA) in combination with/without metronomic tegafur-uracil (UFT) as neo-adjuvant for postmenopausal breast cancer will be conducted.

Enrollment: 57 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically-confirmed diagnosis of invasive breast cancer
• Clinical stage T2, N0 or N1, M0 (TNM Classification)
• Patients must be postmenopausal
• Tumors are estrogen receptor (ER) positive and human epidermal growth factor receptor (HER2) negative
• ECOG Performance status (PS) 0 or 1
• Patients must be able to swallow tablets and capsules
• Candidates for mastectomy or breast-conserving surgery
• Adequate bone marrow, liver and renal function
• Written informed consent was obtained from all patients before randomization.

Exclusion criteria

• Inoperable, bilateral or inflammatory breast cancer
• multiple carcinoma
• Personal history of invasive carcinoma
• Patients receive systemic therapy of corticosteroid
• Patients receive estrogen preparation or raloxifene
• Patients with other concurrent severe and/or uncontrolled medical disease
• Patients whom doctors judged inadequate to the enrollment of this study by other reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

ANA

Active Comparator group

Treatment:

Drug: Anastrozole

ANA+UFT

Experimental group

Treatment:

Drug: Anastrozole plus tegafur-uracil