Clinical trial NCT01262274: Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Official title: Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Department of breast and endocrine surgery graduate school of Medicine Osaka University
First posted: 2010-12-17
Enrollment: 57
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Response Rate (confirmed by calipers CT or MRI)
timeFrame: six months
Secondary outcomes:
measure: Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor
timeFrame: seven months
Other outcomes:
Locations:
city: Osaka city
country: Japan
facility: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
state: Osaka prefecture
Study officials:
affiliation: Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine
name: Shinzaburo Noguchi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: