Clinical trial · Interventional
Randomized Phase II Trial of Anastrozole Plus Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Breast Cancer
Randomized Phase II Trial of Anastrozole in Combination With/Without Metronomic Tegafur-uracil as Neo-adjuvant Therapy in Postmenopausal Primary Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to an adverse event revelation.
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Anastrozole plus tegafur-uracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ANA
- interventionNames
- Drug: Anastrozole
- type
- EXPERIMENTAL
- label
- ANA+UFT
- interventionNames
- Drug: Anastrozole plus tegafur-uracil
Primary outcomes (1)
- measure
- Response Rate (confirmed by calipers CT or MRI)
- timeFrame
- six months
Secondary outcomes (1)
- measure
- Reduction Rate, Pathological response, Breast-conserving surgery rate, Adverse event rate, Predictive factor
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available