Clinical trial · Interventional
Three Doses of TAS-108 to Treat Recurrent or Recurrent Inoperable Breast Cancer
A Phase II, Randomized, Double-Blinded Efficacy and Safety Study of Three Doses of TAS-108 Administered Orally in Postmenopausal Patients With Locally Advanced or Locally Recurrent Inoperable or Progressive Metastatic Breast Cancer Following Standard First-Line Endocrine Therapy
NCT00166543CI-TRIAL-00018863completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to find out how safe TAS-108 is and how well TAS-108 works on recurrent or recurrent inoperable breast cancer.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS-108 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- TAS-108 40 mg
- interventionNames
- Drug: TAS-108
- type
- EXPERIMENTAL
- label
- TAS-108 80 mg
- interventionNames
- Drug: TAS-108
- type
- EXPERIMENTAL
- label
- TAS-108 120 mg
- interventionNames
- Drug: TAS-108
Primary outcomes (3)
- measure
- To evaluate the safety of TAS-108 administered on this schedule
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal females * Histologically or cytologically confirmed diagnosis of breast carcinoma * Locally advanced or locally recurrent inoperable or metastatic breast carcinoma with documented disease progression * Has laboratory documentation of positive estrogen receptor (ER) and/or progesterone receptor (PgR) status, and has responded to the standard first or second line hormonal anti-tumor therapy given * Has received and whose disease progressed after one or two prior systemic hormonal anti-tumor therapies * Performance status of greater than or equal to 2 on the Zubrod scale * Predicted life expectancy of greater than or equal to 12 weeks * Must give written informed consent * Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Absolute granulocyte count of greater than 1,500/meqL, platelet count greater than 75,000/meqL, and a hemoglobin of greater than 10 g/dL * Adequate liver and renal function as defined by a bilirubin of less than 1.5 times the upper limit of normal and a creatinine of less than 1.5 times the upper limit of normal * Transaminases must be less than 2.5 times the upper limit of normal except for patients with liver metastases who may have transaminases less than 5 times the upper limit of normal. * The patient has recovered from all previous anti-cancer treatment related to toxicities to at least Grade 1. * All previous investigational drugs must be stopped at least four weeks before commencement of treatment with TAS-108.
References
Publications (0)
Data not yet available
No reference posted for this study.