Clinical trial · Interventional
Capecitabine in Women With Operable Breast Cancer
A Phase II Study of Preoperative Capecitabine in Women With Operable Breast Cancer
NCT00148720CI-TRIAL-00019755terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
The purpose of this study is to find out what effects (good and bad) taking capecitabine for 12 weeks before surgery will have on women with breast cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Primary Invasive Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Stage I Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the response rate following four cycles of preoperative capecitabine in women with operable breast cancer.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of primary invasive breast cancer * Stage I-III operable breast cancer. * Primary tumor must be greater than or equal to 2cm by radiographic imaging or palpitation * Women greater than 18 years of age * ECOG performance status 0-1 * WBC \> 4000/mm3 * Platelet count \> 100,000/mm3 * SGOT \< 2x ULN * Calculated creatinine clearance \> 50ml/min Exclusion Criteria: * Evidence of metastatic (stage IV) cancer on physical exam or any diagnostic study. * Pregnant or breast-feeding women * Inflammatory breast cancer * HER2 positive disease * History of hypersensitivity to a 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency * Uncontrolled intercurrent illness * Prior history of breast cancer are ineligible except: diagnosed at least 2 years ago; present cancer is not in previously irradiated breast; no prior chemotherapy in the past 5 years; no prior high-dose chemotherapy with stem cell or bone marrow transplant. * Excisional biopsy performed prior to enrollment * Uncontrolled coagulopathy * Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
References
Publications (1)
- RESULTTolaney SM, Jeong J, Guo H, Brock J, Morganstern D, Come SE, Golshan M, Bellon J, Winer EP, Krop IE. A phase II study of preoperative capecitabine in women with operable hormone receptor positive breast cancer. Cancer Med. 2014 Apr;3(2):293-9. doi: 10.1002/cam4.164. Epub 2014 Jan 27. PMID 24464780