Clinical trial · Interventional
Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy
A Randomized, Double-blind, Placebo-controlled Study of Capecitabine in the Treatment of Early-stage Breast Cancer With Low-hormone Receptor Expression and Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
- 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)
Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer and is particularly effective in patients with triple-negative breast cancer (TNBC). CREATE-X clinical studies have demonstrated that Capecitabine can further improve prognosis and demonstrate good tolerance in patients who have not achieved pathologic complete response (pCR) after neoadjuvant chemotherapy. Previous studies have confirmed that the pathological features of the low- hormone receptor (HR)positive population in breast cancer are similar to those in the TNBC population, with a poor prognosis and are not sensitive to adjuvant endocrine therapy. We hypothesize that the use of Capecitabine in breast cancer patients with residual invasive carcinoma after neoadjuvant chemotherapy may improve prognosis.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Placebos | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Capecitabine
- description
- The experimental group received oral capecitabine for eight cycles.
- interventionNames
- Drug: Capecitabine
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- The placebo group received oral placebo for eight cycles.
- interventionNames
- Drug: Placebos
Primary outcomes (2)
- measure
- Event Free Survival(DFS)
- timeFrame
- Time of Surgery up to 5 years.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of informed consent 2. Women and men at least 18 years of age or older. 3. Pathological confirmation of breast cancer 4. Tumor stage(TNM): T1-4N0-3M0 5. No evidence of distant metastasis 6. Adequate bone marrow, hepatic, and renal function 7. Measurable disease as per RECIST criteria 8. Karnofsky≥70 9. Laboratory criteria: PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST\<2\*ULN Exclusion Criteria: 1. Presence of metastatic disease. 2. Inflammatory breast cancer. 3. Bilateral breast cancer. 4. Postoperative treatment with other adjuvant chemotherapy drugs. 5. Other malignant tumors (concurrent or previous). 6. Pregnant woman. 7. Hypersensitive to any drug in Capecitabine or any ingredient of Capecitabine. 8. Any severe systemic disease contraindicating chemotherapy.
References
Publications (0)
Data not yet available