Clinical trial · Interventional
Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant, Dose-Dense Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
NCT00209092CI-TRIAL-00017288completedPhase 2Results postedClinicalTrials.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)
The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
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 |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Sequential Therapy
- description
- Docetaxel will be given at 100mg/m\^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
- interventionNames
- Drug: Docetaxel
- Drug: Capecitabine
- type
- ACTIVE_COMPARATOR
- label
- Concurrent Therapy
- description
- Docetaxel will be given at 50mg/m\^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
- interventionNames
- Drug: Docetaxel
- Drug: Capecitabine
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed breast carcinoma. * Early stage breast cancer (stage 1, 2, 3). * No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes. * 18 years of age or older. * Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Exclusion Criteria: * Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. * Major surgery within 28 days of study entry. * Evidence of central nervous system (CNS) metastases. * Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
References
Publications (2)
- RESULTZelnak AB, Styblo TM, Rizzo M, Gabram SG, Wood WC, Harichand-Herdt S, Kim S, Liu Y, O'Regan RM; Georgia Center for Oncology Research and Education. Final results from phase II trial of neoadjuvant docetaxel and capecitabine given sequentially or concurrently for HER2-negative breast cancers. Clin Breast Cancer. 2013 Jun;13(3):173-9. doi: 10.1016/j.clbc.2012.12.004. Epub 2013 Jan 16. PMID 23332349
- DERIVEDHoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2. PMID 34037241