Phase 2
N=51
Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00209092 ↗Enrolled (actual)
51
Serious AEs
33.3%
Results posted
Jun 2012
Primary outcome: Primary: Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. — 2; 3; 15; 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Docetaxel (Drug); Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer. |
2; 3; 15; 23; 3; 1 | — |
| SECONDARY Long Term Follow up Data on Recurrence and Survival |
19; 21 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00209092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.