Phase 3
Completed N=241
Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC
Metastatic Breast Cancer (MBC)
Source: ClinicalTrials.gov NCT00236899 ↗
Enrolled (actual)
241
Serious AEs
15.6%
Results posted
Sep 2011
Primary outcomePrimary: Time to Progressive Disease (TTPD) by Treatment Schedule — 8.33; 7.51 months — p=0.345
Summary
Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progressive Disease (TTPD) by Treatment Schedule |
8.33; 7.51 | 0.345 |
| PRIMARY Time to Progressive Disease (TTPD) by Treatment Drug |
7.74; 7.80 | 0.150 |
| SECONDARY Overall Survival (OS) by Treatment Schedule |
21.11; 20.95 | 0.885 |
| SECONDARY Overall Survival (OS) by Treatment Drug |
19.11; 23.80 | 0.976 |
| SECONDARY Overall Response Rate (ORR) by Treatment Schedule |
50.43; 33.06; 6.84; 5.65; 43.59; 27.42 | 0.0028 sig |
| SECONDARY Overall Response Rate(ORR) by Treatment Drug |
43.2; 39.8; 5.08; 7.32; 38.14; 32.52 | 0.4567 |
| SECONDARY Number of Participants With Serious and Nonserious Adverse Events (AEs) |
9; 10; 7; 11; 57; 58 | — |
| SECONDARY Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at Beginning of 3-Week or 4-Week Cycle |
3; 1; 2; 4; 13; 13 | 0.142 |
| SECONDARY Quality of Life (QOL) Using the Rotterdam Symptom Scale Checklist (RSSC) at 30-Day Post-therapy Visit |
0; 0; 0; 0; 7; 7 | 0.293 |
Eligibility Criteria
Inclusion Criteria
- Histologic diagnosis of metastatic breast cancer (MBC).
- Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
- Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
- Patients with measurable disease.
- Previous hormonal therapy for adjuvant setting or metastatic disease.
Exclusion Criteria
- Previous chemotherapy for MBC
- Previous chemotherapy with gemcitabine in any setting of disease
- Patient candidable to treatment with trastuzumab.
Data sourced from ClinicalTrials.gov (NCT00236899). 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. Informational only — not medical advice.