Clinical trial · Interventional
Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC
A Randomized Phase III Trial of Gemcitabine and Docetaxel Versus Gemcitabine and Paclitaxel in Patients With Metastatic Breast Cancer: A Comparison of Different Schedules
NCT00236899CI-TRIAL-00005553completedPhase 3Results 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)
Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).
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 |
|---|---|---|---|
| Metastatic Breast Cancer (MBC) | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A: Docetaxel and Gemcitabine (Tri-weekly)
- description
- Docetaxel and Gemcitabine (Tri-weekly)
- interventionNames
- Drug: Gemcitabine
- Drug: Docetaxel
- type
- EXPERIMENTAL
- label
- B: Paclitaxel and Gemcitabine (Tri-weekly)
- description
- Paclitaxel and Gemcitabine (Tri-weekly)
- interventionNames
- Drug: Gemcitabine
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- C: Docetaxel and Gemcitabine (Weekly)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDel Mastro L, Fabi A, Mansutti M, De Laurentiis M, Durando A, Merlo DF, Bruzzi P, La Torre I, Ceccarelli M, Kazeem G, Marchi P, Boy D, Venturini M, De Placido S, Cognetti F. Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments. BMC Cancer. 2013 Mar 28;13:164. doi: 10.1186/1471-2407-13-164. PMID 23537313