Clinical trial · Interventional
Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer
A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer
NCT00191243CI-TRIAL-00040581completedPhase 2ClinicalTrials.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)
Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine. Aim of the study is to assess the optimal dosage and safety in this setting.
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 |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Gemcitabine
- Drug: docetaxel
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: Gemcitabine
- Drug: docetaxel
Primary outcomes (1)
- measure
- Time to treatment failure (TTTF)
- timeFrame
- baseline to stopping treatment
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * histologically verified diagnosis of breast carcinoma, at first diagnosis * restricted previous adjuvant chemotherapy (completed \>6 months prior the study) * measurable and/or non-measurable disease * previous radiotherapy is allowed if:terminated at least 10 days prior the sudy therapy, at least one target lesion for evaluation of tumor response has not been irradiated * performance status 0-2 (WHO, Zubrod) * adequate bone marrow reserve defined * adequate liver / renal functions defined Exclusion Criteria: * any prior systematic chemotherapy for metastatic breast cancer * expected survival time less than 12 weeks * past or current history of malignant neoplasm other than breast carcinoma * except for cured non-melanoma skin cancer or curatively treated in situ carcinoma of the cervix uteri * known brain metastases/leptomeningeal involvement * active uncontrolled infection * symptomatic peripheral neuropathy \> grade 2 according to NCI * patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease * concomitant illness that is contraindication to the use of corticosteroids * other concomitant serious illness or medical condition, which may worsen due to the treatment
References
Publications (1)
- RESULTJoensuu H, Sailas L, Alanko T, Sunela K, Huuhtanen R, Utriainen M, Kokko R, Bono P, Wigren T, Pyrhonen S, Turpeenniemi-Hujanen T, Asola R, Leinonen M, Hahka-Kemppinen M, Kellokumpu-Lehtinen P. Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial. Ann Oncol. 2010 May;21(5):968-73. doi: 10.1093/annonc/mdp397. Epub 2009 Oct 9. PMID 19819914