Clinical trial · Interventional
Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-weeks Regimen
NCT03147963CI-TRIAL-00027512unknownPhase 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)
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Docetaxel 2-Weeks regimen group
- description
- Docetaxel injection 50mg/m2,iv,d1,every 2 weeks
- interventionNames
- Drug: Docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel 3-Weeks regimen group
- description
- Docetaxel injection 75mg/m2,iv,d1,every 3 weeks
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
- From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * The age is Above 18 years of age, \<70 years old * The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative * Clinical stage was metastatic breast cancer or locally advanced breast cancer. * Must have at least one measurable lesion, according to RECISTv1.1. * Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~2 * Docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months. * The basic function of normal bone marrow * Functions of liver and kidney is normal * Expectation of life is more than 3 months * Agreed to take contraceptive measures during treatment Exclusion Criteria: * The patient had a history of allergy to taxanes or their components. * Recent progress of taxanes in 6 months. * In the elution period of other chemotherapy regimens. * Severe coagulopathy. * HER2 positive breast cancer * Previous toxicity was not recovered to 0-1 degrees * Central nervous system metastasis had not Controlled yet * Pregnancy or lactation * There are uncontrolled infection, myocardial infarction, thrombosis, etc. * There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease; * HIV infection * Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix; * Researchers believe that is not suitable for the study
References
Publications (1)
- BACKGROUNDNabholtz JM, Falkson C, Campos D, Szanto J, Martin M, Chan S, Pienkowski T, Zaluski J, Pinter T, Krzakowski M, Vorobiof D, Leonard R, Kennedy I, Azli N, Murawsky M, Riva A, Pouillart P; TAX 306 Study Group. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol. 2003 Mar 15;21(6):968-75. doi: 10.1200/JCO.2003.04.040. PMID 12637459