Clinical trial · Interventional
Docetaxel With or Without Metronomic Cyclophosphamide as First Line Chemotherapy in Metastatic Breast Cancer
NCT01526499CI-TRIAL-00006213unknownPhase 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)
The purpose of this study is to evaluate the role of metronomic cyclophosphamide in addition to docetaxel in first line therapy in metastatic breast cancer.
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 and Cyclophosphamide (TC) | Drug | — | UNRESOLVED |
| Docetaxel (T) | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TC
- description
- Docetaxel plus Cyclophosphamide
- interventionNames
- Drug: Docetaxel and Cyclophosphamide (TC)
- type
- ACTIVE_COMPARATOR
- label
- T
- description
- Docetaxel
- interventionNames
- Drug: Docetaxel (T)
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 6 weeks
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females with age between 18 and 70 years old 2. ECOG performance between 0-1 3. Life expectancy more than 3 months 4. Histological proven unresectable recurrent or advanced breast cancer 5. No previous chemotherapy for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year). 6. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1) 7. No anticancer therapy within 4 weeks 8. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney 9. Provision of written informed consent prior to any study specific procedures Exclusion Criteria: 1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound) 2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study 3. Treatment with an investigational product within 4 weeks before the first treatment 4. Symptomatic central nervous system metastases 5. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 6. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 7. Uncontrolled serious infection 8. Patients with bad compliance
References
Publications (0)
Data not yet available
No reference posted for this study.