Clinical trial · Interventional
Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC
A Randomized Phase III Study of Metronomic vs. Intermittent Capecitabine Maintenance Therapy Following First-line Capecitabine and Docetaxel Therapy in HER2-negative Metastatic Breast Cancer
NCT01917279CI-TRIAL-00046122CAMELLIAunknownPhase 3ClinicalTrials.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)
It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).
Conditions
Conditions (5)
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 Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Neoplasms by Site | Neoplasm by Site | ONTOLOGY_EXACT | 0.98 |
| Skin Diseases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel plus Capecitabine | Drug | — | UNRESOLVED |
| Intermittent Capecitabine | Drug | — | UNRESOLVED |
| Metronomic Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intermittent Capecitabine
- description
- Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.
- interventionNames
- Drug: Docetaxel plus Capecitabine
- Drug: Intermittent Capecitabine
- type
- EXPERIMENTAL
- label
- Metronomic Capecitabine
- description
- Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle
- interventionNames
- Drug: Docetaxel plus Capecitabine
- Drug: Metronomic Capecitabine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent obtained prior to initiation of any study-specific procedures or treatment as confirmation of the patient's awareness and willingness to comply with the study requirements. * Female patients aged ≥ 18 years. * Histologically confirmed and documented HER2-negative metastatic breast cancer. * Previously untreated first-line chemotherapy. * Patients with at least one measurable lesion according to RECIST criteria at study entry. * Documented ER/PgR status. * Prior hormone therapy for metastatic disease is allowed but must stop before study entry. * KPS\>70. * Life expectancy of ≥12 weeks Exclusion Criteria: * Previous chemotherapy for metastatic breast cancer. * Prior adjuvant/neoadjuvant chemotherapy within 6 months prior to first study treatment administration. * Prior (radical)radiotherapy for the treatment of metastatic disease or major surgical procedure within 28 days prior to the first study treatment, * Inadequate bone marrow function: absolute neutrophil count (ANC): \<1.5 x 109/L, platelet count\<75 x 109/L or hemoglobin \<100g/L. * Inadequate liver or renal function, defined as: 1. Serum (total) bilirubin \>2 x the upper limit of normal (ULN) for the institution 2. AST/SGOT or ALT/SGPT \>2.5 x ULN (\>5 x ULN in patients with liver metastases) 3. ALP \>2.5 x ULN at baseline (\>5 x ULN in patients with liver metastases). 4. Serum creatinine\>140umol/L. * Pregnant or lactating females. * Her-2 positive (ICH +++ or FISH positive). * Symptomatic cerebral parenchyma and/or leptomeningeal metastases. * Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer. * Pre-existing peripheral neuropathy ≥grade 1 according NCI CTCAE 4.0. * Mental disease or other conditions affecting on the compliance of patients. * Other serious disease or medical condition: 1. History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent. 2. Congestive heart failure, or unstable angina, myocardial infarction within ≤6 months prior to the first study treatment, uncontrolled hypertension and high risk, uncontrolled arrhythmias. 3. Uncontrolled acute infection * Inability to take or absorption oral medications. * Concurrent or within 30 days using drugs of other clinical trials. * Previous treatments containing Capecitabine (whether adjuvant or palliative treatment). * Previous treatments containing docetaxel within 12 months. * Known hypersensitivity to any of the study treatments or excipients. * Any other conditions the research consider not appropriate to take part in the trial.
References
Publications (2)
- DERIVEDYi Z, Feng K, Lv D, Guan Y, Shao Y, Ma F, Xu B. Genomic landscape of circulating tumor DNA in HER2-low metastatic breast cancer. Signal Transduct Target Ther. 2024 Dec 9;9(1):345. doi: 10.1038/s41392-024-02047-0. PMID 39648226
- DERIVEDGuan X, Ma F, Li C, Wu S, Hu S, Huang J, Sun X, Wang J, Luo Y, Cai R, Fan Y, Li Q, Chen S, Zhang P, Li Q, Xu B. The prognostic and therapeutic implications of circulating tumor cell phenotype detection based on epithelial-mesenchymal transition markers in the first-line chemotherapy of HER2-negative metastatic breast cancer. Cancer Commun (Lond). 2019 Jan 3;39(1):1. doi: 10.1186/s40880-018-0346-4. PMID 30606259