Breast Neoplasms Clinical Trial
— CAMELLIAOfficial title:
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
NCT number | NCT01917279 |
Other study ID # | ML28898 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | July 2021 |
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).
Status | Recruiting |
Enrollment | 280 |
Est. completion date | July 2021 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Cancer Institute and Hospital, Chinese Academy Of Medical Sciences | Beijing |
Lead Sponsor | Collaborator |
---|---|
Binghe Xu | Hoffmann-La Roche |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival (PFS) | Time from randomization to progression or death (whichever occurred first). | up to 36 months | |
Secondary | Adverse events (AEs) | Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0), premature withdrawals and vital signs. Hand-foot syndrome and diarrhea will be specially interested. Adverse events of special interest: hand-foot syndrome and diarrhea. The estimated HFS rate will be about 60% from intermittent Capecitabine vs about 10% from metronomic Capecitabine, diarrhea rate will be about 50% from intermittent Capecitabine vs about 10% from metronomic Capecitabine. |
up to 36 months | |
Secondary | Overall survival (OS): | Time from randomization to death | up to 52 months | |
Secondary | Overall Response rates (ORR) | Defined as CR+PR, assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase. | up to 36 months | |
Secondary | Clinical Benefit rate (CBR) | Defined as CR+PR+SD, assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase | up to 36 months | |
Secondary | Time to Progression (TTP) | Time from randomization to disease progression | up to 36 months | |
Secondary | QoL | Using the EORTC quality of life questionnaire QLQ-C30 | up to 36 months |
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