capecitabine maintenance therapy following capecitabine combined with docetaxel in treatment of mbc

Conditions: Breast Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Breast Diseases; Skin Diseases

Summary: 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).


Eligibility criteria:
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.

Keywords: metastatic breast cancer antineoplastic agents therapeutic uses antimetabolites tubulin modulators maintenance chemotherapy metronomic chemotherapy capecitabine docetaxel