Status:
UNKNOWN
Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC
Lead Sponsor:
Binghe Xu
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Breast Neoplasms
Neoplasms by Site
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 D...
Eligibility Criteria
Inclusion
- 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
- 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:
- Serum (total) bilirubin \>2 x the upper limit of normal (ULN) for the institution
- AST/SGOT or ALT/SGPT \>2.5 x ULN (\>5 x ULN in patients with liver metastases)
- ALP \>2.5 x ULN at baseline (\>5 x ULN in patients with liver metastases).
- 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:
- History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent.
- Congestive heart failure, or unstable angina, myocardial infarction within ≤6 months prior to the first study treatment, uncontrolled hypertension and high risk, uncontrolled arrhythmias.
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT01917279
Start Date
October 1 2013
End Date
July 1 2021
Last Update
July 23 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Institute and Hospital, Chinese Academy Of Medical Sciences
Beijing, China, 100021