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Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC
Conditions
Breast Neoplasms - Neoplasms by Site - Neoplasm Metastasis - Breast Diseases - Skin Diseases
Conditions: official terms
Breast Diseases - Breast Neoplasms - Neoplasm Metastasis - Neoplasms - Neoplasms by Site - Skin Diseases
Conditions: Keywords
Metastatic Breast Cancer, Antineoplastic Agents, Therapeutic Uses, Antimetabolites, Tubulin Modulators, Maintenance chemotherapy, Metronomic chemotherapy, Capecitabine, Docetaxel
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Docetaxel plus Capecitabine
Type: Drug
Name: Capecitabine
Type: Drug
Name: Capecitabine
Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
- 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.
Location
Cancer Institute and Hospital, Chinese Academy Of Medical Sciences
Beijing, China
Status: Recruiting
Contact: Binghe Xu, MD, PhD - +86-10-87788826 - xubinghe@medmail.com.cn
Start Date
October 2013
Completion Date
September 2018
Sponsors
Binghe Xu
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page