Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

Trial Title: Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

NCT ID: NCT01917279

Condition: Breast Neoplasms
Neoplasms by Site
Neoplasm Metastasis
Breast Diseases
Skin Diseases

Conditions: Official terms:
Neoplasms
Neoplasm Metastasis
Breast Neoplasms
Neoplasms by Site
Skin Diseases
Breast Diseases
Docetaxel
Capecitabine

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

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Docetaxel plus Capecitabine
Description: Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration. For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase.
Arm group label: Intermittent Capecitabine
Arm group label: Metronomic Capecitabine

Intervention type: Drug
Intervention name: Intermittent Capecitabine
Description: Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle
Arm group label: Intermittent Capecitabine

Other name: Xeloda

Intervention type: Drug
Intervention name: Metronomic Capecitabine
Description: Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle
Arm group label: Metronomic Capecitabine

Other name: Xeloda

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:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Institute and Hospital, Chinese Academy Of Medical Sciences

Address:
City: Beijing
Zip: 100021
Country: China

Status: Recruiting

Contact:
Last name: Binghe Xu, MD, PhD

Phone: +86-10-87788826
Email: xubinghe@medmail.com.cn

Contact backup:
Last name: Fei Ma, MD

Phone: +86-13910217780
Email: mafei2011@139.com

Investigator:
Last name: Binghe Xu, MD, PhD
Email: Principal Investigator

Investigator:
Last name: Fei Ma, MD
Email: Sub-Investigator

Start date: October 2013

Completion date: July 2021

Lead sponsor:
Agency: Binghe Xu
Agency class: Other

Collaborator:
Agency: Hoffmann-La Roche
Agency class: Industry

Source: ChineseAMS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01917279