Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC
Information source: Chinese Academy of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Neoplasms; Neoplasms by Site; Neoplasm Metastasis; Breast Diseases; Skin Diseases
Intervention: Docetaxel plus Capecitabine (Drug); Capecitabine (Drug); Capecitabine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Binghe Xu Official(s) and/or principal investigator(s): Binghe Xu, MD, PhD, Principal Investigator, Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall contact: Binghe Xu, MD, PhD, Phone: +86-10-87788826, Email: xubinghe@medmail.com.cn
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).
Clinical Details
Official 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression Free Survival (PFS)
Secondary outcome: Adverse events (AEs)Overall survival (OS): Overall Response rates (ORR) Clinical Benefit rate (CBR) Time to Progression (TTP) QoL
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
Binghe Xu, MD, PhD, Phone: +86-10-87788826, Email: xubinghe@medmail.com.cn
Cancer Institute and Hospital, Chinese Academy Of Medical Sciences, Beijing 100021, China; Recruiting Binghe Xu, MD, PhD, Phone: +86-10-87788826, Email: xubinghe@medmail.com.cn Fei Ma, MD, Phone: +86-13910217780, Email: mafei2011@139.com Binghe Xu, MD, PhD, Principal Investigator Fei Ma, MD, Sub-Investigator
Additional Information
Starting date: October 2013
Last updated: November 21, 2013
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