Clinical Trials /

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

NCT01917279

Description:

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).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: ML28898
  • NCT ID: NCT01917279

Conditions

  • Breast Neoplasms
  • Neoplasms by Site
  • Neoplasm Metastasis
  • Breast Diseases
  • Skin Diseases

Interventions

DrugSynonymsArms
Docetaxel plus CapecitabineIntermittent Capecitabine
CapecitabineXelodaIntermittent Capecitabine
CapecitabineXelodaMetronomic Capecitabine

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
Intermittent CapecitabineActive ComparatorCapecitabine 1000 mg/m2 twice daily on days 1-14 of each 3 week cycle.
  • Docetaxel plus Capecitabine
  • Capecitabine
Metronomic CapecitabineExperimentalCapecitabine 500 mg/m2 three times daily on days 1-21 of each 3-week cycle
  • Docetaxel plus Capecitabine
  • Capecitabine

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:up to 36 months
Safety Issue:
Description:Time from randomization to progression or death (whichever occurred first).

Secondary Outcome Measures

Measure:Adverse events (AEs)
Time Frame:up to 36 months
Safety Issue:
Description:Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0), premature withdrawals and vital signs. Hand-foot syndrome and diarrhea will be specially interested. Adverse events of special interest: hand-foot syndrome and diarrhea. The estimated HFS rate will be about 60% from intermittent Capecitabine vs about 10% from metronomic Capecitabine, diarrhea rate will be about 50% from intermittent Capecitabine vs about 10% from metronomic Capecitabine.
Measure:Overall survival (OS):
Time Frame:up to 52 months
Safety Issue:
Description:Time from randomization to death
Measure:Overall Response rates (ORR)
Time Frame:up to 36 months
Safety Issue:
Description:Defined as CR+PR, assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase.
Measure:Clinical Benefit rate (CBR)
Time Frame:up to 36 months
Safety Issue:
Description:Defined as CR+PR+SD, assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase
Measure:Time to Progression (TTP)
Time Frame:up to 36 months
Safety Issue:
Description:Time from randomization to disease progression
Measure:QoL
Time Frame:up to 36 months
Safety Issue:
Description:Using the EORTC quality of life questionnaire QLQ-C30

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Binghe Xu

Trial Keywords

  • Metastatic Breast Cancer
  • Antineoplastic Agents
  • Therapeutic Uses
  • Antimetabolites
  • Tubulin Modulators
  • Maintenance chemotherapy
  • Metronomic chemotherapy
  • Capecitabine
  • Docetaxel

Last Updated

November 21, 2013