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Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC (CAMELLIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Chinese Academy of Medical Sciences
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Binghe Xu, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01917279
First received: July 19, 2013
Last updated: November 21, 2013
Last verified: November 2013
  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).


Condition Intervention Phase
Breast Neoplasms
Neoplasms by Site
Neoplasm Metastasis
Breast Diseases
Skin Diseases
Drug: Docetaxel plus Capecitabine
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    Time from randomization to progression or death (whichever occurred first).


Secondary Outcome Measures:
  • Adverse events (AEs) [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]

    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.


  • Overall survival (OS): [ Time Frame: up to 52 months ] [ Designated as safety issue: No ]
    Time from randomization to death

  • Overall Response rates (ORR) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    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.

  • Clinical Benefit rate (CBR) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    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

  • Time to Progression (TTP) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    Time from randomization to disease progression

  • QoL [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    Using the EORTC quality of life questionnaire QLQ-C30


Estimated Enrollment: 928
Study Start Date: October 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intermittent Capecitabine
Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3 week cycle.
Drug: Docetaxel plus Capecitabine
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.
Drug: Capecitabine
Capecitabine 500 mg/m2 three times daily on days 1-21 of each 3-week cycle
Other Name: Xeloda
Experimental: Metronomic Capecitabine
Capecitabine 500 mg/m2 three times daily on days 1-21 of each 3-week cycle
Drug: Docetaxel plus Capecitabine
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.
Drug: Capecitabine
Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3 week cycle
Other Name: Xeloda

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01917279

Contacts
Contact: Binghe Xu, MD, PhD +86-10-87788826 xubinghe@medmail.com.cn
Contact: Fei Ma, MD +86-13910217780 mafei2011@139.com

Locations
China
Cancer Institute and Hospital, Chinese Academy Of Medical Sciences Recruiting
Beijing, China, 100021
Contact: Binghe Xu, MD, PhD    +86-10-87788826    xubinghe@medmail.com.cn   
Contact: Fei Ma, MD    +86-13910217780    mafei2011@139.com   
Principal Investigator: Binghe Xu, MD, PhD         
Sub-Investigator: Fei Ma, MD         
Sponsors and Collaborators
Binghe Xu
Hoffmann-La Roche
Investigators
Principal Investigator: Binghe Xu, MD, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Binghe Xu, Director of Medical Department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01917279     History of Changes
Other Study ID Numbers: ML28898
Study First Received: July 19, 2013
Last Updated: November 21, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Metastatic Breast Cancer
Antineoplastic Agents
Therapeutic Uses
Antimetabolites
Tubulin Modulators
Maintenance chemotherapy
Metronomic chemotherapy
Capecitabine
Docetaxel

Additional relevant MeSH terms:
Skin Diseases
Breast Diseases
Breast Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Capecitabine
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 23, 2014