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The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy

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ClinicalTrials.gov Identifier: NCT03423849
Recruitment Status : Unknown
Verified February 2018 by Zhiyong Yu, Shandong Cancer Hospital and Institute.
Recruitment status was:  Not yet recruiting
First Posted : February 6, 2018
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Zhiyong Yu, Shandong Cancer Hospital and Institute

Tracking Information
First Submitted Date  ICMJE January 1, 2018
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date February 6, 2018
Estimated Study Start Date  ICMJE February 8, 2018
Estimated Primary Completion Date February 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
Disease-free survival (DFS) [ Time Frame: 5 years ]
To determine the percentage of disease-free survival (DFS) for the The original program (NG/NP) or One of the original program (N) or Capecitabine monotherapy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
Overall survival (OS) [ Time Frame: 5 years ]
To determine the percentage of Overall survival (OS) for the The original program (NG/NP) or One of the original program (N) or Capecitabine monotherapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
Official Title  ICMJE Prospective Randomized Controlled Study of the Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
Brief Summary Worldwide, breast cancer is the most incident and prevalent cancer among women. Despite advances in the treatment of advanced breast cancer (ABC) during the past decade, adjuvant systemic therapy has yield little progression for such patients. ABC remains an incurable disease, responsible for approximate 40,000 deaths annually and a median life expectancy of no more than 3 years. The NCCN guidelines clearly define routine adjuvant chemotherapy regimens for the early breast cancer, however, for the patients with recurrence and metastasis, the choice of treatment options is not clear. In this trial, we choose the patients with disease progression who received anthracycline and taxane adjuvant chemotherapy after surgery. The patients received vinorelbine and gemcitabine (NG) or vinorelbine and platinum (NP) regiments for 6 cycles. Then the patients with complete response (CR), partly response (PR) and stable disease(SD) will be assigned to 3 groups, one group will receive the original regiment for 3 cycles to maintain treatment, one group will receive the vinorelbine for 6 cycles, the other group will receive the capecitabine for 6 cycles. Trasuzumab will be used to patients if HER-2 positive. Endocrine therapy will be used if the hormone receptors positive after the chemotherapy. The primary endpoint is to assess disease-free survival (DFS), the secondary endpoint is to assess the overall survival (OS).
Detailed Description The trial is designed to help us to choose the maintain treatment regiment for the patients with effective first-line salvage therapy. After inorelbine and gemcitabine (NG) or vinorelbine and platinum (NP) regiments for 6 cycles, patients will be assess the effect of treatment. As for the patients with complete response (CR), partly response (PR) and stable disease(SD), the investigators will randomly assign them to receive 3 cycles of original regiment, or 6 cycles of vinorelbine, or 6 cycles of capecitabine. Trasuzumab will be used to patients if HER-2 positive. Endocrine therapy will be used if the hormone receptors positive after the chemotherapy. The effectiveness of therapy will be estimated after the maintain therapy. The first two years the patient was prescribed every 3 months to review the disease, then review the disease every six months. The primary endpoint is to assess disease-free survival (DFS), the secondary endpoint is to assess the overall survival (OS).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Chemotherapy Effect
  • Disease-free Survival
Intervention  ICMJE
  • Drug: Vinorelbine
    25mg/m2,day 1 and day 8, every 3 weeks
    Other Name: Anhydmvinblastine
  • Drug: Gemcitabine
    1250mg/m2,day 1 and day 8, every 3 weeks
    Other Name: Gemcel
  • Drug: Cisplatin
    25mg/m2,day 1,every 3 weeks
    Other Name: cisplatinum
  • Drug: Capecitabine
    1250mg/m2,day 1 to day 14, every 3 weeks
    Other Name: XELODA
Study Arms  ICMJE
  • Experimental: The original program (NG/NP)
    Vinorelbine injection 25mg/m2 on day 1 and day 8, Gemcitabine injection 1250mg/m2 on day1 and day 8,every 3 weeks for 3 cycles(for the patients who used the NG salvage therapy) or Vinorelbine injection 25mg/m2 on day 1 and day 8,Cisplatin injection 25mg/m2 on day1,every 3 weeks for 3 cycles(for the patients who used the NP salvage therapy )
    Interventions:
    • Drug: Vinorelbine
    • Drug: Gemcitabine
    • Drug: Cisplatin
  • Experimental: One of the original program (N)
    Vinorelbine injection,25mg/m2 on day 1 and day 8,every 3 weeks for 6 cycles. or, Vinorelbine oral 60mg/m2 on day 1,every week for 6 cycles.
    Intervention: Drug: Vinorelbine
  • Experimental: Capecitabine monotherapy
    Capecitabine oral 1250mg/m2,bid,for 6 cycles
    Intervention: Drug: Capecitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 5, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 8, 2020
Estimated Primary Completion Date February 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients were required to give written informed consent.
  • Patients with distant metastasis who primary received anthracycline and taxane adjuvant chemotherapy after surgery.
  • After inorelbine and gemcitabine (NG) or vinorelbine and platinum (NP) regiments for 6 cycles,patients were assessed the effect of treatment. As for the patients with complete response (CR), partly response (PR) and stable disease(SD).
  • Have normal cardiac functions by echocardiography
  • ECOG scores are ≤ 0-1.
  • Patients are disposed to practice contraception during the whole trial.
  • The results of patients' blood tests are as follows:

Hb ≥ 90 g/L WBC ≥ 3.0×109/L Plt ≥ 100×109/L Neutrophils ≥ 1.5×109/L ALT and AST ≤ 2.5 times of normal upper limit. TBIL ≤ 1.5 times of normal upper limit. Creatinine ≤ 1.5 times of normal upper limit.

Exclusion Criteria:

  • Have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
  • Active infections.
  • Severe non-cancerous diseases.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03423849
Other Study ID Numbers  ICMJE ShandongCHI-04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhiyong Yu, Shandong Cancer Hospital and Institute
Study Sponsor  ICMJE Zhiyong Yu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhiyong Yu, PhD Shandong Cancer Hospital and Institute
Principal Investigator: Zhaoyun Liu, MD Shandong Cancer Hospital and Institute
PRS Account Shandong Cancer Hospital and Institute
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP