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

Sponsor
Zhiyong Yu
Study ID
NCT03423849
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    25mg/m2,day 1 and day 8, every 3 weeks
  • Gemcitabine — DRUG
    1250mg/m2,day 1 and day 8, every 3 weeks
  • Cisplatin — DRUG
    25mg/m2,day 1,every 3 weeks
  • Capecitabine — DRUG
    1250mg/m2,day 1 to day 14, every 3 weeks

Study Details

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).

Key Dates

Start date
Feb 8, 2018
Status verified
Feb 2018
Primary completion
Feb 8, 2020
Completion
Feb 8, 2020

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 ）
  • 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.
  • Experimental: Capecitabine monotherapy
    Capecitabine oral 1250mg/m2,bid,for 6 cycles

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: 5 years ]

Central Contacts

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