The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
Prospective Randomized Controlled Study of the Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
1 other identifier
interventional
200
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Feb 2018
Shorter than P25 for phase_2 breast-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2018
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedStudy Start
First participant enrolled
February 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2020
CompletedFebruary 6, 2018
February 1, 2018
2 years
January 1, 2018
February 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival (DFS)
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
5 years
Secondary Outcomes (1)
Overall survival (OS)
5 years
Study Arms (3)
The original program (NG/NP)
EXPERIMENTALVinorelbine 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 ）
One of the original program (N)
EXPERIMENTALVinorelbine 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.
Capecitabine monotherapy
EXPERIMENTALCapecitabine oral 1250mg/m2,bid,for 6 cycles
Interventions
25mg/m2,day 1 and day 8, every 3 weeks
1250mg/m2,day 1 and day 8, every 3 weeks
1250mg/m2,day 1 to day 14, every 3 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhiyong Yulead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhiyong Yu, PhD
Shandong Cancer Hospital and Institute
- PRINCIPAL INVESTIGATOR
Zhaoyun Liu, MD
Shandong Cancer Hospital and Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of the Breast Surgery Ⅰ
Study Record Dates
First Submitted
January 1, 2018
First Posted
February 6, 2018
Study Start
February 8, 2018
Primary Completion
February 8, 2020
Study Completion
February 8, 2020
Last Updated
February 6, 2018
Record last verified: 2018-02