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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

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Chemotherapy Effect Disease-free Survival Drug: Vinorelbine Drug: Gemcitabine Drug: Cisplatin Drug: Capecitabine Phase 2 Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Study of the Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
Estimated Study Start Date : February 8, 2018
Estimated Primary Completion Date : February 8, 2020
Estimated Study Completion Date : February 8, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 )
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

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.
Drug: Vinorelbine
25mg/m2,day 1 and day 8, every 3 weeks
Other Name: Anhydmvinblastine

Experimental: Capecitabine monotherapy
Capecitabine oral 1250mg/m2,bid,for 6 cycles
Drug: Capecitabine
1250mg/m2,day 1 to day 14, every 3 weeks
Other Name: XELODA




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423849


Contacts
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Contact: Zhiyong Yu, PhD 86-13355312277 drzhiyongyu@aliyun.com
Contact: Zhaoyun Liu, MD 86-17865123967 liuzhaoyun99@163.com

Sponsors and Collaborators
Zhiyong Yu
Investigators
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Study Chair: Zhiyong Yu, PhD Shandong Cancer Hospital and Institute
Principal Investigator: Zhaoyun Liu, MD Shandong Cancer Hospital and Institute
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Responsible Party: Zhiyong Yu, Director of the Breast Surgery Ⅰ, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03423849    
Other Study ID Numbers: ShandongCHI-04
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Vinorelbine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators