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

• ClinicalTrials.gov Identifier: NCT03423849
• Recruitment Status: Unknown
• First Posted: February 6, 2018
• Last Update Posted: February 6, 2018
• Sponsor: Zhiyong Yu
• Information provided by (Responsible Party): Zhiyong Yu, Shandong Cancer Hospital and Institute

Tracking Information

• First Submitted Date: January 1, 2018
• First Posted Date: February 6, 2018
• Last Update Posted Date: February 6, 2018
• Estimated Study Start Date: February 8, 2018
• Estimated Primary Completion Date: February 8, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Breast Cancer
• Chemotherapy Effect
• Disease-free Survival

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 5, 2018): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 8, 2020
• Estimated Primary Completion Date: February 8, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03423849
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Zhiyong Yu, Shandong Cancer Hospital and Institute
• Study Sponsor: Zhiyong Yu
• Collaborators: Not Provided

Investigators

• 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