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

Breast Cancer Clinical Trial

Official title:

Prospective Randomized Controlled Study of the Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03423849
• Other study ID #: ShandongCHI-04
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: January 1, 2018
• Last updated: February 5, 2018
• Start date: February 8, 2018
• Est. completion date: February 8, 2020

Study information

• Verified date: February 2018
• Source: Shandong Cancer Hospital and Institute
• Contact: Zhiyong Yu, PhD
• Phone: 86-13355312277
• Email: drzhiyongyu[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 8, 2020
• Est. primary completion date: February 8, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy Effect
• Disease-free Survival

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhiyong Yu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	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	5 years