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

NCT ID: NCT03423849

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-08
• Study Completion Date: 2020-02-08

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).

Conditions

Breast Cancer; Chemotherapy Effect; Disease-free Survival

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 ）

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

25mg/m2,day 1 and day 8, every 3 weeks

Gemcitabine

Intervention Type: DRUG

1250mg/m2,day 1 and day 8, every 3 weeks

Cisplatin

Intervention Type: DRUG

25mg/m2,day 1,every 3 weeks

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.

Group Type: EXPERIMENTAL

Vinorelbine

Intervention Type: DRUG

25mg/m2,day 1 and day 8, every 3 weeks

Capecitabine monotherapy

Capecitabine oral 1250mg/m2,bid,for 6 cycles

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

1250mg/m2,day 1 to day 14, every 3 weeks

Interventions

Vinorelbine

25mg/m2,day 1 and day 8, every 3 weeks

Intervention Type: DRUG

Gemcitabine

1250mg/m2,day 1 and day 8, every 3 weeks

Intervention Type: DRUG

Cisplatin

25mg/m2,day 1,every 3 weeks

Intervention Type: DRUG

Capecitabine

1250mg/m2,day 1 to day 14, every 3 weeks

Intervention Type: DRUG

Other Intervention Names

Anhydmvinblastine; Gemcel; cisplatinum; XELODA

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhiyong Yu

OTHER

Sponsor Role: lead

Responsible Party

Zhiyong Yu

Director of the Breast Surgery Ⅰ

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhiyong Yu, PhD

Role: STUDY_CHAIR

Shandong Cancer Hospital and Institute

Zhaoyun Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Central Contacts

Zhiyong Yu, PhD

Role: CONTACT

drzhiyongyu@aliyun.com

86-13355312277

Zhaoyun Liu, MD

Role: CONTACT

liuzhaoyun99@163.com

86-17865123967

Other Identifiers

ShandongCHI-04

Identifier Type: -

Identifier Source: org_study_id