Breast Cancer
Conditions
Keywords
breast cancer, metronomic chemotherapy, aromatase inhibitors
Brief summary
The present study is to determine the adverse effects and clinical efficacy of AI combined with Capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with Estrogen receptor and/or Progestrogen receptor positive.
Detailed description
Capecitabine (Xeloda ®) is currently the most biologically active oral fluoropyrimidine drug, and is widely used as first-line and second-line rescue therapy for advanced breast cancer ,third-generation aromatase inhibitors (AI) is the preferred adjuvant endocrine therapy for Postmenopausal hormone-sensitive breast cancer. Study showed that AI combined with metronomic chemotherapy could improve the objective response and clinical benefit in neoadjuvant therapy.
Interventions
Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o.
DRUGCapecitabine
metronomic use: capecitabine 500mg/tid
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Hormone receptor positive; 2. previously untreated patients who do not receive hormonal therapy, or initial endocrine treatment failure or first -line endocrine treatment of relapse and metastasis failure; 3. patients who do not receive hormonal therapy must be histologically confirmed invasive ductal carcinoma, can be surgery, but must be satisfied one of the following: (1) elderly (≥70 years), or with severe heart or other systemic complications, belonging to high risk of general anesthesia, (2) have will of conserving the breast,but larger tumors (≥3cm) not suitable for breast-conserving surgery. 4. patients with metastatic breast cancer must have evaluable lesions 5. normal laboratory values: 6. informed consent (ethical approval document No. :1112105-1); 7. life expectancy of at least 3 months; 8. Postmenopausal or premenopausal with bilateral oophorectomy.
Exclusion criteria
1. have had radiotherapy or other local treatment for measurable lesions before the start of study received within 3 months 2. organ transplant (except for autologous or allogeneic bone marrow transplantation); 3. have evidences of central nerve system metastases or have a history of mental illness that uncontrol; 4. unable to swallow tablets, or malabsorption patients, or patients with poor upper gastrointestinal integrity; 5. unwilling or unable to comply with study protocol or unable to meet the follow up; 6. patients who researchers considered were not suitable to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | average 10 months | adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | average 10 months | Progression-free survival (PFS) |
| TTF | average 10 months | time to treatment failure（TTF) |
Countries
China
Contacts
Primary ContactGuang-Yu Liu, MD
Backup ContactJian-wei Li, MD
Outcome results
None listed