Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Capecitabine Metronomic Chemotherapy Combined With Aromatase Inhibitors in Postmenopausal Hormone-receptor-positive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Capecitabine
* Drug: aromatase Inhibitors (AIs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hormone receptor positive; previously untreated patients who do not receive hormonal therapy, or initial endocrine treatment failure or first -line endocrine treatment of relapse and metastasis failure; 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. patients with metastatic breast cancer must have evaluable lesions normal laboratory values: informed consent (ethical approval document No. :1112105-1); life expectancy of at least 3 months; Postmenopausal or premenopausal with bilateral oophorectomy. Exclusion Criteria: have had radiotherapy or other local treatment for measurable lesions before the start of study received within 3 months organ transplant (except for autologous or allogeneic bone marrow transplantation); have evidences of central nerve system metastases or have a history of mental illness that uncontrol; unable to swallow tablets, or malabsorption patients, or patients with poor upper gastrointestinal integrity; unwilling or unable to comply with study protocol or unable to meet the follow up; patients who researchers considered were not suitable to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metronomic Capecitabine and AI<br>Postmenopausal Hormone receptor positive breast cancer patients who wanted to conserve breast were enrolled to receive capecitabine 500mg/tid p.o plus one of the aromatase inhibitors (AIs):Anastrozole 1mg/day p.o, and who had first line or second line Letrozole therapy failure were switched to capecitabine 500mg/tid p.o plus Exemestane 25mg/day p.o；or Exemestane therapy failure were switched to capecitabine 500mg/tid p.o plus Letrozole 2.5mg/day p.o. | Drug: Capecitabine<br>* metronomic use: capecitabine 500mg/tid<br>* Other names: Xeloda;Drug: aromatase Inhibitors (AIs)<br>* Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o.<br>* Other names: Exmestane or Letrozol or Anastrozol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.) | average 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival (PFS) | average 10 months | 
| TTF | time to treatment failure（TTF) | average 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, metronomic chemotherapy, aromatase inhibitors