Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer
- Registration Number
- NCT01924078
- Lead Sponsor
- Fudan University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Metronomic Capecitabine and AI aromatase Inhibitors (AIs) 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. Metronomic Capecitabine and AI Capecitabine 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.
- Primary Outcome Measures
Name Time Method adverse events average 10 months adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.)
- Secondary Outcome Measures
Name Time Method TTF average 10 months time to treatment failure（TTF)
PFS average 10 months Progression-free survival (PFS)
Trial Locations
- Locations (1)
FUSCC
🇨🇳Shanghai, Shanghai, China