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Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, metronomic chemotherapy, aromatase inhibitors
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Capecitabine
Type: Drug
Name: aromatase Inhibitors (AIs)
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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.
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.
Location
FUSCC
Shanghai, Shanghai, China
Status: Recruiting
Contact: Guang-Yu Liu, MD - 86-021-64175590 - liugy123@yahoo.com
Start Date
October 2010
Completion Date
June 2015
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page