To hear about similar clinical trials, please enter your email below
Trial Title:
Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer
NCT ID:
NCT01924078
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Capecitabine
Aromatase Inhibitors
Conditions: Keywords:
breast cancer
metronomic chemotherapy
aromatase inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
metronomic use: capecitabine 500mg/tid
Arm group label:
Metronomic Capecitabine and AI
Other name:
Xeloda
Intervention type:
Drug
Intervention name:
aromatase Inhibitors (AIs)
Description:
Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o.
Arm group label:
Metronomic Capecitabine and AI
Other name:
Exmestane or Letrozol or Anastrozol
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:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
FUSCC
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Guang-Yu Liu, MD
Phone:
86-021-64175590
Phone ext:
8808
Email:
liugy123@yahoo.com
Start date:
October 2010
Completion date:
June 2015
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01924078
