Back to resultsCapecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine
aromatase Inhibitors (AIs)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, metronomic chemotherapy, aromatase inhibitors
Eligibility Criteria
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.
Sites / Locations
- FUSCCRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metronomic Capecitabine and AI
Arm Description
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.
Outcomes
Primary Outcome Measures
adverse events
adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.)
Secondary Outcome Measures
PFS
Progression-free survival (PFS)
TTF
time to treatment failure（TTF)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01924078
Brief Title
Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer
Official Title
Capecitabine Metronomic Chemotherapy Combined With Aromatase Inhibitors in Postmenopausal Hormone-receptor-positive Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, metronomic chemotherapy, aromatase inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metronomic Capecitabine and AI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
metronomic use: capecitabine 500mg/tid
Intervention Type
Drug
Intervention Name(s)
aromatase Inhibitors (AIs)
Other Intervention Name(s)
Exmestane or Letrozol or Anastrozol
Intervention Description
Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o.
Primary Outcome Measure Information:
Title
adverse events
Description
adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.)
Time Frame
average 10 months
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-free survival (PFS)
Time Frame
average 10 months
Title
TTF
Description
time to treatment failure（TTF)
Time Frame
average 10 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guang-Yu Liu, MD
Phone
86-021-64175590
Ext
8808
Email
liugy123@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-wei Li, MD
Phone
86-021-64175590
Ext
8808
Email
doctorljw@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang-yu Liu, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
FUSCC
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guang-Yu Liu, MD
Phone
86-021-64175590
Ext
8808
Email
liugy123@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
30361875
Citation
Li JW, Zuo WJ, Ivanova D, Jia XQ, Lei L, Liu GY. Metronomic capecitabine combined with aromatase inhibitors for new chemoendocrine treatment of advanced breast cancer: a phase II clinical trial. Breast Cancer Res Treat. 2019 Jan;173(2):407-415. doi: 10.1007/s10549-018-5024-3. Epub 2018 Oct 25.
Results Reference
derived
Learn more about this trial
Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer
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