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

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01924078

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Capecitabine Drug: aromatase Inhibitors (AIs)	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2010

Anticipated Primary Completion Date :

Mar 1, 2015

Anticipated Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metronomic Capecitabine and AI 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 metronomic use: capecitabine 500mg/tid Other Names: Xeloda Drug: aromatase Inhibitors (AIs) Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o. Other Names: Exmestane or Letrozol or Anastrozol

Arm

Intervention/Treatment

Experimental: Metronomic Capecitabine and AI

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

metronomic use: capecitabine 500mg/tid

Other Names:

Xeloda

Drug: aromatase Inhibitors (AIs)

Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o.

Other Names:

Exmestane or Letrozol or Anastrozol

Outcome Measures

Primary Outcome Measures

adverse events [average 10 months]
adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.)

Secondary Outcome Measures

PFS [average 10 months]
Progression-free survival (PFS)
TTF [average 10 months]
time to treatment failure（TTF)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.