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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01924078
• Other study ID #: Metronomic Therapy
• Status: Recruiting
• Phase: Phase 2
• First received: August 9, 2013
• Last updated: August 14, 2013
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: August 2013
• Source: Fudan University
• Contact: Guang-Yu Liu, MD
• Phone: 86-021-64175590
• Email: liugy123[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Capecitabine
metronomic use: capecitabine 500mg/tid
• aromatase Inhibitors (AIs)
Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o.

Locations

Country	Name	City	State
China	FUSCC	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events	adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.)	average 10 months	Yes
Secondary	PFS	Progression-free survival (PFS)	average 10 months	No
Secondary	TTF	time to treatment failure(TTF)	average 10 months	No