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

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Aromatase Inhibitors; Capecitabine; Hormones

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.