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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: aromatase Inhibitors (AIs); Drug: Capecitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01924078

Metronomic Therapy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Metronomic Capecitabine and AI

Experimental group

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.

Treatment:

Drug: aromatase Inhibitors (AIs)

Drug: Capecitabine