Clinical trial NCT01924078: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
metronomic chemotherapy
aromatase inhibitors
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: adverse events
timeFrame: average 10 months
Secondary outcomes:
measure: PFS
timeFrame: average 10 months
measure: TTF
timeFrame: average 10 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: FUSCC
state: Shanghai
Study officials:
affiliation: Fudan University
name: Guang-yu Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.