Actively Recruiting
A Study of the Addition of Metronomic Capecitabine to Standard Adjuvant Therapy in High Risk HER2+ BC paTients
Led by Sun Yat-sen University · Updated on 2018-07-26
794
Participants Needed
1
Research Sites
544 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Breast cancer is the most common malignant tumor in women. Recurrent or metastatic breast cancer is incurable. High risk patients usually have the following characteristics, such as, non-pCR after neoadjuvant therapy, lymph nodes positive, \>2cm tumor size, HER2 overexpression, etc. Intensive targeted or chemo therapy could improve prognosis. Previous studies have shown the efficacy and feasibility of intensive treatment of capecitabine in non-pCR breast cancer patients. Given the metronomic capecitabine therapy is well tolerated, we designed this study to compare the efficacy and safety of adding metronomic capecitabine to standard adjuvant therapy for high risk HER2+ breast cancer patients.
CONDITIONS
Official Title
A Study of the Addition of Metronomic Capecitabine to Standard Adjuvant Therapy in High Risk HER2+ BC paTients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Early stage operable HER2-positive primary breast cancer
- Histologically confirmed invasive breast carcinoma
- High risk patients with residual invasive lesions after neoadjuvant treatment (non-pCR), positive lymph nodes, or tumor size greater than 2 cm
- If neoadjuvant treatment given, at least 6 cycles of chemotherapy over at least 16 weeks, including at least 9 weeks of trastuzumab and 9 weeks of taxane-based chemotherapy
- Adequate surgical excision of all clinically evident disease in breast and lymph nodes
- Known hormone receptor status
- Signed informed consent approved by Institutional Review Board or Ethical Committee
- Age 18 to 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function as defined by specific blood counts, liver and kidney tests, and heart function (LVEF 50%)
- Agreement to use effective contraception or remain abstinent if not postmenopausal or surgically sterile
- Negative pregnancy test for premenopausal women
- Documentation of hepatitis B and C serologies within 3 months prior to neoadjuvant therapy or during screening
You will not qualify if you...
- Stage IV (metastatic) breast cancer
- History of any prior breast cancer except lobular carcinoma in situ
- Clinically evident residual or recurrent disease after preoperative therapy and surgery
- Progressive disease after preoperative systemic therapy
- Treatment with investigational anti-cancer drugs within 28 days before study treatment
- History of other malignancies within 5 years except certain treated cancers
- Contraindications to radiotherapy for breast cancer
- Current peripheral neuropathy grade 2 or higher
- History of high cumulative doses of anthracyclines
- Cardiopulmonary dysfunction including severe heart failure, uncontrolled arrhythmias, or significant cardiac symptoms
- History of LVEF below 40% with prior trastuzumab
- Uncontrolled high blood pressure
- Evidence of transmural infarction on ECG
- Requirement for continuous oxygen therapy
- Severe uncontrolled systemic diseases
- Current pregnancy or breastfeeding
- Major unrelated surgery or significant injury within 28 days before randomization
- Active liver disease or uncontrolled hepatitis
- Serious infections or HIV infection
- History of severe hypersensitivity to trastuzumab or related products
- Active unresolved infections at screening
- Investigator assessment of inability or unwillingness to comply with protocol requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shusen Wang
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
S
Shusen Wang, MD
CONTACT
W
Wen Xia, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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