Status:
COMPLETED
Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Triple-Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
Triple-negative breast cancer (TNBC) is a special type of breast cancer, endocrine therapy and targeted therapy are completely ineffective, chemotherapy is currently the only effective treatment. How ...
Detailed Description
All enrolled patients were administered oral apatinib at a dose of 250 mg once daily and intravenously docetaxel (100 mg/m2) every three weeks for four cycles, followed by epirubicin (90 mg/m2) plus c...
Eligibility Criteria
Inclusion
- Histologically or pathologically confirmed noninflammatory Triple-Negative invasive breast carcinoma (TNBC). The diagnosis of TNBC was defined below: the estrogen receptor and progesterone receptor negativity rates were less than 10%, and the human epidermal growth factor receptor type 2 (HER2) staining was 0 or 1+, and fluorescence in situ hybridization (FISH) detected no HER2 gene amplification
- Clinical stage IIA-IIIB
- Patients must have measurable disease as defined by palpable lesion with caliper and/or a positive mammogram or ultrasound. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, x-rays and scans must be done within 28 days of study entry.
- Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- Signed informed consent
- Adequate organ function within 2 weeks of study entry: Absolute bone marrow function (hemoglobin concentration of ≥8.0 g/dL, white blood cell count of ≥3000 cells per μL, absolute neutrophil count of ≥1500 cells per μL, platelet count of ≥70000 cells per μL), adequate renal function (creatinine was the upper limit of normal or lower), and adequate liver function (total bilirubin was the upper limit of normal or lower, and aspartate aminotransferase or alanine aminotransferase was twice the upper limit of normal or lower)
- Patients must be aged 18-70 years
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.
Exclusion
- Metastatic disease
- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone
- History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible
- Uncontrolled blood pressure, previous exposure to apatinib, known allergies to any of the excipients, and a history of unstable angina, myocardial infarction, or class III/IV congestive heart failure (defined by the New York Heart Association) within the past 6 months before day 1 of the trial
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03243838
Start Date
August 1 2018
End Date
December 31 2021
Last Update
February 2 2022
Active Locations (2)
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1
Guangdong general hospital
Guangzhou, Guangdong, China, 510080
2
Guangdong General Hospital
Guangzhou, China