Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer
Keywords
Abstract
Dates
| Last Verified: | 01/31/2018 |
| First Submitted: | 08/04/2017 |
| Estimated Enrollment Submitted: | 08/07/2017 |
| First Posted: | 08/08/2017 |
| Last Update Submitted: | 02/02/2018 |
| Last Update Posted: | 02/05/2018 |
| Actual Study Start Date: | 04/01/2018 |
| Estimated Primary Completion Date: | 12/29/2019 |
| Estimated Study Completion Date: | 12/29/2019 |
Condition or disease
Intervention/treatment
Drug: Experimental Group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Experimental Group Four cycles of docetaxel combined with apatinib followed by four cycles of epirubicin and cyclophosphamide as Neoadjuvant Treatment for Triple-Negative Breast Cancer | Drug: Experimental Group docetaxel/carboplatin combined with apatinib as Neoadjuvant Treatment for Triple-Negative Breast Cancer |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: Histologically or cytologically confirmed Triple-Negative invasive breast carcinoma - Clinical stageIIA-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 neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3 Total bilirubin < upper limit of normal Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility - Patients must be over 18 years old - 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 Criteria: - 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. |
Outcome
Primary Outcome Measures
1. pCR [one year]
Secondary Outcome Measures
1. OS [twenty years]
