Overview

Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer

Status:
Unknown status
Trial end date:
2019-12-30
Target enrollment:
0
Participant gender:
Female
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 to improve postoperative pathologic complete response(pCR)of neoadjuvant chemotherapy is critical problem to prolong overall survival (OS) of TNBC patients. Apatinib is a new oral small molecule tyrosine protease inhibitor, it is effective in inhibiting angiogenesis with a very low concentration. So the standard neoadjuvant chemotherapy regimen of docetaxel and carboplatin combined with apatinib may improve the postoperative PCR and OS of TNBC patients. Safety and tolerability assessed by number of grade 3 and 4 toxicities and hospitalizations.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Guangdong General Hospital
Guangdong Provincial People's Hospital
Treatments:
Apatinib
Carboplatin
Docetaxel
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.