Clinical Trials /

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

NCT03243838

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer
  • Official Title: A Open-label, Prospective, Phase 1b Trial of Neoadjuvant Chemotherapy Combined With Small Dose of Apatinib in the Treatment of Early Triple-negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 20170328
  • NCT ID: NCT03243838

Conditions

  • Triple-Negative Breast Cancer

Interventions

DrugSynonymsArms
ApatinibExperimental Group

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Experimental GroupExperimentalFour cycles of docetaxel combined with apatinib followed by four cycles of epirubicin and cyclophosphamide as Neoadjuvant Treatment for Triple-Negative Breast Cancer
  • Apatinib

Eligibility 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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:pCR
Time Frame:one year
Safety Issue:
Description:pathologic complete response

Secondary Outcome Measures

Measure:OS
Time Frame:twenty years
Safety Issue:
Description:overall survival

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Guangdong General Hospital

Trial Keywords

  • Triple-Negative Breast Cancer
  • apatinib
  • pCR
  • OS
  • Neoadjuvant chemotherapy

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