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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03243838
Recruitment Status : Not yet recruiting
First Posted : August 9, 2017
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
KunWang, Guangdong General Hospital

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 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.

Condition or disease Intervention/treatment Phase
Triple-Negative Breast Cancer Drug: Apatinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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: Apatinib
docetaxel/carboplatin combined with apatinib as Neoadjuvant Treatment for Triple-Negative Breast Cancer

Primary Outcome Measures :
  1. pCR [ Time Frame: one year ]
    pathologic complete response

Secondary Outcome Measures :
  1. OS [ Time Frame: twenty years ]
    overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03243838

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Contact: Kun Wang 00862083827812 ext 80632
Contact: Ciqiu Yang 00862083827812 ext 80631

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China, Guangdong
Guangdong general hospital Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Liming Yao    00862083827812 ext 20984   
Sponsors and Collaborators
Guangdong General Hospital

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Responsible Party: KunWang, Professor, Guangdong General Hospital Identifier: NCT03243838     History of Changes
Other Study ID Numbers: 20170328
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by KunWang, Guangdong General Hospital:
Triple-Negative Breast Cancer
Neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action