Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer

NCT03348098 | Unknown Phase 2

• 1 other identifier: AHEAD TB001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of apatinib in patient with TNBC

Conditions

Triple Negative Breast Cancer

Keywords

Triple negative breast cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  ten months

Secondary Outcomes (4)

• DCR

  ten months

• pCR

  ten months

• DFS

  ten months

• Incidence of Treatment-Emergent Adverse Events [Safety]

  ten months

Study Arms (1)

single arm

EXPERIMENTAL

Apatinib Combined With Paclitaxel in Neoadjuvant Therapy of Locally Advanced Exploratory Research on Single-arm of TNBC

Drug: Apatinib; Drug: Paclitaxel

Interventions

Apatinib DRUG

500 mg, po, qd. 12weeks

Also known as: YN968D1

single arm

Paclitaxel DRUG

drug: Paclitaxel ,80mg/m2, d1, Once a week , A total of 12 weeks; 3 weeks as a cycle

Also known as: Taxol

single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients between18 and 75 Years old;
• patients with locally advanced breast cancer (TNM periodization:T is equal to or greater than 2,N is equal to 1,M is equal to 0)
• clear for immunohistochemical is that: estrogen receptor-negative (ER-), progesterone receptor-negative (PR-), the human epidermal growth factor receptor 2 is Negative ( IHC Her-2 0/+ , If ER- 、 PR- But Her-2 ++ , You need to do FISH/CISH Testing confirmed that Her-2 Amplification is negative);
• The ECOG score is between 0 to 2 points;
• The expected lifetime is ≥3 months;
• Major organ function is normal, that meet the following criteria:
• Blood test standards subject to:
• HB≥90 g/L ;
• ANC≥1.5×109 /L ;
• PLT≥100×109 /L ;
• Biochemical examination must meet the following criteria:
• TBIL≤1.5xULN ( upper limit of normal value ) ;
• ALT AST≤2.5×ULN ;
• Serum Cr≤1.5×ULN And endogenous creatinine clearance rate ≥50 mL/min (Cockcroft-Gault formula ) ;
• the women of childbearing age must do the pregnancy test ( serum or urine ) within 7 days when they are included in the trial, And the result was negative, and during the trial and at the time of giving experimental drugs after 8 weeks using the appropriate methods of contraception;

You may not qualify if:

• patients with pregnancy or lactation;
• inflammatory breast cancer patients;
• patients with several factors affecting medication (for example, inability to swallow, such as nausea, vomiting, chronic diarrhea, and bowel obstruction);
• injury or pathologic fracture;
• people with high blood pressure and antihypertensive drug treatment could not be reduced to within the normal range (systolic \>140 mmHg, diastolic pressure \>90 mmHg) ;
• with ⅱ grade myocardial ischemia, poor control of arrhythmias or myocardial infarction (including QTc interval men ≥450 Ms, female ≥470 Ms);
• according to NYHA standard ⅲ\~ⅳ -class heart insufficiency or heart ultrasound: LVEF(left ventricular ejection fraction) \<50%;
• the past 6 months have gastrointestinal bleeding within history or definite gastrointestinal bleeding, such as: risk of bleeding oesophageal varicose ulcer lesions, fecal occult blood, local activities ≥ (++) Into groups; such as the fecal occult blood (+), requires endoscopy;
• prior to participating in the study of 28 days abdominal fistula, perforation of the gastrointestinal tract and abdominal abscesses;
• positive patients of urinary protein (urine protein 2+ or above, or 24 -hour urine protein \> 1.0g);
• distant metastasis of patients with symptoms or are not controlled;
• expected lifetime \< 3 months;
• into the group before 28 days to accept other anticancer treatment;
• other information: dysfunction of blood coagulation (INR\>1.5 or prothrombin time ( PT )\> ULN+4 Seconds); Anticoagulant therapy are receiving antithrombotic or infection who needed intravenous antibiotics; previously receiving bevacizumab treatment or other anti- VEGF TKI Drug treatment, with a second tumor (except basal cell carcinoma and cervical carcinoma in situ);
• a history of immunodeficiency, including HIV testing positive, or suffer from other acquired, congenital immune deficiency disease or have a history of organ transplantation;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

TianJin Medical University Cancer Institute and Hospital

Tianjin, 300060, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

apatinib; Paclitaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Hong MD Liu

  study principal investigator

  STUDY CHAIR

Central Study Contacts

Hong MD Liu, professor

CONTACT

18622221169; lh713@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 20, 2017
• Study Start: September 6, 2017
• Primary Completion: July 6, 2018
• Study Completion: December 6, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-09

Locations

CN (1)