NCT03735082

Brief Summary

The purpose of this study is to assess the efficacy and safety of Apatinib Combined With Paclitaxel and Carbopatin Intensive Regimen in Neoadjuvant Therapy for Locally Advanced Triple-negative Breast patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

November 5, 2018

Last Update Submit

November 7, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • pCR rate

    pCR defined as no invasive and non-invasive (DCIS) residuals in breast and armpit lymph nodes

    3 months

  • safety of treatment: Incidence of adverse events

    Incidence of adverse events by maximum CTCAE grade (v4.03; NCI 2010)

    every 2 weeks

Secondary Outcomes (3)

  • rate of breast-pCR

    3 months

  • DFS

    up to 2 years

  • Rate of breast conserving surgery

    3 months

Study Arms (1)

apatinib+Paclitaxel+Carboplatin

EXPERIMENTAL

apatinib 250mg, d1-14,14day/cycle; Paclitaxel 175mg/m2,d1,14days/cycle; Carboplatin AUC=4,d1,14day/cycle

Drug: ApatinibDrug: PaclitaxelDrug: Carboplatin

Interventions

ApatinibDRUG

apatinib 250mg,qd,d1-14,14day/cycle

apatinib+Paclitaxel+Carboplatin
PaclitaxelDRUG

paclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle

apatinib+Paclitaxel+Carboplatin
CarboplatinDRUG

carboplatin AUC=4,d1,14day/cycle;

apatinib+Paclitaxel+Carboplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 year-old women;
  • Physical condition ECOG PS: 0-1;
  • Previously untreated, histologically or cytologically confirmed to be triple negative breast cancer;
  • Breast mass \> 2cm, or ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicle); Note: According to RECIST version 1.1, confirmed by CT or MRI,There must be at least one measurable lesion;If the target lesion is a lymph node requiring a short diameter greater than 1.5 cm, and the target lesion is not suitable for surgical treatment;
  • Laboratory tests meet the following criteria: absolute count of blood neutrophils (ANC) ≥1.5×109/L; platelet (PLT)≥100×109/L; hemoglobin (HB)≥10g/dl; serum bilirubin ≤ 1.5 times the upper limit of normal value; AKP,ALT and AST≤2.5 times the upper limit of normal value;AKP, ALT and AST≤5 times the upper limit of normal value when liver metastasis;Urea nitrogen ≤ 1.5 times the upper limit of normal value,serum creatinine ≤ 1.5 times the upper limit of normal value;
  • Expected survival time ≥ 3 months;
  • Women of child-bearing age should be carried out pregnancy test (serum or urine) within 7 days before recruit, the results should be negative; and are willing to adopt the appropriate methods of contraception during the trial;
  • Patients volunteered to join the study and signed informed consent.

You may not qualify if:

  • There are other metastasis sites other than ipsilateral lymph node metastasis (ipsilateral armpit, internal mammary, supraclavicular);
  • Have received anti-tumor treatment;
  • Patients with hypertension who are not well controlled by antihypertensive medication (systolic pressure \>140 mmHg, diastolic pressure \>90 mmHg); have uncontrolled or severe cardiovascular disease, such as Refractory angina pectoris,congestive heart failure occurred within 6 months prior to screening ; myocardial infarction occurred within 12 months before screening; any clinically significant ventricular arrhythmia history, prolonged QT interval; history of cerebrovascular accident, symptomatic and medication required Coronary heart disease;
  • Significant clinical dysfunction of the digestive tract may affect the intake, transport or absorption of oral medications (eg, inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
  • Patients with previous bleeding history, clinically significant bleeding symptoms, and patients with clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood + and above, vasculitis, etc.; urine protein positive patients;
  • Major surgery or severe traumatic injury, fracture, or poor healing wound within 4 weeks;
  • Allergic to apatinib and/or its adjuvants, paclitaxel, carboplatin, etc.;
  • Female patients during pregnancy or lactation, female patients with fertility and pregnancy test positive, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period
  • The patient has a severe concomitant disease, or any other condition the investigator believes is not suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, ChineseAMS

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

  • Liu J, He M, Ou K, Wang X, Wang Y, Qi L, Chai Y, Jiang M, Ma F, Luo Y, Yuan P, Zhang P, Xu B, Li Q. Efficacy and safety of apatinib combined with dose-dense paclitaxel and carboplatin in neoadjuvant therapy for locally advanced triple-negative breast cancer: A prospective cohort study with propensity-matched analysis. Int J Cancer. 2024 Jan 1;154(1):133-144. doi: 10.1002/ijc.34717. Epub 2023 Sep 7.

    PMID: 37676110DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

apatinibPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Qiao Li

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Binghe Xu

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu

CONTACT

86-87788826xubinghe@medmall.com

Qiao Li

CONTACT

86-87788120Liqiaopumc@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 8, 2018

Study Start

November 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

November 8, 2018

Record last verified: 2018-11

Locations

CN(1)