NCT01939054

Brief Summary

Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. This is a randomized, controlled, open-Label, multicenter, phase Ⅱ clinical trial of nimotuzumab plus Docetaxel and Capecitabine（TX）versus Docetaxel and Capecitabine（TX）as first-line treatment in patients with recurrent/metastatic triple negative breast cancer.

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
90

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

9 active sites

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

First Submitted

Initial submission to the registry

August 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

August 28, 2013

Last Update Submit

June 3, 2015

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • ORR

    Evaluation ORR every six weeks,with RECIST 1.1.

    every six weeks, up to 1 year

Secondary Outcomes (3)

  • PFS

    every six weeks, up to 1 year

  • Number and ratio of AEs

    up to 1 year

  • Relationship of tissue/serum EGFR between efficacy and prognosis

    1 year

Study Arms (2)

Nimotuzumab,docetaxel,capecitabine

EXPERIMENTAL

Nimotuzumab 400mg/w,IV,once a week and Docetaxel 75 mg/m2,IV,D1, every 21 days a cycle and Capecitabine 1000mg/m2, orally, twice daily, D1-D14

Drug: NimotuzumabDrug: docetaxelDrug: capecitabine

docetaxel,capecitabine

ACTIVE COMPARATOR

Docetaxel 75 mg/m2,IV,D1, every 21 days a cycle and Capecitabine 1000mg/m2, orally, twice daily, D1-D14

Drug: docetaxelDrug: capecitabine

Interventions

NimotuzumabDRUG
Nimotuzumab,docetaxel,capecitabine
docetaxelDRUG
Nimotuzumab,docetaxel,capecitabinedocetaxel,capecitabine
capecitabineDRUG
Nimotuzumab,docetaxel,capecitabinedocetaxel,capecitabine

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological and immunohistochemistry (IHC) confirmed recurrent or metastatic triple-negative breast cancer .
  • Previous chemotherapy should include anthracycline or taxane; No prior chemotherapy after metastasis.
  • Females with age between 18 and 70 years old
  • ECOG performance status 0 or 1.
  • At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST) by magnetic resonance imaging, or computed tomography; The target lesions is Unresectable; The target lesions did not receive radiotherapy or relapse within the radiation field;
  • Life expectancy ≥ 12 weeks.；
  • WBC count ≥ 4 × 109 / L, neutrophils ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 6.21mmol / L (10 g / dL);
  • Total bilirubin (TBL)≤ 1.5 x ULN (upper limit of normal reference values); AST and ALT ≤ 2.5 x ULN or ≤ 5 ULN (Liver metastasis);Serum creatinine ≤ 1.5 x ULN.
  • Before enrollment, patients have fully recovered from previous treatment-related toxicity;
  • Subjects with fertility must accept effective contraceptive measures;
  • Signed informed consent

You may not qualify if:

  • Previously treatment regimen including anti EGFR monoclonal antibody;
  • Receiving other anti-cancer medicine treatment during the study
  • Participate in other clinical trials within 4 weeks in this group;
  • Accepted taxane treatment in 1 year;
  • Presence of neurological symptoms due to brain metastasis, patients receiving steroidal anti-edema drugs therapy;
  • Patients having a history of clinically significant symptomatic angina, arrhythmia or congestive heart failure without control;
  • Diagnosed with severe interstitial pneumonitis or pulmonary fibrosis by chest CT;
  • Pleural effusion, ascites require to be drained;
  • Adverse drug addiction and drug abuse, long-term alcoholics, as well as AIDS patients; patients with severe or uncontrolled complications, such as infection requiring systemic therapy, fever (≥ 38 ℃), diabetes or hypertension can not be controlled by medicine, other complications may interfere with drug therapy;
  • Patients with a history of drug allergy (≥ CTCAE 2 level) such as shock or allergic symptoms, especially have allergic reactions to similar drugs in the past, have severe allergies reactions to drugs containing polysorbate eighty (Tween 80);
  • Uncontrolled seizures or loss of insight due to mental disorders;
  • Pregnant or lactating women；
  • Researchers think improper for this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing cancer hospital

Beijing, Beijing Municipality, 100142, China

NOT YET RECRUITING

The General Hospital of the People's Liberation Army (PLAGH)

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

NOT YET RECRUITING

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Xijing Hospital

Xi’an, Shanxi, 710032, China

NOT YET RECRUITING

The First Affiliated Hospital of College of Medicine, Zhejiang University (First Hospital of Zhejiang Province)

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

nimotuzumabDocetaxelCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Binghe Xu

    Cancer Insititute and Hospital, CAMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Binghe Xu

CONTACT

86-10-88788826xubinghe@medmail.com.cn

Peng Yuan

CONTACT

86-10-8778 8114yuanpeng01@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Medical Oncology

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 11, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

CN(9)