Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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The control group received docetaxel + capecitabine regimen;Experimental group received Nimotuzumab combined docetaxel + capecitabine regimen.The main purpose is to evaluate Nimotuzumab Plus Docetaxel and Capecitabine（TX）as First-Line Treatment in Patients With Recurrent/Metastatic triple negative breast cancer would improve objective response rate (ORR ) comparing with Docetaxel and Capecitabine（TX）.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nimotuzumab,docetaxel,capecitabine

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

Group Type EXPERIMENTAL

Nimotuzumab

Intervention Type DRUG

docetaxel

Intervention Type DRUG

capecitabine

Intervention Type DRUG

docetaxel,capecitabine

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

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

capecitabine

Intervention Type DRUG

Interventions

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Nimotuzumab

Intervention Type DRUG

docetaxel

Intervention Type DRUG

capecitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Histological and immunohistochemistry (IHC) confirmed recurrent or metastatic triple-negative breast cancer .
2. Previous chemotherapy should include anthracycline or taxane; No prior chemotherapy after metastasis.
3. Females with age between 18 and 70 years old
4. ECOG performance status 0 or 1.
5. 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;
6. Life expectancy ≥ 12 weeks.；
7. WBC count ≥ 4 × 109 / L, neutrophils ≥ 1.5 × 109 / L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 6.21mmol / L (10 g / dL);
8. 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.
9. Before enrollment, patients have fully recovered from previous treatment-related toxicity;
10. Subjects with fertility must accept effective contraceptive measures;
11. Signed informed consent

Exclusion Criteria

1. Previously treatment regimen including anti EGFR monoclonal antibody;
2. Receiving other anti-cancer medicine treatment during the study
3. Participate in other clinical trials within 4 weeks in this group;
4. Accepted taxane treatment in 1 year;
5. Presence of neurological symptoms due to brain metastasis, patients receiving steroidal anti-edema drugs therapy;
6. Patients having a history of clinically significant symptomatic angina, arrhythmia or congestive heart failure without control;
7. Diagnosed with severe interstitial pneumonitis or pulmonary fibrosis by chest CT;
8. Pleural effusion, ascites require to be drained;
9. 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;
10. 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);
11. Uncontrolled seizures or loss of insight due to mental disorders;
12. Pregnant or lactating women；
13. Researchers think improper for this trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Binghe Xu

Director of Medical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Binghe Xu

Role: PRINCIPAL_INVESTIGATOR

Cancer Insititute and Hospital, CAMS

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING