Clinical trial NCT01939054: Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients
Official title: A Randomized, Controlled, Open-Label, Multicenter, Phase 2 Study of Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine as First-Line Treatment in Patients With Recurrent/Metastatic Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Biotech Pharmaceutical Co., Ltd.
First posted: 2013-09-11
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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）.

Eligibility criteria: 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

Primary outcomes:
measure: ORR
timeFrame: every six weeks, up to 1 year
Secondary outcomes:
measure: PFS
timeFrame: every six weeks, up to 1 year
measure: Number and ratio of AEs
timeFrame: up to 1 year
measure: Relationship of tissue/serum EGFR between efficacy and prognosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing cancer hospital
state: Beijing
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army (PLAGH)
state: Beijing
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Shenyang
country: China
facility: Liaoning Cancer Hospital and Institute
state: Liaoning
city: Shanghai
country: China
facility: FuDan University Shanghai Cancer Center
state: Shanghai
city: Xi-an
country: China
facility: Xijing Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University (First Hospital of Zhejiang Province)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Cancer Insititute and Hospital, CAMS
name: Binghe Xu
role: PRINCIPAL_INVESTIGATOR
References: