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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01939054
• Other study ID #: BT-BC-001
• Status: Recruiting
• Phase: Phase 2
• First received: August 28, 2013
• Last updated: June 3, 2015
• Start date: September 2013
• Est. completion date: September 2016

Study information

• Verified date: June 2015
• Source: Chinese Academy of Medical Sciences
• Contact: Binghe Xu
• Phone: 86-10-88788826
• Email: xubinghe[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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）.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Nimotuzumab

• docetaxel

• capecitabine

Locations

Country	Name	City	State
China	Beijing cancer hospital	Beijing	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	The General Hospital of the People's Liberation Army (PLAGH)	Beijing	Beijing
China	The First Affiliated Hospital of College of Medicine, Zhejiang University (First Hospital of Zhejiang Province)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	FuDan University Shanghai Cancer Center	Shanghai	Shanghai
China	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
China	Xijing Hospital	Xi-an	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Evaluation ORR every six weeks,with RECIST 1.1.	every six weeks, up to 1 year	No
Secondary	PFS		every six weeks, up to 1 year	No
Secondary	Number and ratio of AEs	Observe and record AEs when AEs occurred	up to 1 year	No
Secondary	Relationship of tissue/serum EGFR between efficacy and prognosis	every 6 weeks	1 year	No