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

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

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: docetaxel; Drug: capecitabine; Drug: Nimotuzumab

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）.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Binghe Xu; Phone Number: 86-10-88788826; Email: xubinghe@medmail.com.cn
• Study Contact Backup: Name: Peng Yuan; Phone Number: 86-10-8778 8114; Email: yuanpeng01@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Not yet recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Contact: Binghe Xu, M.D.; Phone Number: 86-10-88788826; Email: xubinghe@medmail.com.cn
    • Beijing, Beijing, China
      • Not yet recruiting
      • The General Hospital of the People's Liberation Army (PLAGH)
      • Contact: junlan yang
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • Not yet recruiting
      • Liaoning Cancer Hospital and Institute
  • Shanghai
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Fudan University Shanghai Cancer Center
  • Shanxi
    • Xi-an, Shanxi, China, 710032
      • Not yet recruiting
      • Xijing Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • The First Affiliated Hospital of College of Medicine, Zhejiang University (First Hospital of Zhejiang Province)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: docetaxel; Drug: capecitabine; Drug: Nimotuzumab
Active Comparator: docetaxel,capecitabine; Docetaxel 75 mg/m2,IV,D1, every 21 days a cycle and Capecitabine 1000mg/m2, orally, twice daily, D1-D14	Drug: docetaxel; Drug: capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Evaluation ORR every six weeks,with RECIST 1.1.	every six weeks, up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS		every six weeks, up to 1 year
Number and ratio of AEs	Observe and record AEs when AEs occurred	up to 1 year
Relationship of tissue/serum EGFR between efficacy and prognosis	every 6 weeks	1 year

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Biotech Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Binghe Xu, Cancer Insititute and Hospital, CAMS

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (Estimate): September 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 4, 2015
• Last Update Submitted That Met QC Criteria: June 3, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Capecitabine; Nimotuzumab
• Other Study ID Numbers: BT-BC-001