Breast CancerPhase 2NCT01939054
Nimotuzumab Plus Docetaxel and Capecitabine Versus Docetaxel and Capecitabine in the Treatment of Breast Cancer Patients
A Phase 2 study testing Nimotuzumab, docetaxel and capecitabine in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 9 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nimotuzumab, docetaxel and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 9 sitesChina
- Study dates
- Sep 2013to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.；
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- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Binghe Xu, M.D., 86-10-88788826, xubinghe@medmail.com.cn
Peng Yuan, M.D.
- Not yet recruiting
Beijing cancer hospital
Beijing, Beijing Municipality, 100142
huiping Li
- Not yet recruiting
The General Hospital of the People's Liberation Army (PLAGH)
Beijing, Beijing Municipality
junlan yang
- Not yet recruiting
The First Affiliated Hospital of College of Medicine, Zhejiang University (First Hospital of Zhejiang Province)
Hangzhou, Zhejiang
peifen fu
- Not yet recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
xiaojia wang
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
li cai
- Not yet recruiting
FuDan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
xichun Hu
- Not yet recruiting
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning
tao sun
- Not yet recruiting
Xijing Hospital
Xi’an, Shanxi, 710032
rui ling
About this study
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
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.
Read the 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）.
- Conditions
- Breast Cancer
- Being tested
- Nimotuzumab, docetaxel, capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NimotuzumabDrug
docetaxelDrug
capecitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Nimotuzumab; Drug: docetaxel; Drug: 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 Receives: Drug: docetaxel; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Evaluation ORR every six weeks,with RECIST 1.1.
Measured: every six weeks, up to 1 year
Secondary outcomes (3)
PFS
Measured: every six weeks, up to 1 year
Number and ratio of AEs
Observe and record AEs when AEs occurred
Measured: up to 1 year
Relationship of tissue/serum EGFR between efficacy and prognosis
every 6 weeks
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2015 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Biotech Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Binghe Xu, Chinese Academy of Medical Sciences
- Investigators
- Binghe Xu, Principal investigator, Cancer Insititute and Hospital, CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939054
- Sponsor's protocol ID
- BT-BC-001
- Status last verified
- Jun 2015
- First submitted
- 28 Aug 2013
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01939054
- Acronym / sponsor ID
- BT-BC-001
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Biotech Pharmaceutical Co., Ltd.
- Study start
- Sep 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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）.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimotuzumab,docetaxel,capecitabine | Experimental | Drug: Nimotuzumab, Drug: docetaxel, Drug: capecitabineNimotuzumab 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 |
| docetaxel,capecitabine | Active comparator | Drug: docetaxel, Drug: capecitabineDocetaxel 75 mg/m2,IV,D1, every 21 days a cycle and Capecitabine 1000mg/m2, orally, twice daily, D1-D14 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab,docetaxel,capecitabine |
| docetaxel | Drug | Nimotuzumab,docetaxel,capecitabine, docetaxel,capecitabine |
| capecitabine | Drug | Nimotuzumab,docetaxel,capecitabine, docetaxel,capecitabine |
Primary outcome
ORR
Time frame: every six weeks, up to 1 year
Evaluation ORR every six weeks,with RECIST 1.1.
3 secondary outcomes
PFS
Time frame: every six weeks, up to 1 year
Number and ratio of AEs
Time frame: up to 1 year
Relationship of tissue/serum EGFR between efficacy and prognosis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binghe Xu principal investigator
Cancer Insititute and Hospital, CAMS
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nimotuzumab, docetaxel and capecitabine in people with Breast Cancer, run by Chinese Academy of Medical Sciences at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghe Xu (86-10-88788826, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: every six weeks, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.