Breast NeoplasmsPhase 2NCT02510781
A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs
A Phase 2 study testing Epirubicin, Docetaxel and Trastuzumab in people with Breast Neoplasms, run by Hospital Affiliated to Military Medical Science, Beijing at 1 site in China.
Trial summary
Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when used the anthracycline instead of… Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Epirubicin, Docetaxel and Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- 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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18≤aged<70
- pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by MRI or axillary lymph node（+）
- Immunohistochemical（IHC） positive for 3+ or FISH（+）
- clear hormone receptor（HR） status
- Eastern cooperative oncology group(ECOG)=0/1
- LVEF≥55%
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- pathologic grading of Miller and Payne
- screening laboratory values with the following parameters：absolute neutrophils acount：≥1500/mm3,total bilirubin:≤2.0×ULM,Aspartate transaminase (AST)/ALT≤2.5×ULM,platelet≥80000/mm3，serum creatinine≤1.5×ULM
- no pregnant or nursing
- signed Informed consent forms
Who cannot join
- prior exposure to any treatments for breast cancer
- inflammatory/Bilateral/IV stage breast cancer
- poor physical condition
- pregnant or nursing
- Cardiac risk（Congestive heart failure、arrhythmia、myocardial infarct、Refractory hypertension（systolic pressure>180mmHg/diastolic pressure>100mmHg））
- any other cancer within 5 years prior to screening with the exception of cervical carcinoma and non melanoma skin cancer
- Allergic to chemotherapy drugs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hospital affiliated to military medical science
Beijing, Beijing Municipality, 100000
tao wang, Ph.D, 8610-66947172, wangtao733073@163.com
zefei jiang, ph.d, 8610-66947171, zfjiang@hotmail.com
About this study
Official title: A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells
Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when used the anthracycline instead of carboplatin. The investigators expect to carry out a large sample size clinical research to optimize the existing therapeutic regimen
- Conditions
- Breast Neoplasms
- Being tested
- Epirubicin, Docetaxel, Trastuzumab, Carboplatin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
Also called pharmorubicin
75mg/m2 d1 evry 21days
DocetaxelDrug
Also called Taxotere
75mg/m2 d1 evry 21days
TrastuzumabDrug
Also called Herceptin
6mg/kg(loading dosage is 8mg/kg)
CarboplatinDrug
Also called Paraplatin
Area Under Curve(AUC)=6 d1 evry 21days
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | docetaxel+carboplatin+trastuzumab Receives: Drug: Docetaxel; Drug: Trastuzumab; Drug: Carboplatin |
| B group | Active comparator | Epirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab Receives: Drug: Epirubicin; Drug: Docetaxel; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response rate
Measured: up to one year
Secondary outcomes (2)
clinical response rate
Measured: up to one year
Number of Adverse Event
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Affiliated to Military Medical Science, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zefei jiang, Ph.D, Principal investigator, Academy MMS,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510781
- Sponsor's protocol ID
- BJ307-Neo02
- Status last verified
- Jul 2015
- First submitted
- 23 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells
- ClinicalTrials.gov ID
- NCT02510781
- Acronym / sponsor ID
- BJ307-Neo02
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital Affiliated to Military Medical Science, BeijingUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Jul 2015 (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.
Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when used the anthracycline instead of carboplatin. The investigators expect to carry out a large sample size clinical research to optimize the existing therapeutic regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: Docetaxel, Drug: Trastuzumab, Drug: Carboplatindocetaxel+carboplatin+trastuzumab |
| B group | Active comparator | Drug: Epirubicin, Drug: Docetaxel, Drug: TrastuzumabEpirubicin+docetaxel+trastuzumab-docetaxel+trastuzumab |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18≤aged<70
- pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by MRI or axillary lymph node（+）
- Immunohistochemical（IHC） positive for 3+ or FISH（+）
- clear hormone receptor（HR） status
- Eastern cooperative oncology group(ECOG)=0/1
Key exclusion criteria (7 listed)
- prior exposure to any treatments for breast cancer
- inflammatory/Bilateral/IV stage breast cancer
- poor physical condition
- pregnant or nursing
- Cardiac risk（Congestive heart failure、arrhythmia、myocardial infarct、Refractory hypertension（systolic pressure>180mmHg/diastolic pressure>100mmHg））
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 |
|---|---|---|
| EpirubicinAlso: pharmorubicin75mg/m2 d1 evry 21days | Drug | B group |
| DocetaxelAlso: Taxotere75mg/m2 d1 evry 21days | Drug | A group, B group |
| TrastuzumabAlso: Herceptin6mg/kg(loading dosage is 8mg/kg) | Drug | A group, B group |
| CarboplatinAlso: ParaplatinArea Under Curve(AUC)=6 d1 evry 21days | Drug | A group |
Primary outcome
pathological complete response rate
Time frame: up to one year
2 secondary outcomes
clinical response rate
Time frame: up to one year
Number of Adverse Event
Time frame: up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 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.
zefei jiang, Ph.D principal investigator
Academy MMS,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epirubicin, Docetaxel and Trastuzumab in people with Breast Neoplasms, run by Hospital Affiliated to Military Medical Science, Beijing at 1 site 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 10 inclusion and 7 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 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 tao wang, Ph.D (8610-66947172, wangtao733073@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response rate (time frame: up to one 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 29 Jul 2015.