Breast CancerPhase 2NCT03147963
Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer
A Phase 2 study testing Docetaxel in people with Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2015to 30 Dec 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- The age is Above 18 years of age, <70 years old
- The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative
- Clinical stage was metastatic breast cancer or locally advanced breast cancer.
- Must have at least one measurable lesion, according to RECISTv1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS)=0~2
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- Docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months.
- The basic function of normal bone marrow
- Functions of liver and kidney is normal
- Expectation of life is more than 3 months
- Agreed to take contraceptive measures during treatment
Who cannot join
- The patient had a history of allergy to taxanes or their components.
- Recent progress of taxanes in 6 months.
- In the elution period of other chemotherapy regimens.
- Severe coagulopathy.
- HER2 positive breast cancer
- Previous toxicity was not recovered to 0-1 degrees
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- Central nervous system metastasis had not Controlled yet
- Pregnancy or lactation
- There are uncontrolled infection, myocardial infarction, thrombosis, etc.
- There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
- HIV infection
- Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
- Researchers believe that is not suitable for the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Xiaojia WANG, MD,PhD, +86 13906500190, wxiaojia0803@163.com
Ping HUANG, MD, +86 13685766632, zlyyhp@163.com
About this study
Official title: A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-weeks Regimen
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen
Read the detailed description
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2
- Conditions
- Breast Cancer
- Being tested
- Docetaxel
- Keywords
- therapy, breast cancer, docetaxel, metastasis
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel will be given until progression or patient intolerance
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel 2-Weeks regimen group | Experimental | Docetaxel injection 50mg/m2,iv,d1,every 2 weeks Receives: Drug: Docetaxel |
| Docetaxel 3-Weeks regimen group | Active comparator | Docetaxel injection 75mg/m2,iv,d1,every 3 weeks Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
Measured: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Secondary outcomes (4)
Overall survival(OS)
The time elapsed between enrolling and death from any cause
Measured: From date of enrolling until the date of death from any cause, assessed up to 5 years
Clinical benefit rate(CBR)
The response is CR+PR+SD ≥ 24 weeks
Measured: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Quality of life（QOL）
Score change from enrolling to progression disease or death according EORTC QLQ-C30.The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
Measured: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
Number of participants with Grade 3/4 adverse events
Number of participants with Grade 3/4 adverse events of the two groups was assessed in accordance with the common terminology criteria (NCI CTC AE) version 4.0.
Measured: From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start20 Dec 2015
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Model description
- patients was divided 1:1 into docetaxel 2-weeks regimen group and docetaxel 3-weeks regimen group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Ping, Zhejiang Cancer Hospital
- Investigators
- Xiaojia WANG, MD,PHD, Principal investigator, Zhejiang Cance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147963
- Sponsor's protocol ID
- ZCHBC0011
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nabholtz JM, Falkson C, Campos D, Szanto J, Martin M, Chan S, Pienkowski T, Zaluski J, Pinter T, Krzakowski M, Vorobiof D, Leonard R, Kennedy I, Azli N, Murawsky M, Riva A, Pouillart P; TAX 306 Study Group. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol. 2003 Mar 15;21(6):968-75. doi: 10.1200/JCO.2003.04.040.
PubMed 12637459
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-weeks Regimen
- ClinicalTrials.gov ID
- NCT03147963
- Acronym / sponsor ID
- ZCHBC0011
- Conditions
- Breast Cancer
- Keywords
- therapy, breast cancer, docetaxel, metastasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 20 Dec 2015 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 10 May 2017 (actual)
- 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.
A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen
Detailed description
Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients was divided 1:1 into docetaxel 2-weeks regimen group and docetaxel 3-weeks regimen group
| Arm | Type | Receives |
|---|---|---|
| Docetaxel 2-Weeks regimen group | Experimental | Drug: DocetaxelDocetaxel injection 50mg/m2,iv,d1,every 2 weeks |
| Docetaxel 3-Weeks regimen group | Active comparator | Drug: DocetaxelDocetaxel injection 75mg/m2,iv,d1,every 3 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent
- The age is Above 18 years of age, <70 years old
- The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative
- Clinical stage was metastatic breast cancer or locally advanced breast cancer.
- Must have at least one measurable lesion, according to RECISTv1.1.
Key exclusion criteria (13 listed)
- The patient had a history of allergy to taxanes or their components.
- Recent progress of taxanes in 6 months.
- In the elution period of other chemotherapy regimens.
- Severe coagulopathy.
- HER2 positive breast cancer
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 |
|---|---|---|
| DocetaxelDocetaxel will be given until progression or patient intolerance | Drug | Docetaxel 2-Weeks regimen group, Docetaxel 3-Weeks regimen group |
Primary outcome
Progression-free survival(PFS)
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause
4 secondary outcomes
Overall survival(OS)
Time frame: From date of enrolling until the date of death from any cause, assessed up to 5 years
Clinical benefit rate(CBR)
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years
Quality of life（QOL）
Time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years
Number of participants with Grade 3/4 adverse events
Time frame: From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Background: PubMed 12637459Nabholtz JM, Falkson C, Campos D, Szanto J, Martin M, Chan S, Pienkowski T, Zaluski J, Pinter T, Krzakowski M, Vorobiof D, Leonard R, Kennedy I, Azli N, Murawsky M, Riva A, Pouillart P; TAX 306 Study Group. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol. 2003 Mar 15;21(6):968-75. doi: 10.1200/JCO.2003.04.040.
- Individual participant dataSharing planned: No
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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.
Xiaojia WANG, MD,PHD principal investigator
Zhejiang Cance Hospital
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 Docetaxel in people with Breast Cancer, run by Zhejiang Cancer Hospital 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 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 10 May 2017. 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 Xiaojia WANG, MD,PHD (8613906500190, wxiaojia0803@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03147963, which also lists 1 linked publication.
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 10 May 2017.