Stage III Breast CancerPhase 2/3TENDENCYNCT01907529
A Trail of Neoadjuvant Endostar in Combination With Chemotherapy in Breast Cancer
A Phase 2/3 study testing docetaxel, epirubicin and cyclophosphamide and docetaxel, epirubicin and cyclophosphamide plus endostar in people with Stage III Breast Cancer, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Stage III Breast Cancer
- What is being tested?
- docetaxel, epirubicin and cyclophosphamide and docetaxel, epirubicin and cyclophosphamide plus endostar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2019to Dec 2021
- Phase
- Phase 2/3
- 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
- Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
- Age 18-70
- No evidence of distant metastasis
- No previous therapy
- Normal hematologic function
- No abnormality of renal or liver function
- Written informed consent
Who cannot join
- With allergic constitution or possible allergic reflection to drugs to be used in this study
- Any concurrent uncontrolled medical or psychiatric disorder
- History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
- Being pregnant or nursing
Trial locations and contacts
1 site in 1 country.
China1 site
Fourth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, China
Shijiazhuang, Hebei, 050011
About this study
Official title: A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)
The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.
- Conditions
- Stage III Breast Cancer
- Being tested
- docetaxel, epirubicin and cyclophosphamide, docetaxel, epirubicin and cyclophosphamide plus endostar
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel, epirubicin and cyclophosphamideDrug
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; totally 4 cycles
docetaxel, epirubicin and cyclophosphamide plus endostarDrug
docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostar 7.5mg/m2, IV (in the vein) from day 1 to day 14, totally 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Chemo plus Endostar | Experimental | Docetaxel, epirubicin and cyclophosphamide plus endostar Receives: Drug: docetaxel, epirubicin and cyclophosphamide plus endostar |
| Chemo only | Active comparator | docetaxel, epirubicin and cyclophosphamide Receives: Drug: docetaxel, epirubicin and cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical/pathological response
The clincial response will be evaluated according to RECIST criteria.
Measured: 48 months
Secondary outcomes (1)
PFS
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startAug 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Breast CancerStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunjiang Liu, Hebei Medical University Fourth Hospital
- Investigators
- YUNJIANG LIU, M.D.& PhD., Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907529
- Sponsor's protocol ID
- HBMUFH-101
- Acronym
- TENDENCY
- Status last verified
- Aug 2019
- First submitted
- 22 Jul 2013
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trail of Neoadjuvant Endostar in Combination With Docetaxel, Epirubicin and Cyclophosphamide in Patients With Stage III Breast Cancer (TENDENCY)
- ClinicalTrials.gov ID
- NCT01907529
- Acronym / sponsor ID
- TENDENCY / HBMUFH-101
- Conditions
- Stage III Breast Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Jul 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.
The trial was designed to study the efficacy and safety of neoadjuvant docetaxel, epirubicin in combination with cyclophosphamide(DEC) plus human recombinant endostatin (endostar) for breast cancer patients. The hypothesis of this protocol is that the combined an active angiogenesis agent to chemotherapy could enhance the pathological responce rate and further benefit breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemo plus Endostar | Experimental | Drug: docetaxel, epirubicin and cyclophosphamide plus endostarDocetaxel, epirubicin and cyclophosphamide plus endostar |
| Chemo only | Active comparator | Drug: docetaxel, epirubicin and cyclophosphamidedocetaxel, epirubicin and cyclophosphamide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed invasive breast cancer (core needle biopsy for breast cancer diagnosis and fine needle aspiration for lymph node metastasis diagnosis)
- Age 18-70
- No evidence of distant metastasis
- No previous therapy
- Normal hematologic function
Key exclusion criteria (4 listed)
- With allergic constitution or possible allergic reflection to drugs to be used in this study
- Any concurrent uncontrolled medical or psychiatric disorder
- History of severe heart diseases, including congestive heart failure, unstable angina, uncontrolled arrhythmia, myocardial infarction, uncontrolled high blood pressure, or heart valve disease
- Being pregnant or nursing
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 |
|---|---|---|
| docetaxel, epirubicin and cyclophosphamidedocetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; totally 4 cycles | Drug | Chemo only |
| docetaxel, epirubicin and cyclophosphamide plus endostardocetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostar 7.5mg/m2, IV (in the vein) from day 1 to day 14, totally 4 cycles | Drug | Chemo plus Endostar |
Primary outcome
Clinical/pathological response
Time frame: 48 months
The clincial response will be evaluated according to RECIST criteria.
1 secondary outcome
PFS
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
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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.
YUNJIANG LIU, M.D.& PhD. principal investigator
Hebei Medical University Fourth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing docetaxel, epirubicin and cyclophosphamide and docetaxel, epirubicin and cyclophosphamide plus endostar in people with Stage III Breast Cancer, run by Hebei Medical University Fourth 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 7 inclusion and 4 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 9 Aug 2019. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical/pathological response (time frame: 48 months). 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 9 Aug 2019.