Breast CancerBIBCNCT01652560
Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy
An observational study of Breast Cancer and Bevacizumab, run by LiNanlin,Ph.D, Chief Physician,Clinical Professor at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Bevacizumab, Neoadjuvant Chemotherapy
- What is being tested?
- bevacizumab
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jun 2012to Sep 2014
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients of vascular endocrine surgery department in Xijing Hospital
Who may be able to join
- HER2-negative breast cancer patients
- Without surgery
- Plans to neoadjuvant chemotherapy
Who cannot join
- HER2-positive breast cancer patients
- Post-operative patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital ， Fourth Military Medical University
Xi'an, Shaanxi, 710032
Nanlin Li, Ph.D, +86-186-2963-7041, nanlin-74@163.com
Hongyu Xiao, Master, +86-186-2963-7040, louch2008@126.com
About this study
- The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.
- Being tested
- bevacizumab
- Keywords
- bevacizumab, neoadjuvant chemotherapy, HER2-negative breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Also called Avastin
The patients will be treated with Avastin combined neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab combined neoadjuvant chemotherapy | Not described Receives: Drug: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Measured: From enrollment to disease progression
Secondary outcomes (1)
overall response
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Measured: From enrollment to disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014 (estimated)
- Study completionSep 2014 (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
- Observational
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LiNanlin,Ph.D, Chief Physician,Clinical Professor
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor-investigator, LiNanlin,Ph.D, Chief Physician,Clinical Professor, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652560
- Sponsor's protocol ID
- QTDS-01
- Acronym
- BIBC
- Status last verified
- Jul 2012
- First submitted
- 21 Jul 2012
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01652560
- Acronym / sponsor ID
- BIBC / QTDS-01
- Keywords
- bevacizumab, neoadjuvant chemotherapy, HER2-negative breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LiNanlin,Ph.D, Chief Physician,Clinical ProfessorUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 30 Jul 2012 (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 purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab combined neoadjuvant chemotherapy | – | Drug: bevacizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients of vascular endocrine surgery department in Xijing Hospital
Key inclusion criteria (3 listed)
- HER2-negative breast cancer patients
- Without surgery
- Plans to neoadjuvant chemotherapy
Key exclusion criteria (2 listed)
- HER2-positive breast cancer patients
- Post-operative patients
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 |
|---|---|---|
| bevacizumabAlso: AvastinThe patients will be treated with Avastin combined neoadjuvant chemotherapy | Drug | bevacizumab combined neoadjuvant chemotherapy |
Primary outcome
Objective Response Rate
Time frame: From enrollment to disease progression
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
1 secondary outcome
overall response
Time frame: From enrollment to disease progression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Bevacizumab, run by LiNanlin,Ph.D, Chief Physician,Clinical Professor 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 3 inclusion and 2 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 30 Jul 2012. 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.
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 Nanlin Li, Phd (+86-186-2963-7041, nanlin-74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From enrollment to disease progression). 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 30 Jul 2012.