Breast Cancer MetastaticPhase 2NCT03086785
Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
A Phase 2 study testing Apatinib in people with Breast Cancer Metastatic, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2016to May 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old (female)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Pathologically diagnosed with her-2 negative, ER/PR negative, ER/PR positive after the failure of endocrine treatment, and had not more than three chemotherapy regimens (must include anthracycline-based and yew class), and the final failure of chemotherapy regimens in patients with advanced breast cancer; Note: treatment failure include (1) during or after the completion of six months or less disease progress of neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or less
- Patients with at least one measurable lesions of the advanced breast cancer， measurable lesions has not received radiotherapy or other treatment, unless progress after treatment (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO);
- Major organ function has to meet the following certeria:
- For results of blood routine test (without blood transfusion within 14 days)
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- HB≥100g/L;
- ANC≥1.5×109/L;
- PLT≥75×109/L;
- For results of blood biochemical test：
- TBIL<1.5ULN；
- ALTand AST<2.5ULN, but5<ULN if the transferanse elevation is due to liver metastases；
- Serum creatinine ≤1.25ULN , or calculated creatinine clearance>45 ml/min(per the Cockcroft-Gault formula); 6.Participants were willing to join in this study, and written informed consent.
Who cannot join
- The patients with the failure of capecitabine treatment；
- The patients with chest wall invasion, or chest wall large canker has a tendency to transfer；
- Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease, unable to control arrhythmia (including QTc lengthened women > 470 ms) and classⅢ-Ⅳcardiac insufficiency; or Left ventricular ejection fraction (LVEF) < 50%；
- A variety of factors influencing oral drugs (such as unable to swallow, after resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.)；
- Has a history of bleeding, the clinical significance of bleeding symptoms, patients with definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period （+ +）and above of defecate occult blood, vasculitis, etc；
- Received a major surgery within 4 weeks or severe traumatic injury, fractures, or has a poor healing wound；
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- Allergic to apatinib and supplementary material；
- Patients with active brain metastases;
- Patients with pregnant or planning a pregnancy;
- The researchers think inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050019
Cuizhi Geng, archiater, 0311-66696310, gengcuizhi@hotmail.com
About this study
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.
- Conditions
- Breast Cancer Metastatic
- Being tested
- Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
apatinib 500mg qd po or combined capecitabine 1000mg/m2 bid d1-14 q3w
| Study group | Role | What they receive |
|---|---|---|
| apatinib | Experimental | apatinib 500mg qd po or combined Capecitabine 1000mg/m2 bid d1-d14 q3w Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Baseline to measured date of progression or death from any cause
Measured: evaluated in 24 months since the treatment began
Secondary outcomes (4)
Overall survival
Baseline to measured date of death from any cause
Measured: the first day of treatment to death or last survival confirm date,up to 24 months
Disease control rate
Baseline to measured progressive disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 months
Objective response rate
Baseline to measured stable disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 24 months
Side effects
throughout study
Measured: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start24 Nov 2016
- Primary completionNov 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- cuizhi Geng, archiat, Principal investigator, Hebei Medical University Fourth Hospitalzefei Jiang, archiat, Principal investigator, The 307th Hospital of Chinese Peoples' Liberation Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086785
- Sponsor's protocol ID
- HB-B001
- Status last verified
- Jan 2018
- First submitted
- 16 Mar 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Observational Study of Apatinib Single or Combined Capecitabine for Treatment of Patients With Metastatic Her-2 Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03086785
- Acronym / sponsor ID
- HB-B001
- Conditions
- Breast Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 22 Mar 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.
The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apatinib | Experimental | Drug: Apatinibapatinib 500mg qd po or combined Capecitabine 1000mg/m2 bid d1-d14 q3w |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 to 70 years old (female)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Pathologically diagnosed with her-2 negative, ER/PR negative, ER/PR positive after the failure of endocrine treatment, and had not more than three chemotherapy regimens (must include anthracycline-based and yew class), and the final failure of chemotherapy regimens in patients with advanced breast cancer; Note: treatment failure include (1) during or after the completion of six months or less disease progress of neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or less
- Patients with at least one measurable lesions of the advanced breast cancer， measurable lesions has not received radiotherapy or other treatment, unless progress after treatment (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO);
- Major organ function has to meet the following certeria:
Key exclusion criteria (10 listed)
- The patients with the failure of capecitabine treatment；
- The patients with chest wall invasion, or chest wall large canker has a tendency to transfer；
- Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), with classⅡand above coronary heart disease, unable to control arrhythmia (including QTc lengthened women > 470 ms) and classⅢ-Ⅳcardiac insufficiency; or Left ventricular ejection fraction (LVEF) < 50%；
- A variety of factors influencing oral drugs (such as unable to swallow, after resection of the gastrointestinal, chronic diarrhea and intestinal obstruction, etc.)；
- Has a history of bleeding, the clinical significance of bleeding symptoms, patients with definite bleeding tendency, such as gastrointestinal bleeding, bleeding ulcers, baseline period （+ +）and above of defecate occult blood, vasculitis, etc；
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 |
|---|---|---|
| Apatinibapatinib 500mg qd po or combined capecitabine 1000mg/m2 bid d1-14 q3w | Drug | apatinib |
Primary outcome
Progression free survival
Time frame: evaluated in 24 months since the treatment began
Baseline to measured date of progression or death from any cause
4 secondary outcomes
Overall survival
Time frame: the first day of treatment to death or last survival confirm date,up to 24 months
Disease control rate
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
Objective response rate
Time frame: tumor assessment every 6 weeks since the treatment began，up to 24 months
Side effects
Time frame: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
cuizhi Geng, archiat principal investigator
Hebei Medical University Fourth Hospital
zefei Jiang, archiat principal investigator
The 307th Hospital of Chinese Peoples' Liberation Army
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 Apatinib in people with Breast Cancer Metastatic, 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 13 inclusion and 10 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 17 Jan 2018. 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 cuizhi Geng, archiat (0311-66696310, gengcuizhi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: evaluated in 24 months since the treatment began). 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 17 Jan 2018.