Breast NeoplasmsPhase 2NCT01281696
Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis
A Phase 2 study testing Bevacizumab, etoposide, cisplatin and Intrathecal methotrexate in people with Breast Neoplasms and Leptomeningeal Metastasis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and cisplatin in treating breast cancer patients with central nervous system metastasis (including brain parenchymal and leptomeningeal metastasis). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms, Leptomeningeal Metastasis, Brain Metastases
- What is being tested?
- Bevacizumab, etoposide, cisplatin and Intrathecal methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Oct 2013
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A histological confirmed invasive breast cancer
- Patient with at least one measurable brain metastatic tumor (≧10mm on T1-weighted gadolinium enhanced MRI or contrast-enhanced CT) or leptomeningeal metastasis with positive CSF cytology study.
- Patient whose brain parenchymal metastatic tumors either progress after WBRT, develop new lesions after WBRT, or CNS metastatic tumor do not response to WBRT according to image study 3 months after treatment. Patients with leptomeningeal metastasis does not necessarily need whole brain radiotherapy before enrollment.
- Patients with Her2/neu overexpression or amplification will be allowed but will be informed about other available treatment options such as lapatinib plus capecitabine.
- Patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:
- Absolute neutrophil count ≧1,000/mcL
Show all 19Show fewer
- Platelets ≧75,000/mcL
- Total bilirubin ≦ 1.5 X upper normal limit
- AST(SGOT)/ALT(SGPT) ≦ 2.5 X upper normal limit; for patients with liver metastases AST(SGOT)/ALT(SGPT) ≦ 5 X is allowed
- Serum creatinine ≦ upper normal limit or creatinine clearance ≧50ml/min
- Hemoglobin≧8.0 gm/dL
- PTT ≦ upper normal limit; INR ≦ 1.5
- Proteinuria ≤ 1+, if > 1+, urine protein must be ≦ 1 g/24 hours
- Patient age 18 to 75 years
- Patient's life expectancy is more than 2 months
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0, 1, 2 or 3
- All women of childbearing potential must have a negative pregnancy test obtained within 72 hours before starting therapy
- Patients with reproductive potential must use effective contraception (hormone or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 2 months after the completion of therapy
- Patients (or a surrogate) must be able to comply with study procedures and sign informed consent
Who cannot join
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy
- Patients whose CNS metastasis progressed or developed during prior cisplatin treatment
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- History of thrombotic disorders
- Active gastrointestinal bleeding
- Patients with a history of self-reported intra-cranial hemorrhage
Show all 20Show fewer
- Patients with clinical signs or symptoms of gastrointestinal obstruction and who require parenteral hydration and/or nutrition because of obstruction
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of first dose of bevacizumab
- Clinically significant peripheral artery disease
- Arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction
- History of gross hemoptysis (i.e. ≥ 1 teaspoon of bright red blood)
- Other malignancy within 5 years except cured basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Psychiatric illness or social situation that would preclude study compliance
- Serious non-healing wound, ulcer, or bone fracture
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment
- Prior minor surgery or needle biopsies within 7 days
- Concurrent chronic daily aspirin (> 325 mg/day), dipyridamole, ticlopidine, clopidogrel, cilostazol, non-steroidal anti-inflammatory agents known to inhibit platelet function
- Concurrent therapeutic anticoagulation, but prophylactic anti-coagulation of venous access devices is allowed
- History of allergic reaction to compounds of similar chemical composition to the study drugs
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Oncology, National Taiwan University Hospital
Taipei, Taipei City, 100
About this study
Official title: A Phase II Study of Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis
The main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and cisplatin in treating breast cancer patients with central nervous system metastasis (including brain parenchymal and leptomeningeal metastasis).
Read the detailed description
Brain metastases are increasingly important causes of morbidity and mortality in breast cancer patients. Whole brain radiotherapy (WBRT) and surgery remains the standard treatment for brain metastases. However, the median overall survival after brain and leptomeningeal metastasis were only 8.5 months and 16 weeks respectively There is lack of standard treatment for brain metastasis progression post WBRT. Chemotherapy was considered mostly poor for treatment response because of the blood brain barrier. However, this has been questioned because tumor can disrupt the normal function of blood brain barrier. For example, etoposide and cisplatin had been used for treatment for breast cancer patients with brain metastasis. The overall response rate of central nervous system (CNS) was 39 %, disease control rate was 60%, although the median overall survival was 31 weeks only. The role of targeted therapies is actively being assessed. Recently, a phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer showed that CNS objective response rates were 6% to lapatinib monotherapy and 20% to lapatinib plus capecitabine. Although the result is promising, the treatment population is limited in the HER2 overexpression breast cancer.
Bevacizumab, an anti-angiogenic agent, has been approved to combine with several chemotherapy agents in breast, lung and colon cancer. It was once considered contraindicated in patients with brain metastases due to the possibility of intracranial bleeding. However, two studies involving the use of bevacizumab for treating brain metastatic tumors of non-squamous or peripherally located squamous lung cancer showed no report of brain hemorrhage. In addition, bevacizumab has been approved to treat primary brain aggressive tumors recently.
In the institution, the investigators treated three breast cancer patients with multiple brain metastases using bevacizumab plus etoposide and cisplatin (B-EP). All of them have been treated for at least two lines of chemotherapy before brain metastases occurred. All of them received WBRT for brain metastases and one of them also received craniotomy with brain tumor resection plus local stereotactic radiosurgery. The follow up magnetic resonance imaging (MRI) had revealed recurrent metastatic brain tumors in one patients, and recurrence of leptomeningeal metastasis in another two patients. One patient who has multiple brain parenchyma metastases showed objective response on MRI after two cycle of B-EP treatment, and remained progression free for more than 5 months. The other two patients with leptomeningeal metastasis had intrathecal and intraventricular (via Ommaya reservoir) methotrexate treatment for more than eight doses. They were near stupor before B-EP treatment. Both had best clinical response of full recovery of consciousness and absence of cancer cells in cerebrospinal fluid. One survived eight months after the diagnosis leptomeningeal metastasis, and the other two were still alive six months after the diagnosis of leptomeningeal metastasis .
Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) has been used in various studies for evaluation of anti-angiogenic condition. In breast cancer, DCE-MRI has been used as an early predictive marker for response. Glioblastoma patients have also been evaluated with DCE-MRI to determine reduction of vessel permeability after bevacizumab treatment.
Proton magnetic resonance spectroscopy (1H-MRS) has been used to different benign brain tumors from malignant ones. The utilization of 1H-MRS, especially in human brain tumors, coupled to both routine MRI and functional MRI techniques provides greater information concerning tumor grading and extension and characterization of the normal surrounding tissue than what is possible with any other imaging technique alone. To analyze proton spectroscopy before and after bevacizumab may give us further information about the mechanism of B-EP on CNS metastasis.
Therefore, the investigators propose to conduct a phase II clinical trial to test the efficacy of B-EP regimen in breast cancer patients with CNS metastasis along with brain DCE-MRI to demonstrate the antiangiogenesis efficacy.
- Being tested
- Bevacizumab, etoposide, cisplatin, Intrathecal methotrexate
- Keywords
- Breast cancer, CNS metastasis, Brain metastasis, Leptomeningeal metastasis, Bevacizumab, Etoposide, Cisplatin
- Medical subject headings
- Breast Neoplasms, Meningeal Carcinomatosis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab, etoposide, cisplatinDrug
Also called Bevacizumab (Avastin)
Bevacizumab (15mg/kg) on D1, etoposide (70mg/m2) on D2-D4, cisplatin (70mg/m2) on D2; 21 days a cycle, for a maximum of 6 cycles
Intrathecal methotrexateDrug
Also called Methotrexate
Additional intrathecal methotrexate only given in patients with leptomeningeal metastasis
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab, etoposide, cisplatin (BEEP) | Experimental | Not described Receives: Drug: Bevacizumab, etoposide, cisplatin; Drug: Intrathecal methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of central nervous system (CNS) metastasis
The response criteria for brain parenchymal metastasis is measured according to the volumetric response criteria with modification. CNS lesion(s) which have a ≧ 50% volumetric reduction of in the absence of progressive neurologic signs and symptoms will be considered as responsive.
The response criteria for leptomeningeal metastasis is defined as disappearance of carcinoma cells of three consecutive cytology examination of cerebrospinal fluid (CSF) after chemotherapy. For patients with both brain and leptomeningeal metastases, both criteria need to be met to be considered as responsive.
Measured: 1 year
Secondary outcomes (9)
Number of participants with adverse events
To observe the toxicity profile of B-EP according to CTCAE 3.0
Measured: Baseline to until one month after last course of chemotherapy protocol treatment
To evaluate the response rate of breast cancer patients with brain parenchymal metastasis after receiving B-EP
To use volumetric measurement by subtraction image of CT the tumor before and after contrast enhancement; assessed every 9 weeks until best response measured
Measured: 1 year
To evaluate the response rate of breast cancer patients with leptomeningeal carcinomatosis after receiving B-EP
A response is defined as the CSF cytology examination turns from positive to negative. A confirmed response is defined as CSF cytology examination remains negative for two or three consecutive tests
Measured: 1 year
To evaluate the response rate of extra-CNS lesions according to RECIST
To evaluate the response rate of extra-CNS lesions according to RECIST. Measure every 9 weeks until best response recorded
Measured: 1 year
Vascular activity of brain metastatic tumors after bevacizumab treatment
vascular activity detected with dynamic contrast enhanced magnetic resonance imaging (DCE-MRI), measured before treatment, 24 hours after bevacizumab administration and end of 1st cycle of B-EP
Measured: 4 weeks
Biomarkers in CSF and serum in patients with brain and/or leptomeningeal metastasis receiving B-EP
Prognostic and predictive value of biomarkers in CSF or serum. Serum will be drawn before treatment, end of cycle one and end of 6 cycles of treatment or time of progression
Measured: Before the start of treatment till the end of treatment (after 6 cycles or progression)
Drug concentrations of etoposide and cisplatin
Drug concentrations of bevacizumab, etoposide in CSF, blood and CSF/blood ratio before and after B-EP treatment in cycle one and cycle two
Measured: 12 weeks
Association between response of CNS metastasis and the history of prior exposure to cisplatin
To evaluate the response rate and duration of response of CNS metastasis regarding to prior exposure to cisplatin
Measured: 1 year
Proton MR spectroscopy of metastatic brain tumor before and after B-EP treatment
To evaluate the characteristics of 1H-MRS of metastatic brain tumor before and after B-EP treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Taichung Veterans General Hospital, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Yen-Shen Lu, MD, PhD, Principal investigator, Department of Oncology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281696
- Sponsor's protocol ID
- 201010077M
- Status last verified
- Oct 2013
- First submitted
- 24 Dec 2010
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen BB, Lu YS, Lin CH, Chen WW, Wu PF, Hsu CY, Yu CW, Wei SY, Cheng AL, Shih TT. A pilot study to determine the timing and effect of bevacizumab on vascular normalization of metastatic brain tumors in breast cancer. BMC Cancer. 2016 Jul 13;16:466. doi: 10.1186/s12885-016-2494-8.
PubMed 27412562Wu PF, Lin CH, Kuo CH, Chen WW, Yeh DC, Liao HW, Huang SM, Cheng AL, Lu YS. A pilot study of bevacizumab combined with etoposide and cisplatin in breast cancer patients with leptomeningeal carcinomatosis. BMC Cancer. 2015 Apr 17;15:299. doi: 10.1186/s12885-015-1290-1.
PubMed 25928457
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Bevacizumab With Etoposide and Cisplatin in Breast Cancer Patients With Brain and/or Leptomeningeal Metastasis
- ClinicalTrials.gov ID
- NCT01281696
- Acronym / sponsor ID
- 201010077M
- Keywords
- Breast cancer, CNS metastasis, Brain metastasis, Leptomeningeal metastasis, Bevacizumab, Etoposide, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Taichung Veterans General Hospital, Chang Gung Memorial Hospital
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Jan 2011 (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 main purpose of this study is to investigate the efficacy of bevacizumab, etoposide and cisplatin in treating breast cancer patients with central nervous system metastasis (including brain parenchymal and leptomeningeal metastasis).
Detailed description
Brain metastases are increasingly important causes of morbidity and mortality in breast cancer patients. Whole brain radiotherapy (WBRT) and surgery remains the standard treatment for brain metastases. However, the median overall survival after brain and leptomeningeal metastasis were only 8.5 months and 16 weeks respectively There is lack of standard treatment for brain metastasis progression post WBRT. Chemotherapy was considered mostly poor for treatment response because of the blood brain barrier. However, this has been questioned because tumor can disrupt the normal function of blood brain barrier. For example, etoposide and cisplatin had been used for treatment for breast cancer patients with brain metastasis. The overall response rate of central nervous system (CNS) was 39 %, disease control rate was 60%, although the median overall survival was 31 weeks only. The role of targeted therapies is actively being assessed. Recently, a phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer showed that CNS objective response rates were 6% to lapatinib monotherapy and 20% to lapatinib plus capecitabine. Although the result is promising, the treatment population is limited in the HER2 overexpression breast cancer.
Bevacizumab, an anti-angiogenic agent, has been approved to combine with several chemotherapy agents in breast, lung and colon cancer. It was once considered contraindicated in patients with brain metastases due to the possibility of intracranial bleeding. However, two studies involving the use of bevacizumab for treating brain metastatic tumors of non-squamous or peripherally located squamous lung cancer showed no report of brain hemorrhage. In addition, bevacizumab has been approved to treat primary brain aggressive tumors recently.
In the institution, the investigators treated three breast cancer patients with multiple brain metastases using bevacizumab plus etoposide and cisplatin (B-EP). All of them have been treated for at least two lines of chemotherapy before brain metastases occurred. All of them received WBRT for brain metastases and one of them also received craniotomy with brain tumor resection plus local stereotactic radiosurgery. The follow up magnetic resonance imaging (MRI) had revealed recurrent metastatic brain tumors in one patients, and recurrence of leptomeningeal metastasis in another two patients. One patient who has multiple brain parenchyma metastases showed objective response on MRI after two cycle of B-EP treatment, and remained progression free for more than 5 months. The other two patients with leptomeningeal metastasis had intrathecal and intraventricular (via Ommaya reservoir) methotrexate treatment for more than eight doses. They were near stupor before B-EP treatment. Both had best clinical response of full recovery of consciousness and absence of cancer cells in cerebrospinal fluid. One survived eight months after the diagnosis leptomeningeal metastasis, and the other two were still alive six months after the diagnosis of leptomeningeal metastasis .
Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) has been used in various studies for evaluation of anti-angiogenic condition. In breast cancer, DCE-MRI has been used as an early predictive marker for response. Glioblastoma patients have also been evaluated with DCE-MRI to determine reduction of vessel permeability after bevacizumab treatment.
Proton magnetic resonance spectroscopy (1H-MRS) has been used to different benign brain tumors from malignant ones. The utilization of 1H-MRS, especially in human brain tumors, coupled to both routine MRI and functional MRI techniques provides greater information concerning tumor grading and extension and characterization of the normal surrounding tissue than what is possible with any other imaging technique alone. To analyze proton spectroscopy before and after bevacizumab may give us further information about the mechanism of B-EP on CNS metastasis.
Therefore, the investigators propose to conduct a phase II clinical trial to test the efficacy of B-EP regimen in breast cancer patients with CNS metastasis along with brain DCE-MRI to demonstrate the antiangiogenesis efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab, etoposide, cisplatin (BEEP) | Experimental | Drug: Bevacizumab, etoposide, cisplatin, Drug: Intrathecal methotrexate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- A histological confirmed invasive breast cancer
- Patient with at least one measurable brain metastatic tumor (≧10mm on T1-weighted gadolinium enhanced MRI or contrast-enhanced CT) or leptomeningeal metastasis with positive CSF cytology study.
- Patient whose brain parenchymal metastatic tumors either progress after WBRT, develop new lesions after WBRT, or CNS metastatic tumor do not response to WBRT according to image study 3 months after treatment. Patients with leptomeningeal metastasis does not necessarily need whole brain radiotherapy before enrollment.
- Patients with Her2/neu overexpression or amplification will be allowed but will be informed about other available treatment options such as lapatinib plus capecitabine.
- Patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:
Key exclusion criteria (20 listed)
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy
- Patients whose CNS metastasis progressed or developed during prior cisplatin treatment
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- History of thrombotic disorders
- Active gastrointestinal bleeding
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 |
|---|---|---|
| Bevacizumab, etoposide, cisplatinAlso: Bevacizumab (Avastin)Bevacizumab (15mg/kg) on D1, etoposide (70mg/m2) on D2-D4, cisplatin (70mg/m2) on D2; 21 days a cycle, for a maximum of 6 cycles | Drug | Bevacizumab, etoposide, cisplatin (BEEP) |
| Intrathecal methotrexateAlso: MethotrexateAdditional intrathecal methotrexate only given in patients with leptomeningeal metastasis | Drug | Bevacizumab, etoposide, cisplatin (BEEP) |
Primary outcome
Response rate of central nervous system (CNS) metastasis
Time frame: 1 year
The response criteria for brain parenchymal metastasis is measured according to the volumetric response criteria with modification. CNS lesion(s) which have a ≧ 50% volumetric reduction of in the absence of progressive neurologic signs and symptoms will be considered as responsive. The response criteria for leptomeningeal metastasis is defined as disappearance of carcinoma cells of three consecutive cytology examination of cerebrospinal fluid (CSF) after chemotherapy. For patients with both brain and leptomeningeal metastases, both criteria need to be met to be considered as responsive.
9 secondary outcomes
Number of participants with adverse events
Time frame: Baseline to until one month after last course of chemotherapy protocol treatment
To evaluate the response rate of breast cancer patients with brain parenchymal metastasis after receiving B-EP
Time frame: 1 year
To evaluate the response rate of breast cancer patients with leptomeningeal carcinomatosis after receiving B-EP
Time frame: 1 year
To evaluate the response rate of extra-CNS lesions according to RECIST
Time frame: 1 year
Vascular activity of brain metastatic tumors after bevacizumab treatment
Time frame: 4 weeks
Biomarkers in CSF and serum in patients with brain and/or leptomeningeal metastasis receiving B-EP
Time frame: Before the start of treatment till the end of treatment (after 6 cycles or progression)
Drug concentrations of etoposide and cisplatin
Time frame: 12 weeks
Association between response of CNS metastasis and the history of prior exposure to cisplatin
Time frame: 1 year
Proton MR spectroscopy of metastatic brain tumor before and after B-EP treatment
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
- Derived from this study: PubMed 27412562Chen BB, Lu YS, Lin CH, Chen WW, Wu PF, Hsu CY, Yu CW, Wei SY, Cheng AL, Shih TT. A pilot study to determine the timing and effect of bevacizumab on vascular normalization of metastatic brain tumors in breast cancer. BMC Cancer. 2016 Jul 13;16:466. doi: 10.1186/s12885-016-2494-8.
- Derived from this study: PubMed 25928457Wu PF, Lin CH, Kuo CH, Chen WW, Yeh DC, Liao HW, Huang SM, Cheng AL, Lu YS. A pilot study of bevacizumab combined with etoposide and cisplatin in breast cancer patients with leptomeningeal carcinomatosis. BMC Cancer. 2015 Apr 17;15:299. doi: 10.1186/s12885-015-1290-1.
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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.
Yen-Shen Lu, MD, PhD principal investigator
Department of Oncology, National Taiwan University 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 Bevacizumab, etoposide, cisplatin and Intrathecal methotrexate in people with Breast Neoplasms and Leptomeningeal Metastasis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 19 inclusion and 20 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: finished, as of the sponsor's last update on 16 Oct 2013. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate of central nervous system (CNS) metastasis (time frame: 1 year). 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 NCT01281696, which also lists 2 linked publications.
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 16 Oct 2013.