Breast CancerPhase 2A-PlusNCT02185352
Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy in Breast Cancer With Brain Metastases
A Phase 2 study testing BEEP regimen in people with Breast Cancer and Brain Metastases, run by National Taiwan University Hospital at 8 sites in Taiwan.
Trial summary
The primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole bran radiotherapy (WBRT) with WBRT alone in the controlling of brain metastases (BM) in metastatic breast cancer (MBC) patients who have… Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Brain Metastases
- What is being tested?
- BEEP regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 8 sitesTaiwan
- Study dates
- 21 Apr 2014to Nov 2022
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A histological confirmed invasive breast cancer.
- At least one measurable brain metastatic tumor. If the measurable brain lesion has previously received stereotactic radiosurgery, the tumor must be a progressive lesion after radiosurgery.
- Patients who had not received WBRT.
- Patients with HER2/neu overexpression or amplification and had received trastuzumab before the diagnosis of BM will be allowed but will be informed about other available treatment options such as lapatinib plus capecitabine.
- Karnofsky performance score (KPS) higher or equal to 30%.
- Patients must have adequate organ function and marrow reserve measured within 14 days prior to randomization
Show all 11Show fewer
- Age 20 to 75 years.
- Patient's life expectancy is more than 3 months.
- 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 6 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 who have history of disease progression or disease developed during prior cisplatin treatment.
- Patients who had leptomeningeal metastasis, either diagnosed by brain imaging study or confirmed by cerebrospinal fluid cytology examination.
- Patients who are eligible for and willing to receive brain surgery or stereotactic radiosurgery (SRS) as the initial treatment of BM.
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- History of thrombotic disorders.
Show all 22Show fewer
- Active gastrointestinal bleeding.
- Patients with a history of self-reported intra-cranial hemorrhage or evidence of bleeding in previous cranial imaging.
- 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 occlusive disease.
- Arterial thromboembolic event within the past 6 months, including transient ischemic attack, cerebrovascular accident, unstable angina, or myocardial infarction.
- History of gross hemoptysis (e.g., ≥ 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 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
8 sites in 1 country.
8 sites in 1 country
Taiwan8 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Shuang Ho Hospital
New Taipei City
China Medical University Hospital
Taichung
National Taiwan University Hospital
Taipei, 100
Tri-Service General Hospital
Taipei, 114
Mackay Memorial Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital-LinKou
Taoyuan
About this study
Official title: Randomized Phase II Study of Induction Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy (WBRT) Versus WBRT Alone in Breast Cancer With Untreated Brain Metastases
The primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole bran radiotherapy (WBRT) with WBRT alone in the controlling of brain metastases (BM) in metastatic breast cancer (MBC) patients who have not previously received WBRT.
In past 2 years, the research team has demonstrated that BEEP regimen is a highly effective treatment for brain metastases of breast cancer progressing from WBRT by a multi-center phase II study (ClinicalTrials.gov Identifier: NCT01281696). The basic concept of preconditioning, as referred to starting bevacizumab 1 day before chemotherapy, is that the effect of bevacizumab induced tumor vascular normalization takes time to mature.
The investigators hypothesized that as induction BEEP decreased the size of brain tumors, the effectiveness of WBRT would be maximized. The investigators expect this integrated approach will do greater benefit to MBC patients with BM, irrespective of subtype.
Read the detailed description
Brain metastasis (BM) occurs in about 20% to 35% of metastatic breast cancer (MBC) patients. In contrast to recent advances in systemic treatment of MBC, there is much room for improvement in treatment of BM. At present, the standard treatment for inoperable/not suitable for radiosurgery BM is whole-brain radiotherapy (WBRT), but with only a median overall survival (OS) of 6 to 12 months and a high brain relapse rate ranging from 30% to 100%.
In MBC, 70% to 80% of patients with BM are presented with more than two brain metastatic tumors and are not candidate for both surgical treatment and stereotactic radiosurgery (SRS). Unlike patients with solitary or oligo-brain metastatic tumors, for whom the addition of local treatments such as surgery or SRS has been shown to improve OS and relapse rate; for patients with multiple brain metastases, WBRT remained the only standard treatment and improvements are desperately awaited.
Brain was once considered as a "sanctuary" area for systemic drugs due to the protection of blood-brain-barrier (BBB). Although some preclinical studies suggest that the BBB could be disrupted during the growth of brain metastatic tumor, the amount of chemotherapy drugs be delivered to brain tissue was still far lower than that could be achieved in serum. Bevacizumab, a vascular endothelial growth factor antibody, has shown the ability to "normalize" the peri-tumoral vessels in preclinical models. The investigators hypothesized that with the addition of bevacizumab, the chemotherapy drugs-etoposide and cisplatin, which were shown also to have some activity for BM-will be delivered more efficiently into the once "sanctuary" brain parenchyma, thus increasing the efficacy of BM treatment.
Recently, the research team have demonstrated that bevacizumab preconditioning followed by etoposide and cisplatin (BEEP) is a highly effective treatment for brain metastases of breast cancer progressing from radiotherapy by a multi-center phase II study. The basic concept of preconditioning, as referred to starting bevacizumab 1 day before chemotherapy, is that normalization effect takes time to mature. In that study, 35 patients were enrolled. Twenty seven patients (77.2%; 95%CI 59.9-89.6) achieved brain tumor volumetric response, defined as a ≥50% reduction in the volumetric sum of all measurable brain lesions in the absence of increasing steroid use, development of new brain lesion, or progressive neurologic symptoms. With a median follow-up of 11.0 months, the median CNS progression free survival (PFS) was 6.7 months (95% CI 5.1 to 8.3 months), and OS was 9.4 months (95% CI 7.3 to 11.5 months).
At present, lapatinib is the only molecular targeted agent proven effective for MBC patients with BM. The CNS response rate of first-line lapatinib plus capecitabine was 65% in WBRT-naïve, HER2-positive MBC patients with BM. However, the median CNS PFS is still disappointingly short at 5.5 months and the result is limited to MBC patients who are HER2-positive.
It has been demonstrated that brain tumor size is a predictor of WBRT failure. Given the high response rate of BEEP for BM in our phase II trial, the investigators hypothesized that as induction BEEP decreased the size of BM, the effectiveness of WBRT would also be enhanced. This integrated approach will do greater benefit to MBC patients with BM, irrespective of subtype. Hence, the investigators plan to conduct this randomized phase II trial to evaluate the efficacy of induction BEEP followed by WBRT.
Sub study of A-PLUS: A Integrated Study of MRI and PET of The Brain in Evaluation of Neurocognitive Outcomes of Patients with Brain Metastasis Treated by Radiotherapy and Chemotherapy.
The participants of A-PLUS trial may be enrolled in an additional study of this trial. This additional prospective study aims to investigate the neurocognitive outcomes of patients with brain metastases treated by radiotherapy and chemotherapy. The evaluations include neurocognitive assessments, serial MRI and FDG PET-CT (Integrated MR-PET) at before and after the study treatment. A total of 80 participants will be enrolled. The study protocol was approved by the NTUH REC, No. 201412046MINA.
- Conditions
- Breast Cancer, Brain Metastases
- Being tested
- BEEP regimen
- Keywords
- Bevacizumab, Brain Metastases, Breast Cancer, Chemotherapy, Whole Brain Radiotherapy
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEEP regimenDrug
Also called Bevacizumab, Etoposide, Cisplatin
Bevacizumab 15mg/kg IVF on D1, Etoposide 70 mg/m2 IVF QD, D2-4, Cisplatin 70 mg/m2 IVF on D2, repeat every 3 weeks, for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Inductional BEEP regimen | Experimental | Induction BEEP regimen:
Every 3 weeks a cycle for a total of 3 cycles (around 2 months)
* Bevacizumab 15mg/kg IVF on D1
* Etoposide 70 mg/m2 IVF QD, D2-4
* Cisplatin 70 mg/m2 IVF on D2
WBRT:
3000cGy in 10 fractions Receives: Drug: BEEP regimen |
| WBRT alone | No intervention | standard WBRT: 3000cGy in 10 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Brain-specific progression free survival (BS-PFS)
To evaluate and compare the brain-specific progression free survival (BS-PFS) of the two treatment arms based on RECIST 1.1.
Measured: 2.5 years
Secondary outcomes (1)
The 2-month brain-specific objective response rate (BS-ORR)
To compare the 2-month brain-specific objective response rate (BS-ORR) of the two treatment arms based on volumetric analysis (CNS composite response criteria).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start21 Apr 2014
- Primary completion1 Nov 2019
- Study completionNov 2022 (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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen-Shen Lu, M.D, Ph.D., Principal investigator, National Taiwan Unversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185352
- Sponsor's protocol ID
- 201402059MIPD
- Acronym
- A-Plus
- Status last verified
- May 2021
- First submitted
- 25 Jun 2014
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen TW, Dai MS, Tseng LM, Chen SC, Chao TY, Chao TC, Chang YC, Chiu CF, Liu CT, Lin CH, Liu CY, Chen YF, Chang DY, Yu JC, Rau KM, Hsieh YY, Shen SC, Huang SM, Cheng AL, Lu YS. Whole-Brain Radiotherapy Alone vs Preceded by Bevacizumab, Etoposide, and Cisplatin for Untreated Brain Metastases From Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2024 Mar 1;10(3):325-334. doi: 10.1001/jamaoncol.2023.5456.
PubMed 38127335
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Induction Bevacizumab, Etoposide and Cisplatin Followed by Whole Brain Radiotherapy (WBRT) Versus WBRT Alone in Breast Cancer With Untreated Brain Metastases
- ClinicalTrials.gov ID
- NCT02185352
- Acronym / sponsor ID
- A-Plus / 201402059MIPD
- Conditions
- Breast Cancer, Brain Metastases
- Keywords
- Bevacizumab, Brain Metastases, Breast Cancer, Chemotherapy, Whole Brain Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2014 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- Nov 2022 (estimated)
- First posted
- 9 Jul 2014 (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 primary objective of A-PLUS trial is to evaluate and compare the efficacy of induction BEEP (bevacizumab preconditioning followed by etoposide and cisplatin) followed by whole bran radiotherapy (WBRT) with WBRT alone in the controlling of brain metastases (BM) in metastatic breast cancer (MBC) patients who have not previously received WBRT.
In past 2 years, the research team has demonstrated that BEEP regimen is a highly effective treatment for brain metastases of breast cancer progressing from WBRT by a multi-center phase II study (ClinicalTrials.gov Identifier: NCT01281696). The basic concept of preconditioning, as referred to starting bevacizumab 1 day before chemotherapy, is that the effect of bevacizumab induced tumor vascular normalization takes time to mature.
The investigators hypothesized that as induction BEEP decreased the size of brain tumors, the effectiveness of WBRT would be maximized. The investigators expect this integrated approach will do greater benefit to MBC patients with BM, irrespective of subtype.
Detailed description
Brain metastasis (BM) occurs in about 20% to 35% of metastatic breast cancer (MBC) patients. In contrast to recent advances in systemic treatment of MBC, there is much room for improvement in treatment of BM. At present, the standard treatment for inoperable/not suitable for radiosurgery BM is whole-brain radiotherapy (WBRT), but with only a median overall survival (OS) of 6 to 12 months and a high brain relapse rate ranging from 30% to 100%.
In MBC, 70% to 80% of patients with BM are presented with more than two brain metastatic tumors and are not candidate for both surgical treatment and stereotactic radiosurgery (SRS). Unlike patients with solitary or oligo-brain metastatic tumors, for whom the addition of local treatments such as surgery or SRS has been shown to improve OS and relapse rate; for patients with multiple brain metastases, WBRT remained the only standard treatment and improvements are desperately awaited.
Brain was once considered as a "sanctuary" area for systemic drugs due to the protection of blood-brain-barrier (BBB). Although some preclinical studies suggest that the BBB could be disrupted during the growth of brain metastatic tumor, the amount of chemotherapy drugs be delivered to brain tissue was still far lower than that could be achieved in serum. Bevacizumab, a vascular endothelial growth factor antibody, has shown the ability to "normalize" the peri-tumoral vessels in preclinical models. The investigators hypothesized that with the addition of bevacizumab, the chemotherapy drugs-etoposide and cisplatin, which were shown also to have some activity for BM-will be delivered more efficiently into the once "sanctuary" brain parenchyma, thus increasing the efficacy of BM treatment.
Recently, the research team have demonstrated that bevacizumab preconditioning followed by etoposide and cisplatin (BEEP) is a highly effective treatment for brain metastases of breast cancer progressing from radiotherapy by a multi-center phase II study. The basic concept of preconditioning, as referred to starting bevacizumab 1 day before chemotherapy, is that normalization effect takes time to mature. In that study, 35 patients were enrolled. Twenty seven patients (77.2%; 95%CI 59.9-89.6) achieved brain tumor volumetric response, defined as a ≥50% reduction in the volumetric sum of all measurable brain lesions in the absence of increasing steroid use, development of new brain lesion, or progressive neurologic symptoms. With a median follow-up of 11.0 months, the median CNS progression free survival (PFS) was 6.7 months (95% CI 5.1 to 8.3 months), and OS was 9.4 months (95% CI 7.3 to 11.5 months).
At present, lapatinib is the only molecular targeted agent proven effective for MBC patients with BM. The CNS response rate of first-line lapatinib plus capecitabine was 65% in WBRT-naïve, HER2-positive MBC patients with BM. However, the median CNS PFS is still disappointingly short at 5.5 months and the result is limited to MBC patients who are HER2-positive.
It has been demonstrated that brain tumor size is a predictor of WBRT failure. Given the high response rate of BEEP for BM in our phase II trial, the investigators hypothesized that as induction BEEP decreased the size of BM, the effectiveness of WBRT would also be enhanced. This integrated approach will do greater benefit to MBC patients with BM, irrespective of subtype. Hence, the investigators plan to conduct this randomized phase II trial to evaluate the efficacy of induction BEEP followed by WBRT.
Sub study of A-PLUS: A Integrated Study of MRI and PET of The Brain in Evaluation of Neurocognitive Outcomes of Patients with Brain Metastasis Treated by Radiotherapy and Chemotherapy.
The participants of A-PLUS trial may be enrolled in an additional study of this trial. This additional prospective study aims to investigate the neurocognitive outcomes of patients with brain metastases treated by radiotherapy and chemotherapy. The evaluations include neurocognitive assessments, serial MRI and FDG PET-CT (Integrated MR-PET) at before and after the study treatment. A total of 80 participants will be enrolled. The study protocol was approved by the NTUH REC, No. 201412046MINA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inductional BEEP regimen | Experimental | Drug: BEEP regimenInduction BEEP regimen: Every 3 weeks a cycle for a total of 3 cycles (around 2 months) * Bevacizumab 15mg/kg IVF on D1 * Etoposide 70 mg/m2 IVF QD, D2-4 * Cisplatin 70 mg/m2 IVF on D2 WBRT: 3000cGy in 10 fractions |
| WBRT alone | No intervention | –standard WBRT: 3000cGy in 10 fractions |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A histological confirmed invasive breast cancer.
- At least one measurable brain metastatic tumor. If the measurable brain lesion has previously received stereotactic radiosurgery, the tumor must be a progressive lesion after radiosurgery.
- Patients who had not received WBRT.
- Patients with HER2/neu overexpression or amplification and had received trastuzumab before the diagnosis of BM will be allowed but will be informed about other available treatment options such as lapatinib plus capecitabine.
- Karnofsky performance score (KPS) higher or equal to 30%.
Key exclusion criteria (22 listed)
- Prior therapy with bevacizumab, sorafenib, sunitinib, or other VEGF pathway-targeted therapy.
- Patients who have history of disease progression or disease developed during prior cisplatin treatment.
- Patients who had leptomeningeal metastasis, either diagnosed by brain imaging study or confirmed by cerebrospinal fluid cytology examination.
- Patients who are eligible for and willing to receive brain surgery or stereotactic radiosurgery (SRS) as the initial treatment of BM.
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of 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 |
|---|---|---|
| BEEP regimenAlso: Bevacizumab, Etoposide, CisplatinBevacizumab 15mg/kg IVF on D1, Etoposide 70 mg/m2 IVF QD, D2-4, Cisplatin 70 mg/m2 IVF on D2, repeat every 3 weeks, for 3 cycles | Drug | Inductional BEEP regimen |
Primary outcome
The Brain-specific progression free survival (BS-PFS)
Time frame: 2.5 years
To evaluate and compare the brain-specific progression free survival (BS-PFS) of the two treatment arms based on RECIST 1.1.
1 secondary outcome
The 2-month brain-specific objective response rate (BS-ORR)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Derived from this study: PubMed 38127335Chen TW, Dai MS, Tseng LM, Chen SC, Chao TY, Chao TC, Chang YC, Chiu CF, Liu CT, Lin CH, Liu CY, Chen YF, Chang DY, Yu JC, Rau KM, Hsieh YY, Shen SC, Huang SM, Cheng AL, Lu YS. Whole-Brain Radiotherapy Alone vs Preceded by Bevacizumab, Etoposide, and Cisplatin for Untreated Brain Metastases From Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2024 Mar 1;10(3):325-334. doi: 10.1001/jamaoncol.2023.5456.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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, M.D, Ph.D. principal investigator
National Taiwan Unversity Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BEEP regimen in people with Breast Cancer and Brain Metastases, run by National Taiwan University Hospital at 8 sites 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 11 inclusion and 22 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 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
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?
The Brain-specific progression free survival (BS-PFS) (time frame: 2.5 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 NCT02185352, 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 7 May 2021.