Breast CancerPhase 2BETTERNCT02910050

Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer

A Phase 2 study testing Bicalutamide and Aromatase Inhibitor in people with Breast Cancer, run by Xu fei at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after treatment of an aromatase inhibitor. Read more about this study

Who is it for?: Ages 18 to 80 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: Bicalutamide and Aromatase Inhibitor
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteChina
Study dates: Jan 2016to Dec 2018
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 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer
Metastatic or unresectable locally advanced disease
Age over 18 years
Postmenopausal status （continuous using luteinizing hormone releasing hormone(LHRH) analogue is available）
Patient must have disease progression after treatment of an Aromatase inhibitor.
Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-2

Show all 10Show fewer

Life expectancy over 3 months.
Measurable disease according to RECIST version 1.1 or only bone metastasis
Adequate hematological, hepatic function.
Voluntarily signed and dated written informed consent prior to any study specific procedure.

Who cannot join

Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis
Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
History of other primary malignancy
Resistant to steroidal or nonsteroidal aromatase Inhibitor

Trial locations and contacts

1 site in 1 country.

Fei Xu, MD contact

+86-13711277870

xiawen@sysucc.org.cn

China1 site, 1 recruiting

State Key Laboratory of Oncology in South China,Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fei Xu, MD, +86-13711277870, xufei@sysucc.org.cn
Recruiting

Other trials in China

About this study

Official title: A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer

Read the detailed description

Androgen receptor(AR) is closely related to molecular type, treatment and prognosis in breast cancer. Over 70% of breast cancer expressed androgen receptor. And in some estrogen receptor positive breast cancer cells which are resistant to Aromatase inhibitors can change androgen receptor dependent. So AR may be a new target in the treatment of breast cancer. Bicalutamide is a selective androgen receptor inhibitor with a clinical benefit rate of 19% and median progression free survival of 12 weeks in the ER-/AR+ metastatic breast cancer. This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER+/AR+/HER- metastatic breast cancer patients who have disease progression after treatment of an AI.

Conditions: Breast Cancer
Being tested: Bicalutamide, Aromatase Inhibitor
Keywords: androgen receptor, bicalutamide, aromatase inhibitors, advanced breast cancer, letrozole, anastrozole, exemestane
Medical subject headings: Breast Neoplasms, Bulbo-Spinal Atrophy, X-Linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BicalutamideDrug
Also called Casodex
50mg once a day orally
Aromatase InhibitorDrug
Also called letrozole, anastrozole, exemestane
participants will receive any kind of aromatase inhibitor which has not been received before (steroidal AI change to nonsteroidal AI and vice versa), Letrozole 2.5mg once a day orally, Anastrozole 1mg once a day orally, Exemestane 25mg once a day orally

Study groups in NCT02910050
Study group	Role	What they receive
bicalutamide+ Aromatase Inhibitor	Experimental	ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor Receives: Drug: Bicalutamide; Drug: Aromatase Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

clinical benefit rate（CBR）
Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 2 months for the first 6 months and then every 3 months till progression or termination of the study.CBR is defined as ratio of participants who have stable disease for over 24 weeks.
Measured: 24 weeks

Secondary outcomes (3)

progression free survival
Time from to the first documentation of objective tumor progression or to death due to any cause.
Measured: baseline up to approximately 6 months
objective response rate of bicalutamide plus another AI in participants with measurable disease
objective response rate includes complete response, partial response.
Measured: 24 weeks
tolerability of bicalutamide plus an Aromatase inhibitor
evaluate and quality of life of the participants using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) .
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Dec 2018

First posted21 Sep 2016 (estimated)
Study startJan 2016
Primary completionSep 2018 (estimated)
Study completionDec 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02910050
Sponsor's protocol ID: SYSU5010-2016
Acronym: BETTER
Status last verified: Dec 2017
First submitted: 6 Sep 2016
Last updated: 22 Dec 2017
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

Kuenen-Boumeester V, Van der Kwast TH, Claassen CC, Look MP, Liem GS, Klijn JG, Henzen-Logmans SC. The clinical significance of androgen receptors in breast cancer and their relation to histological and cell biological parameters. Eur J Cancer. 1996 Aug;32A(9):1560-5. doi: 10.1016/0959-8049(96)00112-8.
PubMed 8911118
Mangelsdorf DJ, Thummel C, Beato M, Herrlich P, Schutz G, Umesono K, Blumberg B, Kastner P, Mark M, Chambon P, Evans RM. The nuclear receptor superfamily: the second decade. Cell. 1995 Dec 15;83(6):835-9. doi: 10.1016/0092-8674(95)90199-x. No abstract available.
PubMed 8521507
Grogg A, Trippel M, Pfaltz K, Ladrach C, Droeser RA, Cihoric N, Salhia B, Zweifel M, Tapia C. Androgen receptor status is highly conserved during tumor progression of breast cancer. BMC Cancer. 2015 Nov 9;15:872. doi: 10.1186/s12885-015-1897-2.
PubMed 26552477
Brys M. Androgens and androgen receptor: do they play a role in breast cancer? Med Sci Monit. 2000 Mar-Apr;6(2):433-8.
PubMed 11208351
Witzel I, Graeser M, Karn T, Schmidt M, Wirtz R, Schutze D, Rausch A, Janicke F, Milde-Langosch K, Muller V. Androgen receptor expression is a predictive marker in chemotherapy-treated patients with endocrine receptor-positive primary breast cancers. J Cancer Res Clin Oncol. 2013 May;139(5):809-16. doi: 10.1007/s00432-013-1382-8. Epub 2013 Feb 8.
PubMed 23392859
Fujii R, Hanamura T, Suzuki T, Gohno T, Shibahara Y, Niwa T, Yamaguchi Y, Ohnuki K, Kakugawa Y, Hirakawa H, Ishida T, Sasano H, Ohuchi N, Hayashi S. Increased androgen receptor activity and cell proliferation in aromatase inhibitor-resistant breast carcinoma. J Steroid Biochem Mol Biol. 2014 Oct;144 Pt B:513-22. doi: 10.1016/j.jsbmb.2014.08.019. Epub 2014 Aug 29.
PubMed 25178713
Ciupek A, Rechoum Y, Gu G, Gelsomino L, Beyer AR, Brusco L, Covington KR, Tsimelzon A, Fuqua SA. Androgen receptor promotes tamoxifen agonist activity by activation of EGFR in ERalpha-positive breast cancer. Breast Cancer Res Treat. 2015 Nov;154(2):225-37. doi: 10.1007/s10549-015-3609-7. Epub 2015 Oct 20.
PubMed 26487496
Cuenca-Lopez MD, Montero JC, Morales JC, Prat A, Pandiella A, Ocana A. Phospho-kinase profile of triple negative breast cancer and androgen receptor signaling. BMC Cancer. 2014 Apr 30;14:302. doi: 10.1186/1471-2407-14-302.
PubMed 24779793
Garay JP, Karakas B, Abukhdeir AM, Cosgrove DP, Gustin JP, Higgins MJ, Konishi H, Konishi Y, Lauring J, Mohseni M, Wang GM, Jelovac D, Weeraratna A, Sherman Baust CA, Morin PJ, Toubaji A, Meeker A, De Marzo AM, Lewis G, Subhawong A, Argani P, Park BH. The growth response to androgen receptor signaling in ERalpha-negative human breast cells is dependent on p21 and mediated by MAPK activation. Breast Cancer Res. 2012 Feb 9;14(1):R27. doi: 10.1186/bcr3112.
PubMed 22321971
Tarulli GA, Butler LM, Tilley WD, Hickey TE. Bringing androgens up a NOTCH in breast cancer. Endocr Relat Cancer. 2014 Aug;21(4):T183-202. doi: 10.1530/ERC-14-0248. Epub 2014 Jul 7.
PubMed 25001242
Ueda T, Bruchovsky N, Sadar MD. Activation of the androgen receptor N-terminal domain by interleukin-6 via MAPK and STAT3 signal transduction pathways. J Biol Chem. 2002 Mar 1;277(9):7076-85. doi: 10.1074/jbc.M108255200. Epub 2001 Dec 19.
PubMed 11751884
Gucalp A, Tolaney S, Isakoff SJ, Ingle JN, Liu MC, Carey LA, Blackwell K, Rugo H, Nabell L, Forero A, Stearns V, Doane AS, Danso M, Moynahan ME, Momen LF, Gonzalez JM, Akhtar A, Giri DD, Patil S, Feigin KN, Hudis CA, Traina TA; Translational Breast Cancer Research Consortium (TBCRC 011). Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic Breast Cancer. Clin Cancer Res. 2013 Oct 1;19(19):5505-12. doi: 10.1158/1078-0432.CCR-12-3327. Epub 2013 Aug 21.
PubMed 23965901
Lu Q, Xia W, Lee K, Zhang J, Yuan H, Yuan Z, Shi Y, Wang S, Xu F. Bicalutamide plus Aromatase Inhibitor in Patients with Estrogen Receptor-Positive/Androgen Receptor-Positive Advanced Breast Cancer. Oncologist. 2020 Jan;25(1):21-e15. doi: 10.1634/theoncologist.2019-0564. Epub 2019 Aug 21.
PubMed 31434793

Want to know more?

Fei Xu, MD

+86-13711277870

xiawen@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT02910050
Acronym / sponsor ID: BETTER / SYSU5010-2016
Conditions: Breast Cancer
Keywords: androgen receptor, bicalutamide, aromatase inhibitors, advanced breast cancer, letrozole, anastrozole, exemestane
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 58 participants (estimated)
Lead sponsor: Xu feiUniversity, hospital or other
Collaborators: Sun Yat-sen University
Study start: Jan 2016
Primary completion: Sep 2018 (estimated)
Study completion: Dec 2018 (estimated)
First posted: 21 Sep 2016 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
bicalutamide+ Aromatase Inhibitor	Experimental	Drug: Bicalutamide, Drug: Aromatase InhibitorER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor

Who may qualify

Ages: 18 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer
Metastatic or unresectable locally advanced disease
Age over 18 years
Postmenopausal status （continuous using luteinizing hormone releasing hormone(LHRH) analogue is available）
Patient must have disease progression after treatment of an Aromatase inhibitor.

Key exclusion criteria (4 listed)

Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis
Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
History of other primary malignancy
Resistant to steroidal or nonsteroidal aromatase Inhibitor

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
BicalutamideAlso: Casodex50mg once a day orally	Drug	bicalutamide+ Aromatase Inhibitor
Aromatase InhibitorAlso: letrozole, anastrozole, exemestaneparticipants will receive any kind of aromatase inhibitor which has not been received before (steroidal AI change to nonsteroidal AI and vice versa), Letrozole 2.5mg once a day orally, Anastrozole 1mg once a day orally, Exemestane 25mg once a day orally	Drug	bicalutamide+ Aromatase Inhibitor

Primary outcome

clinical benefit rate（CBR）
Time frame: 24 weeks
Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 2 months for the first 6 months and then every 3 months till progression or termination of the study.CBR is defined as ratio of participants who have stable disease for over 24 weeks.

3 secondary outcomes

progression free survival
Time frame: baseline up to approximately 6 months
objective response rate of bicalutamide plus another AI in participants with measurable disease
Time frame: 24 weeks
tolerability of bicalutamide plus an Aromatase inhibitor
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
Background: PubMed 8911118Kuenen-Boumeester V, Van der Kwast TH, Claassen CC, Look MP, Liem GS, Klijn JG, Henzen-Logmans SC. The clinical significance of androgen receptors in breast cancer and their relation to histological and cell biological parameters. Eur J Cancer. 1996 Aug;32A(9):1560-5. doi: 10.1016/0959-8049(96)00112-8.
Background: PubMed 8521507Mangelsdorf DJ, Thummel C, Beato M, Herrlich P, Schutz G, Umesono K, Blumberg B, Kastner P, Mark M, Chambon P, Evans RM. The nuclear receptor superfamily: the second decade. Cell. 1995 Dec 15;83(6):835-9. doi: 10.1016/0092-8674(95)90199-x. No abstract available.
Background: PubMed 26552477Grogg A, Trippel M, Pfaltz K, Ladrach C, Droeser RA, Cihoric N, Salhia B, Zweifel M, Tapia C. Androgen receptor status is highly conserved during tumor progression of breast cancer. BMC Cancer. 2015 Nov 9;15:872. doi: 10.1186/s12885-015-1897-2.
Background: PubMed 11208351Brys M. Androgens and androgen receptor: do they play a role in breast cancer? Med Sci Monit. 2000 Mar-Apr;6(2):433-8.
Background: PubMed 23392859Witzel I, Graeser M, Karn T, Schmidt M, Wirtz R, Schutze D, Rausch A, Janicke F, Milde-Langosch K, Muller V. Androgen receptor expression is a predictive marker in chemotherapy-treated patients with endocrine receptor-positive primary breast cancers. J Cancer Res Clin Oncol. 2013 May;139(5):809-16. doi: 10.1007/s00432-013-1382-8. Epub 2013 Feb 8.
Background: PubMed 25178713Fujii R, Hanamura T, Suzuki T, Gohno T, Shibahara Y, Niwa T, Yamaguchi Y, Ohnuki K, Kakugawa Y, Hirakawa H, Ishida T, Sasano H, Ohuchi N, Hayashi S. Increased androgen receptor activity and cell proliferation in aromatase inhibitor-resistant breast carcinoma. J Steroid Biochem Mol Biol. 2014 Oct;144 Pt B:513-22. doi: 10.1016/j.jsbmb.2014.08.019. Epub 2014 Aug 29.
Background: PubMed 26487496Ciupek A, Rechoum Y, Gu G, Gelsomino L, Beyer AR, Brusco L, Covington KR, Tsimelzon A, Fuqua SA. Androgen receptor promotes tamoxifen agonist activity by activation of EGFR in ERalpha-positive breast cancer. Breast Cancer Res Treat. 2015 Nov;154(2):225-37. doi: 10.1007/s10549-015-3609-7. Epub 2015 Oct 20.
Background: PubMed 24779793Cuenca-Lopez MD, Montero JC, Morales JC, Prat A, Pandiella A, Ocana A. Phospho-kinase profile of triple negative breast cancer and androgen receptor signaling. BMC Cancer. 2014 Apr 30;14:302. doi: 10.1186/1471-2407-14-302.
Background: PubMed 22321971Garay JP, Karakas B, Abukhdeir AM, Cosgrove DP, Gustin JP, Higgins MJ, Konishi H, Konishi Y, Lauring J, Mohseni M, Wang GM, Jelovac D, Weeraratna A, Sherman Baust CA, Morin PJ, Toubaji A, Meeker A, De Marzo AM, Lewis G, Subhawong A, Argani P, Park BH. The growth response to androgen receptor signaling in ERalpha-negative human breast cells is dependent on p21 and mediated by MAPK activation. Breast Cancer Res. 2012 Feb 9;14(1):R27. doi: 10.1186/bcr3112.
Background: PubMed 25001242Tarulli GA, Butler LM, Tilley WD, Hickey TE. Bringing androgens up a NOTCH in breast cancer. Endocr Relat Cancer. 2014 Aug;21(4):T183-202. doi: 10.1530/ERC-14-0248. Epub 2014 Jul 7.
Background: PubMed 11751884Ueda T, Bruchovsky N, Sadar MD. Activation of the androgen receptor N-terminal domain by interleukin-6 via MAPK and STAT3 signal transduction pathways. J Biol Chem. 2002 Mar 1;277(9):7076-85. doi: 10.1074/jbc.M108255200. Epub 2001 Dec 19.
Background: PubMed 23965901Gucalp A, Tolaney S, Isakoff SJ, Ingle JN, Liu MC, Carey LA, Blackwell K, Rugo H, Nabell L, Forero A, Stearns V, Doane AS, Danso M, Moynahan ME, Momen LF, Gonzalez JM, Akhtar A, Giri DD, Patil S, Feigin KN, Hudis CA, Traina TA; Translational Breast Cancer Research Consortium (TBCRC 011). Phase II trial of bicalutamide in patients with androgen receptor-positive, estrogen receptor-negative metastatic Breast Cancer. Clin Cancer Res. 2013 Oct 1;19(19):5505-12. doi: 10.1158/1078-0432.CCR-12-3327. Epub 2013 Aug 21.
Individual participant dataSharing planned: No

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.

Fei Xu, MD contact

+86-13711277870

xiawen@sysucc.org.cn

Fei Xu, MD principal investigator

Sun Yat-Sen University Cancer Center

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 Bicalutamide and Aromatase Inhibitor in people with Breast Cancer, run by Xu fei 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 10 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 22 Dec 2017. 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 Fei Xu, MD (+86-13711277870, xiawen@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

clinical benefit rate（CBR） (time frame: 24 weeks). 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 NCT02910050, which also lists 13 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 22 Dec 2017.