HR Positive/HER2 Low Expression Metastatic Breast CancerPhase 3NCT05904964

Disitamab Vedotin (RC48) in Hormone Receptor Positive, HER2-low Metastatic Breast Cancer (the Rosy Trial)

A Phase 3 study testing Disitamab vedotin and Endocrine therapy in people with HR Positive/HER2 Low Expression Metastatic Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: HR Positive/HER2 Low Expression Metastatic Breast Cancer
What is being tested?: Disitamab vedotin and Endocrine therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 3 sitesChina
Study dates: 1 Jul 2023to 1 Mar 2030
Phase: Phase 3
Are there results?: Not yet: the study is under way

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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult female patients (aged 18-70 years, including 18 and 70 years) with metastatic breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure;
Pathological examination confirmed that ER and / or PR were positive, and HER-2 was low expression (ER expression: immunohistochemical staining of tumor cells ≥ 10%; PR expression: immunohistochemical staining of tumor cells ≥ 10%; HER2-low: immunohistochemical staining of 2 + and FISH is not expanded, IHC 1 +);
Patients who have received endocrine therapy ;
According to the efficacy evaluation criteria for solid tumors (RECIST) version 1.1, there is at least one evaluable target lesion or only osteolytic bone metastasis;
Patients with stable brain metastasis or asymptomatic brain metastasis;
ECOG physical condition score ≤ 2 points, and the estimated survival time is not less than 3 months;

Show all 10Show fewer

Prior treatment-related toxicity must be relieved to ≤ 1 degree (according to NCI CTCAE 5.0) before enrollment (except for hair loss or other toxicity that is considered as no risk to the safety of patients according to the judgment of the researcher);
Adequate bone marrow functional reserve: a. WBC ≥ 3.0 × 10 ^ 9 ／ L, b. Neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 ／ L, c. Platelet count (PLT) ≥ 70 × 10^9／L;
Liver, kidney and heart function tests were basically normal within one week before enrollment (based on the normal values of laboratories in each research center): A. total bilirubin (TBIL) ≤ 1.5 × upper limit of normal value (ULN), B. alanine aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln), C. serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; d. left ventricular ejection fraction (LVEF) ≥ 55%, e. QTcF(Fridericia correction) ≤ 470 ms;
Patients understand the research process, voluntarily participate in the research, and sign the informed consent form.

Who cannot join

Patients who had received chemotherapy, radiotherapy, immunotherapy, and endocrine therapy for breast cancer within 2 weeks before enrollment.;
Patients who had performed major surgery within 2 weeks before enrollment.
Severe heart disease or discomfort within 12 months, including, but not limited to, the following: unstable angina pectoris, myocardial infarction, cerebral hemorrhage and cerebral infarction (except for silent lacunar cerebral infarction without treatment);
Have active autoimmune diseases (such as corticosteroids or immunosuppressive drugs) requiring systemic treatment in the past 2 years, excluding those with adrenal insufficiency requiring corticosteroid replacement therapy;
Have a clear history of neurological or mental disorders, including epilepsy or dementia;
According to the judgment of the researchers, there are some accompanying diseases that seriously endanger the safety of patients or affect patients to complete the study.
Those who have been known to have allergic history to Disitamab Vedotin or similar drugs;
According to the estimation of the investigator , the patient's compliance with the clinical study is insufficient or the researcher believes that there are other factors that are not suitable for the study.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Wang contact

86-20-34070870

wangy556@mail.sysu.edu.cn

Jianli Zhao contact

86-20-34070499

zhaojli5@mail.sysu.edu.cn

China3 sites, 3 recruiting

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Ying Wang, 020-34070870, wangy556@mail.sysu.edu.cn
Jianli Zhao, 020-34070499, zhaojli5@mail.sysu.edu.cn
Recruiting
Hainan Qionghai People's Hospital
Qionghai, Hainan, 571400
Jianbao Wang
Recruiting
The Second Affiliated Hospital， Shantou University Medical College
Shantou, Guangdong, 515000
Zhiyang Li
Recruiting

Other trials in China

About this study

Official title: Disitamab Vedotin or Endocrine Therapy for Patients With Metastatic Breast Cancer With Hormone Receptor-positive and HER2-low-expression

Hormone receptor positive, HER2-low expression metastatic breast cancer is the main type of breast cancer, accounting for about 50% - 60%. However, this type of patients lack ideal therapeutic drugs after the failure of first-line standard endocrine therapy, and the median overall survival time is only 30 months. Therefore, finding more efficient and safe therapeutic drugs for these patients has become a big clinical challenge at present. Disitamab Vedotin (DV), as a new class I Antibody-Drug Conjugates drug, can achieve high efficiency and precise tumor killing effect with low toxicity. According to previous study with same sample size, DV also showed good efficacy in metastatic breast cancer with Hormone receptor positive and HER2- low expression as a posterior line treatment.Therefore, we intend to explore the efficacy and safety of DV in the treatment of HER2-low expressioin /Hormone receptor positive metastatic breast cancer patients with endocrine resistance through a scientifically designed, randomized, phase III clinical study.

Conditions: HR Positive/HER2 Low Expression Metastatic Breast Cancer
Being tested: Disitamab vedotin, Endocrine therapy
Keywords: HR positive, HRE2 low expression, metastatic breast cancer, ADC
Medical subject headings: Breast Neoplasms

What participants receive

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

Disitamab vedotinDrug
Also called RC48
Disitamab Vedotin 2mg/kg was injected every 2 weeks,
Endocrine therapyOther
Doctors choose endocrine therapy independently

Study groups in NCT05904964
Study group	Role	What they receive
Disitamab Vedotin	Experimental	Disitamab Vedotin, 2mg/kg, every 2 weeks Receives: Drug: Disitamab vedotin
Endocrine therapy	Active comparator	Doctors choose endocrine therapy independently Receives: Other: Endocrine therapy

What is being measured

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

Progression free survival (PFS)
The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause.
Measured: 24 months

Secondary outcomes (9)

Overall survival (OS)
The time interval from the date of randomization to death due to any cause.
Measured: 36 months
Objective response rate (ORR)
According to recist1.1 standard, the proportion of patients whose best remission was CR or PR accounted for the total number of evaluable patients.
Measured: 12 months
Disease Control Rate (DCR)
According to recist1.1 standard, the proportion of patients whose best remission was CR or PR or SD accounted for the total number of evaluable patients.
Measured: 12 months
Clinical Benefit Rate (CBR)
According to recist1.1 standard, the proportion of patients whose best remission was CR or PR or SD ≥ 24 weeks accounted for the total number of evaluable patients.
Measured: 12 months
Quality of life assessed by EORTC-C30
Quality of life will be collected using the following questionnaire: EORTC-C30
Measured: 12 months
Psychological condition assessed by GAD-7
Measured: 12 months
Pittsburgh Sleep Scale
Measured: 12 months
Incidence of adverse events(AE)
From the date of enrollment to one year, the incidence of adverse events in the fulvestrant combined with pyrotinib group was compared with that of capecitabine combined with pyrotinib group.
Measured: from the date of enrollment to one year
Biomarkers and treatment sensitivity analysis
Cox univariate and multivariate analysis will be used to explore the correlation between endocrine and HER2 pathway related biomarkers and treatment sensitivity（The biomarkers to be analyzed included 324 tumor related genes included in the FoundationOne CDx, and ER/PR/HER2/ki67 in IHC）
Measured: 12 months

Timeline

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

1 Jul 20231 Mar 2030

First posted15 Jun 2023
Study start1 Jul 2023 (estimated)
Primary completion1 Mar 2028 (estimated)
Study completion1 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for HR Positive/HER2 Low Expression Metastatic Breast CancerStudies of the same condition, open and under way.
More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients were randomly assigned to disitamab vedotin or endocrine therapy
Masking: None (open label)
Enrolment: 288 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05904964
Sponsor's protocol ID: SYSKY-2022-208-01
Status last verified: Jun 2023
First submitted: 7 Jun 2023
Last updated: 22 Jun 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Because the data involves the patient's personal information, it is temporarily decided that we will not disclose the individual participant data.

Publications

Koleva-Kolarova RG, Oktora MP, Robijn AL, Greuter MJW, Reyners AKL, Buskens E, de Bock GH. Increased life expectancy as a result of non-hormonal targeted therapies for HER2 or hormone receptor positive metastatic breast cancer: A systematic review and meta-analysis. Cancer Treat Rev. 2017 Apr;55:16-25. doi: 10.1016/j.ctrv.2017.01.001. Epub 2017 Feb 20.
PubMed 28288388
Mendes D, Alves C, Afonso N, Cardoso F, Passos-Coelho JL, Costa L, Andrade S, Batel-Marques F. The benefit of HER2-targeted therapies on overall survival of patients with metastatic HER2-positive breast cancer--a systematic review. Breast Cancer Res. 2015 Nov 17;17:140. doi: 10.1186/s13058-015-0648-2.
PubMed 26578067
Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, Vance GH, Viale G, McShane LM, Dowsett M. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10;36(20):2105-2122. doi: 10.1200/JCO.2018.77.8738. Epub 2018 May 30.
PubMed 29846122
Giuliani S, Ciniselli CM, Leonardi E, Polla E, Decarli N, Luchini C, Cantaloni C, Gasperetti F, Cazzolli D, Berlanda G, Bernardi D, Pellegrini M, Triolo R, Ferro A, Verderio P, Barbareschi M. In a cohort of breast cancer screened patients the proportion of HER2 positive cases is lower than that earlier reported and pathological characteristics differ between HER2 3+ and HER2 2+/Her2 amplified cases. Virchows Arch. 2016 Jul;469(1):45-50. doi: 10.1007/s00428-016-1940-y. Epub 2016 Apr 21.
PubMed 27097809
Schalper KA, Kumar S, Hui P, Rimm DL, Gershkovich P. A retrospective population-based comparison of HER2 immunohistochemistry and fluorescence in situ hybridization in breast carcinomas: impact of 2007 American Society of Clinical Oncology/College of American Pathologists criteria. Arch Pathol Lab Med. 2014 Feb;138(2):213-9. doi: 10.5858/arpa.2012-0617-OA. Epub 2013 Oct 28.
PubMed 24164555
Modi S, Park H, Murthy RK, Iwata H, Tamura K, Tsurutani J, Moreno-Aspitia A, Doi T, Sagara Y, Redfern C, Krop IE, Lee C, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Takahashi S. Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low-Expressing Advanced Breast Cancer: Results From a Phase Ib Study. J Clin Oncol. 2020 Jun 10;38(17):1887-1896. doi: 10.1200/JCO.19.02318. Epub 2020 Feb 14.
PubMed 32058843
Yao X, Jiang J, Wang X, Huang C, Li D, Xie K, Xu Q, Li H, Li Z, Lou L, Fang J. A novel humanized anti-HER2 antibody conjugated with MMAE exerts potent anti-tumor activity. Breast Cancer Res Treat. 2015 Aug;153(1):123-33. doi: 10.1007/s10549-015-3503-3. Epub 2015 Aug 8.
PubMed 26253944
Ocana A, Amir E, Pandiella A. HER2 heterogeneity and resistance to anti-HER2 antibody-drug conjugates. Breast Cancer Res. 2020 Jan 31;22(1):15. doi: 10.1186/s13058-020-1252-7.
PubMed 32005279
Rios-Doria J, Harper J, Rothstein R, Wetzel L, Chesebrough J, Marrero A, Chen C, Strout P, Mulgrew K, McGlinchey K, Fleming R, Bezabeh B, Meekin J, Stewart D, Kennedy M, Martin P, Buchanan A, Dimasi N, Michelotti E, Hollingsworth R. Antibody-Drug Conjugates Bearing Pyrrolobenzodiazepine or Tubulysin Payloads Are Immunomodulatory and Synergize with Multiple Immunotherapies. Cancer Res. 2017 May 15;77(10):2686-2698. doi: 10.1158/0008-5472.CAN-16-2854. Epub 2017 Mar 10.
PubMed 28283653

Interested in taking part?

Ying Wang

86-20-34070870

wangy556@mail.sysu.edu.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 sites and contacts

RecruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
Locally Advanced or Metastatic Breast Cancer
RecruitingPhase 2
A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 2
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
Breast Cancer
RecruitingPhase 2
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer

All HR Positive/HER2 Low Expression Metastatic Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Disitamab Vedotin or Endocrine Therapy for Patients With Metastatic Breast Cancer With Hormone Receptor-positive and HER2-low-expression
ClinicalTrials.gov ID: NCT05904964
Acronym / sponsor ID: SYSKY-2022-208-01
Conditions: HR Positive/HER2 Low Expression Metastatic Breast Cancer
Keywords: HR positive, HRE2 low expression, metastatic breast cancer, ADC
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 288 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Study start: 1 Jul 2023 (estimated)
Primary completion: 1 Mar 2028 (estimated)
Study completion: 1 Mar 2030 (estimated)
First posted: 15 Jun 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Patients were randomly assigned to disitamab vedotin or endocrine therapy

Arm	Type	Receives
Disitamab Vedotin	Experimental	Drug: Disitamab vedotinDisitamab Vedotin, 2mg/kg, every 2 weeks
Endocrine therapy	Active comparator	Other: Endocrine therapyDoctors choose endocrine therapy independently

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Adult female patients (aged 18-70 years, including 18 and 70 years) with metastatic breast cancer confirmed by pathology or imaging are not suitable for surgical resection or radiotherapy for the purpose of cure;
Pathological examination confirmed that ER and / or PR were positive, and HER-2 was low expression (ER expression: immunohistochemical staining of tumor cells ≥ 10%; PR expression: immunohistochemical staining of tumor cells ≥ 10%; HER2-low: immunohistochemical staining of 2 + and FISH is not expanded, IHC 1 +);
Patients who have received endocrine therapy ;
According to the efficacy evaluation criteria for solid tumors (RECIST) version 1.1, there is at least one evaluable target lesion or only osteolytic bone metastasis;
Patients with stable brain metastasis or asymptomatic brain metastasis;

Key exclusion criteria (8 listed)

Patients who had received chemotherapy, radiotherapy, immunotherapy, and endocrine therapy for breast cancer within 2 weeks before enrollment.;
Patients who had performed major surgery within 2 weeks before enrollment.
Severe heart disease or discomfort within 12 months, including, but not limited to, the following: unstable angina pectoris, myocardial infarction, cerebral hemorrhage and cerebral infarction (except for silent lacunar cerebral infarction without treatment);
Have active autoimmune diseases (such as corticosteroids or immunosuppressive drugs) requiring systemic treatment in the past 2 years, excluding those with adrenal insufficiency requiring corticosteroid replacement therapy;
Have a clear history of neurological or mental disorders, including epilepsy or dementia;

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
Disitamab vedotinAlso: RC48Disitamab Vedotin 2mg/kg was injected every 2 weeks,	Drug	Disitamab Vedotin
Endocrine therapyDoctors choose endocrine therapy independently	Other	Endocrine therapy

Primary outcome

Progression free survival (PFS)
Time frame: 24 months
The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause.

9 secondary outcomes

Overall survival (OS)
Time frame: 36 months
Objective response rate (ORR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Clinical Benefit Rate (CBR)
Time frame: 12 months
Quality of life assessed by EORTC-C30
Time frame: 12 months
Psychological condition assessed by GAD-7
Time frame: 12 months
Pittsburgh Sleep Scale
Time frame: 12 months
Incidence of adverse events(AE)
Time frame: from the date of enrollment to one year
Biomarkers and treatment sensitivity analysis
Time frame: 12 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
Background: PubMed 28288388Koleva-Kolarova RG, Oktora MP, Robijn AL, Greuter MJW, Reyners AKL, Buskens E, de Bock GH. Increased life expectancy as a result of non-hormonal targeted therapies for HER2 or hormone receptor positive metastatic breast cancer: A systematic review and meta-analysis. Cancer Treat Rev. 2017 Apr;55:16-25. doi: 10.1016/j.ctrv.2017.01.001. Epub 2017 Feb 20.
Background: PubMed 26578067Mendes D, Alves C, Afonso N, Cardoso F, Passos-Coelho JL, Costa L, Andrade S, Batel-Marques F. The benefit of HER2-targeted therapies on overall survival of patients with metastatic HER2-positive breast cancer--a systematic review. Breast Cancer Res. 2015 Nov 17;17:140. doi: 10.1186/s13058-015-0648-2.
Background: PubMed 29846122Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, Vance GH, Viale G, McShane LM, Dowsett M. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10;36(20):2105-2122. doi: 10.1200/JCO.2018.77.8738. Epub 2018 May 30.
Background: PubMed 27097809Giuliani S, Ciniselli CM, Leonardi E, Polla E, Decarli N, Luchini C, Cantaloni C, Gasperetti F, Cazzolli D, Berlanda G, Bernardi D, Pellegrini M, Triolo R, Ferro A, Verderio P, Barbareschi M. In a cohort of breast cancer screened patients the proportion of HER2 positive cases is lower than that earlier reported and pathological characteristics differ between HER2 3+ and HER2 2+/Her2 amplified cases. Virchows Arch. 2016 Jul;469(1):45-50. doi: 10.1007/s00428-016-1940-y. Epub 2016 Apr 21.
Background: PubMed 24164555Schalper KA, Kumar S, Hui P, Rimm DL, Gershkovich P. A retrospective population-based comparison of HER2 immunohistochemistry and fluorescence in situ hybridization in breast carcinomas: impact of 2007 American Society of Clinical Oncology/College of American Pathologists criteria. Arch Pathol Lab Med. 2014 Feb;138(2):213-9. doi: 10.5858/arpa.2012-0617-OA. Epub 2013 Oct 28.
Background: PubMed 32058843Modi S, Park H, Murthy RK, Iwata H, Tamura K, Tsurutani J, Moreno-Aspitia A, Doi T, Sagara Y, Redfern C, Krop IE, Lee C, Fujisaki Y, Sugihara M, Zhang L, Shahidi J, Takahashi S. Antitumor Activity and Safety of Trastuzumab Deruxtecan in Patients With HER2-Low-Expressing Advanced Breast Cancer: Results From a Phase Ib Study. J Clin Oncol. 2020 Jun 10;38(17):1887-1896. doi: 10.1200/JCO.19.02318. Epub 2020 Feb 14.
Background: PubMed 26253944Yao X, Jiang J, Wang X, Huang C, Li D, Xie K, Xu Q, Li H, Li Z, Lou L, Fang J. A novel humanized anti-HER2 antibody conjugated with MMAE exerts potent anti-tumor activity. Breast Cancer Res Treat. 2015 Aug;153(1):123-33. doi: 10.1007/s10549-015-3503-3. Epub 2015 Aug 8.
Background: PubMed 32005279Ocana A, Amir E, Pandiella A. HER2 heterogeneity and resistance to anti-HER2 antibody-drug conjugates. Breast Cancer Res. 2020 Jan 31;22(1):15. doi: 10.1186/s13058-020-1252-7.
Background: PubMed 28283653Rios-Doria J, Harper J, Rothstein R, Wetzel L, Chesebrough J, Marrero A, Chen C, Strout P, Mulgrew K, McGlinchey K, Fleming R, Bezabeh B, Meekin J, Stewart D, Kennedy M, Martin P, Buchanan A, Dimasi N, Michelotti E, Hollingsworth R. Antibody-Drug Conjugates Bearing Pyrrolobenzodiazepine or Tubulysin Payloads Are Immunomodulatory and Synergize with Multiple Immunotherapies. Cancer Res. 2017 May 15;77(10):2686-2698. doi: 10.1158/0008-5472.CAN-16-2854. Epub 2017 Mar 10.
NCCN Clinical Practical Guidelines in Oncology: Breast Cancer, Version 3.2021.Link provided by the sponsor.
Individual participant dataSharing planned: No. Because the data involves the patient's personal information, it is temporarily decided that we will not disclose the individual participant data.

Related trials for HR Positive/HER2 Low Expression Metastatic Breast Cancer

RecruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
Locally Advanced or Metastatic Breast Cancer
RecruitingPhase 2
A Phase II Study of SSGJ-612 Plus a HER2-Targeted ADC in HR-Positive, HER2-Low or HER2-Ultralow Expression Metastatic Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 2
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
Breast Cancer
RecruitingPhase 2
A Trial of Trastuzumab Rezetecan in Unresectable Locally Recurrent/Metastatic Breast Cancer
Unresectable Locally Recurrent Breast Cancer, Unresectable Locally Metastatic Breast Cancer

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.

Ying Wang contact

86-20-34070870

wangy556@mail.sysu.edu.cn

Jianli Zhao contact

86-20-34070499

zhaojli5@mail.sysu.edu.cn

Ying Wang principal investigator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: looking for participants now, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying Wang (86-20-34070870, wangy556@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: 24 months). 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 NCT05904964, which also lists 9 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 Jun 2023.