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Breast CancerPhase 3NCT05755048

FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

A Phase 3 study testing Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502) in people with Breast Cancer, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 56 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with trastuzumab and taxane. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
314 participants
Where
56 sitesChina
Study dates
28 Mar 2023to 31 Jan 2026
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patients that meet any of the following conditions shall not be included in this clinical study:
  • Patients who have received chemotherapy, small molecule targeted drug therapy, endocrinotherapy，radiotherapy, etc. within 14 days or 5 half-lives (whichever is shorter) before administration or who have received major surgical treatment and tumor immunotherapy within 4 weeks before administration or who have received large molecule monoclonal antibody drugs for cancer treatment within 21 days before administration.
  • Patients who have participated in other clinical studies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before administration.
  • Patients who have been previously treated with anti-HER2 ADCs for metastatic diseases.
  • Patients with known hypersensitivity or delayed type hypersensitivity to certain ingredients of T-DM1 or similar drugs, or with known contraindications for the use of T-DM1.
  • Patients with pia maters, spinal cords, brainstem and brain parenchymal metastases; such patients are allowed to be enrolled if all of the following conditions are met:
Show all 24Show fewer
  • Patients who have received local treatment and the lesions are stable for more than 6 months;
  • Patients who have no clinical symptoms and don't need glucocorticoid therapy or other dehydration treatment, and have a stable dose of an antiepileptic drug, if applicable.
  • Patients with a large quantity of clinically uncontrolled pleural effusion, pericardial effusion, or ascites (within 2 weeks prior to the first dose).
  • Unresolved toxic reactions from previous anti-tumor therapy (> NCI-CTCAE 5.0 Grade 1); however, alopecia, neurotoxicity or other toxicity that has converted to chronic and returned to NCI-CTCAE 5.0 Grade ≤ 2, and does not affect the safety of the patient as assessed by the Investigator are allowed to be enrolled.
  • History of non-infectious interstitial lung disease (ILD) / pneumonia, current ILD / pneumonia, or imaging suggestive of suspected moderate-severe ILD / pneumonia at screening.
  • Subjects with corneal epithelial lesions (except mild punctate keratopathy), or other ocular diseases that affect the evaluation of ocular toxicity after the investigational product administration, or unwilling to stop wearing corneal contact lenses during the study.
  • Patients on medications that prolong the QTc interval (mainly Classes Ia, Ic, III anti- arrhythmia medications) or with risk factors for prolonging the QTc interval, such as uncorrectable hypokalemia, inherited long QT syndrome; potential medications for prolonging the QTc interval are presented in Appendix 7.
  • Cardiac function and diseases that meet one of the following conditions:
  • Mean QTc > 450 ms for males and mean QTc > 470 ms for females averaged from 3 results of 12-lead ECG measurements using the QTcF formula of the ECG instrument at the study site during the screening period;
  • New York Heart Association (NYHA) Functional Classification ≥ Class 2 congestive heart failure;
  • Clinically significant arrhythmia (Grade ≥ 2);
  • History of myocardial infarction or severe arteriovenous thrombotic events within 6 months.
  • Pregnant or breastfeeding women.
  • Known hypersensitivity to any excipients of FS-1502.
  • Active infection requiring systemic therapy.
  • Active hepatitis B (positive for HBV surface antigen and detected with HBV DNA > 1000 IU/mL or meeting the diagnostic criteria for active hepatitis B infection at the study site) or hepatitis C (positive for HCV RNA) and human immunodeficiency viral infection (HIV positive).
  • Any other malignancy diagnosed within 5 years prior to the study, except for early malignancies (carcinoma in situ) that have undergone radical treatment, such as adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ.
  • Any other diseases or conditions considered clinically significant by the investigator that could affect protocol compliance or affect the patient's ability to sign the ICF.

Trial locations and contacts

56 sites in 1 country.

Binghe Xu, MD contact

13501028690

xubingheBM@163.com

56 sites in 1 country

China56 sites, 56 recruiting

  • AnYang Cancer Hospital

    Anyang, Henan

    Jin Xia, MD, 15890750990, 15890750990@126.com

    Jin Xia, MD

    Recruiting

  • Affiliated Hospital of Hebei University

    Baoding, Hebei

    Hua Yang, MD, 18603120729, docyh@163.com

    Hua Yang, MD

    Recruiting

  • Chinese People's Liberation Army General Hospital fifth Medical Center South ward

    Beijing, Beijing Municipality

    Tao Wang, MD, 13910928773, wangtaodoc@163.com

    Tao Wang, MD

    Recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality

    Shu Wang, MD, 13801080201, dr.wangshu@263.net

    Shu Wang, MD

    Recruiting

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui

    Gongsheng Jin, MD, 13095520028, Jgs2007@qq.com

    Gongsheng Jin, MD

    Recruiting

  • Cangzhou Central Hospital

    Cangzhou, Hebei

    Guozhong Cui, MD, 13315777876, 916291826@qq.com

    Guozhong Cui, MD

    Recruiting

  • First Hospital of Jilin University

    Changchun, Jilin

    Jiuwei Cui, MD, 15843073215, jdyycjw@163.com

    Jiuwei Cui, MD

    Recruiting

  • Jilin Cancer Hospital

    Changchun, Jilin

    Ying Cheng, MD, 0431-80596315, jl.cheng@163.com

    Ying Cheng, MD

    Recruiting

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan

    Wenjun Yi, Doctor, 18608403318, yiwenjun@csu.edu.cn

    Wenjun Yi, Doctor

    Recruiting

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

    YanHui Liu, MD, 18980601509, 827005432@qq.com

    YanHui Liu, MD

    Recruiting

  • Chenzhou No.1 People's Hospital

    Chenzhou, Hunan

    Hailong Liu, MD, 18973575117, 827362121@qq.com

    Hailong Liu, MD

    Recruiting

  • Affiliated Cancer Hospital of Chongqing University

    Chongqing, Chongqing Municipality

    Xin Zhou, MD, 13452987363, zhouxin000017@163.com

    Xin Zhou, MD

    Recruiting

  • Chinese People's Liberation Army Army Special Medical Center

    Chongqing, Chongqing Municipality

    Jinlu Shan, MD, 18623026302, lulu@sina.com

    Jinlu Shan, MD

    Recruiting

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Ma Li, MD, 17709873580, dyeyliman@sohu.com

    Ma Li, MD

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    YueHua Wang, MD, 13995777482, 510839835@qq.com

    YueHua Wang, MD

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Xiaoyan Lin, MD, 139 5048 2366, 13950482366@qq.com

    Xiaoyan Lin, MD

    Recruiting

  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army

    Fuzhou, Fujian

    Xi Chen, MD, 13705045925, cxifuzhou@163.com

    Xi Chen, MD

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Kun Wang, MD, 13922118086, gzwangkun@126.com

    Kun Wang, MD

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Yanxia Shi, MD, 13609058827, shiyx@sysucc.org.cn

    Yanxia Shi, MD

    Recruiting

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong

    Ying Lin, MD, 130 7687 3871, frostlin@hotmail.com

    Ying Lin, MD

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Jian Huang, MD, 139 5812 3068, hjys@zju.edu.cn

    Jian Huang, MD

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Xiaojia Wang, MD, 13906500190, wxiaojia0803@163.com

    Xiaojia Wang, MD

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Qing Yuan Zhang, MD, 13313612989, ns86298333@163.com

    Qing Yuan Zhang, MD

    Recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

    Changlu Hu, MD, 13955116061, 13955116061@139.com

    Changlu Hu, MD

    Recruiting

  • Shandong First Medical University and Shandong Academy of Medical Sciences Shandong Cancer Hospital institute

    Jinan, Shandong

    Huihui Li, MD, 15553103209, 15553103209@163.com

    Huihui Li, MD

    Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong

    Changping Shan, MD, 18678766865, scp9933@163.com

    Changping Shan, MD

    Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan

    Jianyun Nie, MD, 13608815577, niejianyungcp@163.com

    Jianyun Nie, MD

    Recruiting

  • The first Hospital of lanzhou University

    Lanzhou, Gansu

    Xiaoling Ling, MD, 18693165668, lingxiaolingedu@163.com

    Xiaoling Ling, MD

    Recruiting

  • Linyi Cancer Hospital

    Linyi, Shandong

    Jingfen Wang, MD, 15963976026, 15963976026@wetrial.com

    Jingfen Wang, MD

    Recruiting

  • Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan

    Lijia He, MD, 13619042857, 908380148@qq.com

    Lijia He, MD

    Recruiting

  • Nanchang People's Hospital

    Nanchang, Jiangxi

    Wenyan Chen, MB, 18679168977, chenwenyannc2013@163.com

    Wenyan Chen, MB

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

    Jifeng Feng, MD, 13901581264, fjif@vip.sina.com

    Jifeng Feng, MD

    Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

    Yongmei Yin, MD, 13951842727, ym.yin@hotmail.com

    Yongmei Yin, MD

    Recruiting

  • Guangxi Medical Univesity Cancer Hospital

    Nanning, Guangxi

    Weimin Xie, MD, 13907861028, dd.xie@qq.com

    Weimin Xie, MD

    Recruiting

  • The First Afeliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Jincai Zhong, M.M., 13907719863, 1093301007@qq.com

    Jincai Zhong, M.M.

    Recruiting

  • Neijiang Second People's Hospital

    Neijiang, Sichuan

    Xujuan Wang, MD, 13696038558, 61132803@qq.com

    Xujuan Wang, MD

    Recruiting

  • Shantou University School of Medicine Affiliated Cancer Hospital

    Shantou, Guangdong

    De Zeng, MD, 13750418885, alexzengde@163.com

    De Zeng, MD

    Recruiting

  • Liaoning cancer hospital & institute

    Shenyang, Liaoning

    Tao Sun, MD, 13940404526, lnzlrxnsy@163.com

    Tao Sun, MD

    Not yet recruiting

  • The first hospital of china medical university

    Shenyang, Liaoning

    Yuee Teng, MD, 13591639797, tengyuee0517@163.com

    Yuee Teng, MD

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center

    Shenzhen, Guangdong

    Caiwen Du, MD, 135 5631 6023, dusumc@aliyun.com

    Caiwen Du, MD

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Yunjiang Liu, doctor, 13703297890, lyj818326@126.com

    Yunjiang Liu, doctor

    Recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

    Fuguo Tian, MD, 13934559988, 2205473988@qq.com

    Fuguo Tian, MD

    Recruiting

  • TianJin Medical university Cancer Institute & Hospital

    Tianjin, Tianjin Municipality

    Zhongsheng Tong, MD, 18622221181, 18622221181@163.COM

    Zhongsheng Tong, MD

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    OuChen Wang, MD, 13957706099, woc099@163.com

    OuChen Wang, MD

    Recruiting

  • Renmin Hospital Of Wuhan University

    Wuhan, Hubei

    Feng Yao, MD, 13667174996, yaofengrmh@163.com

    Feng Yao, MD

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    yanxia Zhao, MD, 13407192551, sophia7781@126.com

    yanxia Zhao, MD

    Recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    HaiJun Yu, MD, 13971665181, doctoryhj@126.com

    HaiJun Yu, MD

    Recruiting

  • The first affiliated hospital of xiamen university

    Xiamen, Fujian

    Zhong Ouyang, doctor, 18205962909, xmdxdyyyrxkoyz@163.com

    Zhong Ouyang, doctor

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi

    Jin Yang, MD, 18991232383, 1473106133@qq.com

    Jin Yang, MD

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei

    WeiWei Huang, MD, 13763893896, huangstudenth@163.com

    WeiWei Huang, MD

    Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan

    Ping Lu, MD, 18567569821, lupingdoctor@126.com

    Ping Lu, MD

    Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Tian You Tang, MB, 13775980765, tty912@163.com

    Tian You Tang, MB

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

    Xinlan Liu, MD, 13709577339, liuxinlan@csco.ac.cn

    Xinlan Liu, MD

    Recruiting

  • The Central Hospital of Yongzhou

    Yongzhou, Hunan

    Sijuan Ding, MM, 13574624257, 874663807@qq.com

    Sijuan Ding, MM

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Chuangxin Lu, MD, 15093406297, lcxin618@163.com

    Chuangxin Lu, MD

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, ZHenan

    Min Yan, dotocr, 15713857388, ym200678@126.com

    Min Yan, dotocr

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study to Compare the Efficacy and Safety of FS-1502 Versus T-DM1 in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

Read the detailed description

This study is a multicenter, open-label, randomized controlled phase III clinical study to compare the efficacy and safety of FS-1502 versus T-DM1 in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. Patients who meet the inclusion and exclusion criteria will be randomized into the test group (FS-1502) or control group (T-DM1) in a 1:1 ratio. Patients in the test group will receive FS-1502 2.3 mg/kg, and those in the control group will receive T-DM1 3.6 mg/kg, by intravenous drip every 3 weeks. Patients will be treated until disease progression (PD), intolerable toxicity, withdrawal of consent, death, or other protocol-specified reasons. According to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1), tumor assessment will be performed every 6 weeks (± 7 days) for the first 12 months and every 12 weeks (± 7 days) after 12 months until PD, withdrawal of consent, or death. Efficacy evaluation will be performed by the investigator and the Independent Review Committee (IRC), respectively.

Conditions
Breast Cancer
Being tested
Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502), Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502)Biological

    Experimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.

  • Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)Biological

    Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla Dosage form: lyophilized powder Specification: 100 mg/vial Dose: 3.6 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip (this drug has been approved for marketing. Please refer to the package insert for details).

Study groups in NCT05755048
Study groupRoleWhat they receive
FS-1502ExperimentalExperimental: FS-1502 Dosage form: lyophilized powder Specification: 30 mg/vial Dose: 2.3 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip.
Receives: Biological: Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502)
Trastuzumab Emtansine (T-DM1)Active comparatorActive Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla Dosage form: lyophilized powder Specification: 100 mg/vial Dose: 3.6 mg/kg, once every 3 weeks, 21 days as a cycle; Method of administration: intravenous drip (this drug has been approved for marketing. Please refer to the package insert for details).
Receives: Biological: Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)

What is being measured

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

  1. Progression-Free Survival (PFS) Based on Independent Central Review (ICR) in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.

    Progression-free survival (PFS) by ICR was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: Up to 28 months.

Secondary outcomes (7)

  1. Overall Survival (OS) in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.

    Overall survival (OS) was defined as the time from the date of first dose of study drug to the date of death due to any cause.

    Measured: Up to 28 months.

  2. Objective Response Rate (ORR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.

    Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by ICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR is reported.

    Measured: Up to 28 months.

  3. Disease control rate (DCR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.

    DCR confirmed by IRC or investigator evaluation is defined as the proportion of patients with objective remission (CR or PR) or stable disease (SD) confirmed by IRC or investigator.

    Measured: Up to 28 months.

  4. Clinical benefit rate (CBR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.

    CBR confirmed by IRC or investigator evaluation is defined as the proportion of patients with confirmed CR, PR and SD lasting ≥ 24 weeks evaluated by IRC or investigator according to RECIST version 1.1.

    Measured: Up to 28 months.

  5. Duration of overall response (DOR) Based on ICR and Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.

    Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DOR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.

    Measured: Up to 28 months.

  6. Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane.

    Progression-free survival (PFS) by investigator assessment was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

    Measured: Up to 28 months.

  7. Treatment-emergent adverse events (TEAEs).

    Type and frequency of treatment-emergent adverse events (TEAEs) with toxicity grades evaluated according to the National Cancer Institute-Common Toxicity Criteria Adverse Event (NCI-CTCAE) version 5.0.

    Measured: Up to 28 months.

Timeline

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

  1. First posted6 Mar 2023
  2. Study start28 Mar 2023
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
314 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755048
Sponsor's protocol ID
FS-1502-III1-01
Status last verified
Feb 2023
First submitted
13 Feb 2023
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502) in people with Breast Cancer, run by Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. at 56 sites 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 0 inclusion and 24 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 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?

Results are not available in the source record.

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

Contact Binghe Xu, MD (13501028690, xubingheBM@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) Based on Independent Central Review (ICR) in Participants With HER2-Positive, Unresectable locally advanced or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane. (time frame: Up to 28 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 NCT05755048.

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 1 Sep 2023.

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