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RecruitingNCT05904964Updated Jun 22, 2023

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

A Phase 3 interventional study of Disitamab vedotin and Endocrine therapy in HR Positive/HER2 Low Expression Metastatic Breast Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study summary

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.

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Conditions studied

  • HR Positive/HER2 Low Expression Metastatic Breast Cancer

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Keywords

  • HR positive
  • HRE2 low expression
  • metastatic breast cancer
  • ADC
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 288 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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;
  2. 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 +);
  3. Patients who have received endocrine therapy ;
  4. 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;
  5. Patients with stable brain metastasis or asymptomatic brain metastasis;
  6. ECOG physical condition score ≤ 2 points, and the estimated survival time is not less than 3 months;
  7. 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);
  8. 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;
  9. 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;
  10. Patients understand the research process, voluntarily participate in the research, and sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. Patients who had received chemotherapy, radiotherapy, immunotherapy, and endocrine therapy for breast cancer within 2 weeks before enrollment.;
  2. Patients who had performed major surgery within 2 weeks before enrollment.
  3. 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);
  4. 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;
  5. Have a clear history of neurological or mental disorders, including epilepsy or dementia;
  6. 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.
  7. Those who have been known to have allergic history to Disitamab Vedotin or similar drugs;
  8. 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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
288 participants (estimated)

Study arms

  • Experimental
    Disitamab Vedotin

    Disitamab Vedotin, 2mg/kg, every 2 weeks

    Drug: Disitamab vedotin

  • Active comparator
    Endocrine therapy

    Doctors choose endocrine therapy independently

    Other: Endocrine therapy

Interventions

  • DrugDisitamab vedotin

    Disitamab Vedotin 2mg/kg was injected every 2 weeks,

    Also known as: RC48

  • OtherEndocrine therapy

    Doctors choose endocrine therapy independently

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What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    The interval from the date of randomization to the first imaging confirmed progression of disease or death from any cause.

    Time frame: 24 months

Secondary outcomes

  1. Overall survival (OS)

    The time interval from the date of randomization to death due to any cause.

    Time frame: 36 months

  2. 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.

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

  4. 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.

    Time frame: 12 months

  5. Quality of life assessed by EORTC-C30

    Quality of life will be collected using the following questionnaire: EORTC-C30

    Time frame: 12 months

  6. Psychological condition assessed by GAD-7

    Time frame: 12 months

  7. Pittsburgh Sleep Scale

    Time frame: 12 months

  8. 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.

    Time frame: from the date of enrollment to one year

  9. 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）

    Time frame: 12 months

07

Study locations

3 of 3 sites recruiting
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    Recruiting
  • The Second Affiliated Hospital， Shantou University Medical College
    Shantou, Guangdong 515000, China
    • Zhiyang Li · Contact
    Recruiting
  • Hainan Qionghai People's Hospital
    Qionghai, Hainan 571400, China
    • Jianbao Wang · Contact
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No — Because the data involves the patient's personal information, it is temporarily decided that we will not disclose the individual participant data.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05904964
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Responsible party
Ying Wang (Associate Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
Jun 15, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2030 (estimated)
Last update
Jun 22, 2023

Study contacts

Ying Wang
Contact
wangy556@mail.sysu.edu.cn
86-20-34070870
Jianli Zhao
Contact
zhaojli5@mail.sysu.edu.cn
86-20-34070499
Ying Wang
principal investigator · Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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