A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
NCT ID: NCT06470347
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
67 participants
INTERVENTIONAL
2022-11-01
2025-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary Study Objective:
To evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of HER-2-positive early or locally advanced breast cancer after adjuvant therapy with trastuzumab
Secondary Research Objectives:
To evaluate the safety of pyrrolitinib maleate tablets in the treatment of HER-2 positive early or locally advanced breast cancer after trastuzumab adjuvant therapy
Study Endpoints Primary Study Endpoint:
Invasive disease free survival (iDFS)
Secondary Study Endpoints:
1. overall survival (OS);
2. disease-free survival (DFS);
3. distant metastasis free survival (DDFS);
4. safety Study Population: Patients with early or locally advanced HER-2 positive breast cancer with clinical stage 0-III who have received prior neoadjuvant or adjuvant therapy. where the neoadjuvant and/or adjuvant treatment phase has been completed at least ≥24 weeks (8 dosing cycles) of trastuzumab therapy and the time interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year Study Design: Single-arm, multicenter, interventional study Administration Pyrrolitinib: The recommended dose of this product is 400 mg orally once daily within 30 minutes after breakfast for 52 weeks (approximately one year).
Dose adjustments may be made in accordance with this protocol, taking into account adverse reactions in subjects. Each consecutive suspension of piretinib during the course of the study should not exceed 14 days, prophylactic use of medications for the treatment of diarrhea is permitted during the course of treatment, multiple suspensions of study medication due to adverse events are permitted, and doses of piretinib that are missed for any reason will not be made up.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer
NCT04152057
Pyrotinib in Breast Cancer Patients With Poor Response to the Neoadjuvant Treatment of Trastuzumab and Pertuzumab
NCT04255056
The Real World Study of Pyrotinib in the Treatment of Advanced Breast Cancer With HER2 Positive
NCT06495541
Single-arm, Multi-center Clinical Study of Pyrotinib Maleate Tablets Combined With Albumin-bound Paclitaxel and Trastuzumab in Neoadjuvant Treatment of Her2-positive Early or Locally Advanced Breast Cancer
NCT04917900
Pyrotinib Combined With Trastuzumab Subcutaneously Compared Intravenous Administration in the Treatment of HER2-positive Early Breast Cancer
NCT06537674
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pyrrolitinib
Subjects will receive 52 weeks (approximately 1 year) of continuous oral administration of piretinib, 400 mg administered once daily, within 30 minutes of breakfast.
A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
During treatment, subjects were given 400 mg pyrrotinib once daily, within 30 minutes after breakfast.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy
During treatment, subjects were given 400 mg pyrrotinib once daily, within 30 minutes after breakfast.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Invasive breast cancer with clinical stage 0-III and treated surgically;
* Histopathologically confirmed HER-2 positivity: immunohistochemistry (IHC) result of 3+ or in situ hybridization (ISH) result of HER-2 gene amplification (HER-2/CEP17 ≥ 2.0 or average HER-2 copy number/cell ≥ 6);
* Have undergone radical mastectomy or breast-conserving surgery for breast cancer, with no cancer left in the body and no recurrence of metastatic disease after surgery:
1. Pathologic test confirms that there is no residual invasive cancer at the margins and no residual ductal carcinoma in situ;
2. Patients who have not received neoadjuvant therapy should have negative surgical margins, and there is no requirement for the presence of lymph node metastasis (including the presence of lymph node micrometastasis) suggested by postoperative pathological tests;
3. Patients receiving neoadjuvant therapy are not allowed to have postoperative pathologic evidence of invasive carcinoma in the breast or axillary lymph nodes;
* Previous trastuzumab anti-HER-2 therapy: completion of ≥24 weeks (8 dosing cycles) of trastuzumab in the neoadjuvant and/or adjuvant phases; the interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year.
* Known hormone receptor status (ER/PR);
* ECOG score of 0-1;
Normal function of major organs:
1. Blood count:
Neutrophils (ANC) ≥ 1.5 x 109/L; Platelet count (PLT) ≥90×109/L; Hemoglobin (Hb) ≥90 g/L;
2. Blood biochemistry:
Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; Alkaline phosphatase ≤ 2.5 x ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN;
3. Cardiac ultrasound:
Left ventricular ejection fraction (LVEF) ≥55%;
4. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \< 470 msec.
* For female patients who are not menopausal or surgically sterilized: consent to abstinence or use of an effective non-hormonal pharmacologic method of contraception for the duration of treatment and for 8 weeks after the last dose of study treatment;
* Benefit in the opinion of the investigator;
* Voluntarily participate in the study by signing an informed consent form.
Exclusion Criteria
* Prior anti-HER-2 therapy with pyrrolitinib, lenatinib, lapatinib and other tyrosine kinase inhibitors;
* History of gastrointestinal disease with diarrhea as the primary symptom;
* Psychiatric illness or psychotropic substance abuse that prevents cooperation;
* Female patients who are pregnant or breastfeeding;
* Those who, in the opinion of the investigator, are not suitable for enrollment.
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zunyi Medical College
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
LV Junyuan, Doctor of Medicine
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987 Jan 9;235(4785):177-82. doi: 10.1126/science.3798106.
Paik S, Hazan R, Fisher ER, Sass RE, Fisher B, Redmond C, Schlessinger J, Lippman ME, King CR. Pathologic findings from the National Surgical Adjuvant Breast and Bowel Project: prognostic significance of erbB-2 protein overexpression in primary breast cancer. J Clin Oncol. 1990 Jan;8(1):103-12. doi: 10.1200/JCO.1990.8.1.103.
Cossetti RJ, Tyldesley SK, Speers CH, Zheng Y, Gelmon KA. Comparison of breast cancer recurrence and outcome patterns between patients treated from 1986 to 1992 and from 2004 to 2008. J Clin Oncol. 2015 Jan 1;33(1):65-73. doi: 10.1200/JCO.2014.57.2461. Epub 2014 Nov 24.
Michaelson JS, Silverstein M, Sgroi D, Cheongsiatmoy JA, Taghian A, Powell S, Hughes K, Comegno A, Tanabe KK, Smith B. The effect of tumor size and lymph node status on breast carcinoma lethality. Cancer. 2003 Nov 15;98(10):2133-43. doi: 10.1002/cncr.11765.
Voduc KD, Cheang MC, Tyldesley S, Gelmon K, Nielsen TO, Kennecke H. Breast cancer subtypes and the risk of local and regional relapse. J Clin Oncol. 2010 Apr 1;28(10):1684-91. doi: 10.1200/JCO.2009.24.9284. Epub 2010 Mar 1.
Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Kohne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21;382(9897):1021-8. doi: 10.1016/S0140-6736(13)61094-6. Epub 2013 Jul 18.
Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Chia SKL, Mansi J, Barrios CH, Gnant M, Tomasevic Z, Denduluri N, Separovic R, Gokmen E, Bashford A, Ruiz Borrego M, Kim SB, Jakobsen EH, Ciceniene A, Inoue K, Overkamp F, Heijns JB, Armstrong AC, Link JS, Joy AA, Bryce R, Wong A, Moran S, Yao B, Xu F, Auerbach A, Buyse M, Chan A; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1688-1700. doi: 10.1016/S1470-2045(17)30717-9. Epub 2017 Nov 13.
Ma F, Li Q, Chen S, Zhu W, Fan Y, Wang J, Luo Y, Xing P, Lan B, Li M, Yi Z, Cai R, Yuan P, Zhang P, Li Q, Xu B. Phase I Study and Biomarker Analysis of Pyrotinib, a Novel Irreversible Pan-ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2017 Sep 20;35(27):3105-3112. doi: 10.1200/JCO.2016.69.6179. Epub 2017 May 12.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZMU-BRCA-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.