Trial Title:
The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study
NCT ID:
NCT06254690
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Docetaxel
Trastuzumab
Conditions: Keywords:
HER2 positive
Pyrotinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pyrotinib dose escalation
Description:
Pyrotinib: 240mg in the first week, 320mg in the second week, and 400mg in the third week
and thereafter, by mouth(po),once a day(qd) Trastuzumab: 8mg/Kg in the first cycle,
6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel:
75mg/m2，intravenous(iv), every 3 weeks(q3w)
Arm group label:
Pyrotinib dose escalation group
Other name:
Trastuzumab
Other name:
Docetaxel
Intervention type:
Drug
Intervention name:
Pyrotinib dose normal
Description:
Pyrotinib: 400mg per week, by mouth(po),once a day(qd) Trastuzumab: 8mg/Kg in the first
cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel:
75mg/m2，intravenous(iv), every 3 weeks(q3w)
Arm group label:
Pyrotinib dose normal group
Other name:
Trastuzumab
Other name:
Docetaxel
Summary:
Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to
normal-dose regimen for HER2-positive advanced first-line breast cancer
Detailed description:
This study is planned to include 102 patients with HER2-positive advanced breast cancer
meeting the admission criteria between 2023-12-01 and 2024-11-01. Statistical software
will be used by the randomization officers for 1:1 allocation to pyrotinib dose
increasing trial group and normal pyrotinib dose control group .
The primary endpoint of this study was grade ≥3 treatment-emergent diarrhea incidence
during the first 2 cycles according to Common Terminology Criteria for Adverse Events,
version 5.0, and secondary endpoints were adverse effects of pyrotinib during the study,
efficacy (progression-free survival and overall survival), and patient-reported outcome.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The subjects voluntarily joins the study and signs the informed consent;
2. Subject is an adult female ≥ 18 years old and ≤ 70 years old at the time of informed
consent.
3. HER2-positive advanced breast cancer confirmed by pathology (HER2-positive
expression refers to those with at least one tumor cell immunohistochemical staining
intensity of 3+ or 2+ positive by fluorescence in situ hybridization [FISH] in the
pathological examination/review of the primary or metastatic lesion conducted by the
pathology department of the Central Hospital)
4. Stage IV breast cancer according to American Joint Committee on Cancer(AJCC) staging
system version 8.
5. Subjects did not receive systemic antitumor therapy at the stage of
recurrence/metastasis;
6. At least one measurable lesion according to Response Evaluation Criteria In Solid
Tumors version 1.1 criteria
7. When randomized, Eastern Cooperative Oncology Group(ECGO) physical fitness status is
0 or 1 point.
8. Vital organ function meets the following requirements (excluding the use of any
blood components and cell growth factors during screening) : Absolute neutrophil
(ANC) count ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥9g/dL; Serum
albumin ≥3g/dL; Thyroid stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4
levels should be investigated at the same time, if T3 and T4 levels are normal, they
can be included in the group); Bilirubin ≤1.5 ULN; Alanine aminotransferase (ALT)
and aspartate aminotransferase (AST) ≤2.5 times ULN; Alkaline phosphatase (AKP) ≤
2.5 times ULN; Serum creatinine (Cr) ≤1.5 times ULN or creatinine clearance
≥60mL/min.
Exclusion Criteria:
1. Any previous tyrosine kinase inhibitor therapy against HER2 target;
2. Patients with known active central nervous system metastases without surgery or
radiation therapy, except those who have been stable for at least 1 month after
treatment and have been off corticosteroids for >2 weeks;
3. Pial metastasis confirmed by MRI or lumbar puncture;
4. Inflammatory breast cancer or other malignancies within the previous 5 years,
excluding cured basal cell carcinoma of the skin and carcinoma in situ of the
cervix;
5. Any antitumor therapy within 4 weeks prior to enrollment;
6. Pregnant or breastfeeding women (women of childbearing age must have a negative
pregnancy test within 14 days prior to the first dose, if positive, the pregnancy
must be ruled out by ultrasound);
7. Patients with gastrointestinal insufficiency or gastrointestinal disease
significantly affecting the absorption of the investigational drug (e.g.,
uncontrolled ulcerative disease, uncontrolled nausea, vomiting, diarrhea,
malabsorption syndrome, or resection of the small intestine);
8. Patients with ascites, pleural effusion and pericardial effusion accompanied by
clinical symptoms requiring drainage at baseline, or patients with serosal effusion
drainage within 4 weeks before the first medication;
9. Patients with a history of immunodeficiency, including HIV testing positive, other
acquired or congenital immunodeficiency diseases, or a history of organ
transplantation;
10. Patients with a major surgical procedure or significant trauma within 4 weeks before
starting treatment, or expected to undergo major surgery;
11. Concomitant medical conditions (e.g., severe hypertension, diabetes, thyroid
disease, co-active hepatitis B/C, and other active infections, etc.) that are deemed
by the investigator to seriously endanger the patient's safety or to interfere with
the patient's completion of the study;
12. Inability to understand or follow research instructions and requirements;
13. The investigator considers the patient unsuitable for entry into this study.
Gender:
Female
Gender based:
Yes
Gender description:
Patient is an adult female ≥ 18 years old and ≤ 70 years old at the time of informed
consent.
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongmei Yin
Start date:
January 1, 2024
Completion date:
December 1, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Collaborator:
Agency:
Zhongda Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Collaborator:
Agency:
Jingjiang People's Hospital
Agency class:
Other
Collaborator:
Agency:
Yancheng First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Jiangnan University
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Huai'an First People's Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Xuzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Suzhou Municipal Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Jiangsu University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06254690
