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Trial Title:
Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer
NCT ID:
NCT05638594
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Carboplatin
Docetaxel
Trastuzumab
Letrozole
Pertuzumab
Hormones
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
320mg, qd
Arm group label:
Pyrotinib +trastuzumab+dalpiciclib+letrozole
Intervention type:
Drug
Intervention name:
Trastuzumab
Description:
8 mg/kg first dose, then 6 mg/kg，q3w
Arm group label:
Pyrotinib +trastuzumab+dalpiciclib+letrozole
Arm group label:
Trastuzumab + pertuzumab + docetaxel + carboplatin
Other name:
Herceptin
Intervention type:
Drug
Intervention name:
Dalpiciclib
Description:
125mg , qd，d1-21, q4w
Arm group label:
Pyrotinib +trastuzumab+dalpiciclib+letrozole
Intervention type:
Drug
Intervention name:
Letrozole
Description:
2.5mg，qd
Arm group label:
Pyrotinib +trastuzumab+dalpiciclib+letrozole
Intervention type:
Drug
Intervention name:
Pertuzumab
Description:
840 mg first dose, then 420 mg, q3w
Arm group label:
Trastuzumab + pertuzumab + docetaxel + carboplatin
Other name:
Perjeta
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
75 mg/m2, q3w
Arm group label:
Trastuzumab + pertuzumab + docetaxel + carboplatin
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
AUC 6, q3w
Arm group label:
Trastuzumab + pertuzumab + docetaxel + carboplatin
Intervention type:
Drug
Intervention name:
Gonadotropin-releasing hormone agonist
Description:
Every 4 weeks for 5 cycles, premenopausal patients only
Arm group label:
Pyrotinib +trastuzumab+dalpiciclib+letrozole
Summary:
This is an investigator-initiated randomized controlled, open-label, multicenter,
prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer
were randomly divided into two groups at a ratio of 1:1. The experimental group received
pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group
received trastuzumab combined with pertuzumab, docetaxel and carboplatin. The main study
objective was to evaluate the efficacy and safety of neoadjuvant therapy for HR +/HER2 +
breast cancer in the two groups.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients aged 18 -75 ;
2. Willing to receive LHRH agonist therapy (premenopausal patients only);
3. All patients were histopathologically confirmed to be estrogen receptor (ER)
-positive and HER2-positive.
4. Treatment-naïve stage II-III patients with tumor stage meeting AJCC version 8
criteria;
5. ECOG score 0-1;
6. Organ function level must meet the following requirements:
(1) bone marrow function • ANC ≥ 1.5 x 109/L ; • PLT ≥ 100 × 109/L • Hb ≥ 90 g/L ; (2)
hepatic and renal function • TBIL ≤ 1.5 × ULN; • AL and AST ≤ 3 × ULN (ALT and AST ≤ 5 ×
ULN in patients with liver metastases); • BUN and Cr ≤ 1.5 × ULN and creatinine clearance
≥ 50 mL/min; (Cockcroft-Gault formula) (3) Echocardiography: LVEF ≥ 50%; (4) 12-lead ECG:
QT interval ≤ 480 ms; 7. Able to undergo needle biopsy; 8. Voluntarily join this study to
sign informed consent, have good compliance and willing to cooperate with follow-up.
Exclusion Criteria:
1. Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular
targeted therapy, endocrine therapy, etc.);
2. Received any other anti-tumor therapy at the same time;
3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer;
4. Stage IV breast cancer;
5. Breast cancer without histopathological diagnosis;
6. Other malignant tumors in the past 5 years, except cured cutaneous basal cell
carcinoma and cervical carcinoma in situ;
7. Severe heart, liver and kidney and other vital organ dysfunction;
8. Inability to swallow, chronic diarrhea and intestinal obstruction, there are a
variety of factors affecting drug administration and absorption;
9. Participated in other drug clinical trials within 4 weeks before enrollment;
10. Known history of hypersensitivity to the drug components of this protocol; history
of immunodeficiency, including positive HIV test, HCV, active viral hepatitis B or
other acquired, congenital immunodeficiency diseases, or history of organ
transplantation;
11. Had any cardiac disease, including: (1) cardiac arrhythmia requiring medication or
clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other
cardiac disease judged by the investigator to be inappropriate for participation in
this trial;
12. Female patients who are pregnant or lactating, female patients of childbearing
potential with a positive baseline pregnancy test, or female patients of
childbearing age who are unwilling to take effective contraceptive measures
throughout the trial;
13. According to the investigator 's judgment, there are concomitant diseases that
seriously jeopardize the patient' s safety or affect the patient 's completion of
the study (including but not limited to uncontrolled severe hypertension, severe
diabetes, active infection, etc.);
14. Had a documented history of neurological or psychiatric disorders, including
epilepsy or dementia.Any other condition that, in the opinion of the investigator,
would make the patient inappropriate for participation in this study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Recruiting
Contact:
Last name:
Cai-Gang Liu, PHD
Phone:
+86 18940254967
Email:
liucg@sj-hospital.org
Investigator:
Last name:
Cai-Gang Liu, PHD
Email:
Principal Investigator
Start date:
December 20, 2022
Completion date:
December 10, 2027
Lead sponsor:
Agency:
Shengjing Hospital
Agency class:
Other
Source:
Shengjing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05638594
