Combination treatment for HR+/HER2+ breast cancer

A Randomized Controlled, Open-label, Multicenter Clinical Study of Pyrotinib Maleate Combined With Trastuzumab,Dalpiciclib, and Letrozole Versus Trastuzumab Combined With Pertuzumab, Docetaxel, and Carboplatin as Neoadjuvant Therapy for Stage II-III HR +/HER2 + Breast Cancer

This study is testing a new combination treatment for patients with stage II-III HR+/HER2+ breast cancer to see if it works better than the standard treatment before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 236 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shengjing Hospital (Academic / other)
• Drugs / interventions: chemotherapy, trastuzumab, pertuzumab, pyrotinib
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT05638594 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of a new combination therapy for patients with stage II-III HR+/HER2+ breast cancer. Participants are randomly assigned to receive either an experimental treatment of pyrotinib, trastuzumab, dalpiciclib, and letrozole or a control treatment of trastuzumab, pertuzumab, docetaxel, and carboplatin. The study aims to determine which regimen is more effective as a neoadjuvant therapy before surgery. It is a multicenter, open-label, Phase 2 trial designed to provide insights into treatment options for this specific breast cancer subtype.

Who should consider this trial

Good fit: Ideal candidates include female patients aged 18-75 with treatment-naïve stage II-III HR+/HER2+ breast cancer.

Not a fit: Patients who have previously received anti-tumor therapy or do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective neoadjuvant treatment option for patients with HR+/HER2+ breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating HR+/HER2+ breast cancer, indicating potential for success.

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.

Where this trial is running

Shenyang, Liaoning

• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Study coordinator: Nan Niu

Conditions Breast Cancer