Combination treatment for HR+/HER2+ breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shengjing Hospital of China Medical University
  Shenyang, Liaoning, China Recruiting

Study contacts

• Study coordinator: Nan Niu
• Email: niunannancy@163.com
• Phone: +8618940256668

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using blood ctDNA to compare two pre-surgery HER2-positive breast cancer regimens

  We will test whether two different pre-surgery drug combinations clear tumor DNA from the blood better in people with HER2-positive early breast cancer.

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• Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer

  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer

  This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07615751

• Pre-surgery trastuzumab deruxtecan (SHR-A1811) plus pertuzumab for HER2-positive breast cancer

  This trial tests giving trastuzumab deruxtecan (SHR-A1811) with pertuzumab before surgery to see if it helps women with stage II–III HER2-positive breast cancer achieve a complete response.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT07393425

• Intensified HER2-targeted treatment for people with a suboptimal response to initial dual HER2 therapy and chemotherapy

  This trial will try stronger targeted drug combinations for people with HER2-positive early breast cancer who don't respond well to initial dual HER2-targeted therapy plus chemotherapy.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou · NCT07340398

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.