Actively Recruiting
Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC
Led by Shengjing Hospital · Updated on 2022-09-13
12
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
NOAH study confirmed that trastuzumab combined with chemotherapy can significantly improve PCR compared with chemotherapy alone, and established the status of trastuzumab as a new adjuvant targeted therapy. The emergence of CDK4/6 inhibitors has brought hope to breast cancer patients resistant to endocrine therapy. studies have shown that pyrotinib maleate combined with CDK4/6 inhibitor can significantly inhibit the proliferation of HER2 positive breast cancer cell lines, reduce the activation of pAKT and pHER3, inhibit cell arrest in G0-G1 phase, and increase cell apoptosis. In the mouse model, pyrotinib maleate combined with CDK4/6 inhibitor exhibits higher anti-tumor activity than any anti-tumor drug alone. Moreover, the toxicity of the combined therapy does not increase compared with monotherapy. This provides a good preclinical model for the treatment of breast cancer by pyrotinib maleate combined with CDK4/6 inhibitor. In addition, NeoALTTO study、CALGB 40601 study、NSABP B-41 study confirmed that the clinical efficacy of lapatinib combined with trastuzumab combined chemotherapy was better than that of lapatinib or trastuzumab single target treatment group. Therefore, it is envisaged that the combination of pyrotinib maleate and dalpiciclib combined with letrozole on the basis of adding new trastuzumab to treat triple positive breast cancer will further improve the curative effect. In conclusion, we believe that pyrotinib maleate combined with trastuzumab, dalpiciclib and letrozole can provide better strategies for neoadjuvant therapy in patients with II-III three positive breast cancer.
CONDITIONS
Official Title
Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in Combination for Stage II-III TPBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years
- Women previously having ovariectomy, or aged 60 years or older
- Women under 60 years with 12 consecutive months of amenorrhea and postmenopausal hormone levels
- Premenopausal or perimenopausal women willing to receive LHRH agonist treatment
- Histopathologically confirmed breast cancer positive for estrogen receptor (>10%), progesterone receptor (>1%), and HER2 according to 2018 ASCO/CAP guidelines
- Stage II-III breast cancer diagnosed by AJCC 8th edition
- Karnofsky Performance Status score of 70 or higher
- Adequate bone marrow, liver, kidney, heart function as specified
- Ability to undergo biopsy
- Willingness to provide informed consent and comply with follow-ups
You will not qualify if you...
- Prior anti-tumor treatment including chemotherapy, radiotherapy, targeted therapy, or endocrine therapy
- Concurrent use of other anti-tumor drugs
- Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer
- Stage IV breast cancer
- Breast cancer not histopathologically confirmed
- Other malignant tumors within past 5 years except healed cervical carcinoma in situ
- Severe dysfunction of heart, liver, kidney, or other major organs
- Conditions affecting drug administration or absorption such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Participation in other clinical drug trials within past 4 weeks
- Known allergy to study drugs or history of immunodeficiency including HIV, hepatitis B or C, or organ transplantation
- History of significant heart diseases including arrhythmia needing treatment, myocardial infarction, or heart failure
- Pregnant or lactating women, or women unwilling to use contraception
- Accompanying uncontrolled diseases that may affect health or study completion
- History of neurological or psychiatric disorders including epilepsy or dementia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110004
Actively Recruiting
Research Team
N
Nan Niu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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