At a glance
ClinicalIndex Comparison Record- ✓Women aged 18-75 years
- ✓Postmenopausal status: prior ovariectomy, age ≥60, or 12 months amenorrhea with postmenopausal hormone levels
- ✓Premenopausal/perimenopausal women willing to receive LHRH agonist
- ✓Histologically confirmed ER+ (>10%), PR+ (>1%) breast cancer by IHC
- ✕Prior anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
- ✕Concurrent anti-tumor drug treatments
- ✕Bilateral, inflammatory, or occult breast cancer
- ✕Stage IV (metastatic) breast cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05228951Phase 2RecruitingUpdate OverdueUpdated 45mo ago · Completion was 42mo agoPyrotinib Maleate, Trastuzumab, SHR6390(Dalpiciclib) and Letrozole in Combination for Neoadjuvant Treatment of Stage II-III TPBC
In Brief
A Phase 2 clinical trial evaluating Pyrotinib maleate, dalpiciclib, Trastuzumab, letrozole for Breast Cancer. Currently recruiting, targeting 12 participants across 1 site.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
After providing written informed consent, the participants will undergo combined treatment of pyrotinib maleate, CDK4/6 inhibitor dalpiciclib, trastuzumab and letrozole. The effectiveness of the combined treatment will be evaluated by MRI every two treatment cycles. If the disease progresses, the participant will withdraw from the trial. If the combined treatment has identified effectiveness, the participant will undergo surgical treatment within 4 weeks (over 2 weeks) after termination of the neoadjuvant treatment. The patients will be followed up for 5 years.