Neoadjuvant Study of Dalpiciclib in Combination With Letrozole and Trastuzumab Plus Pyrotinib in Early ER+ HER2+ Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a phase II open-label, multicenter trial. The study assesses the treatment of patients with ER-positive /HER2 positive early breast cancer with neoadjuvant Dalpiciclib in Combination With Letrozole and Trastuzumab plus pyrotinib. Patients were treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) and oral pyrotinib (400 mg po QD, Q3W) for six cycles plus oral Dalpiciclib (150 mg QD x 21 Q4W) and oral letrozole (2.5 mg po QD for 20 weeks). The primary endpoints was pathological complete response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Treatments: Letrozole; Trastuzumab

Criteria

Inclusion Criteria:

• 18 Years to 75 Years

• Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer, staging criteria is to be based on AJCC 7.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Primary tumor must have positive estrogen receptor (ER) ≥10%

• Primary tumor must be HER2-positive (IHC 3+ or FISH/CISH amplification)

• Baseline LVEF ≥50% measured by Echocardiography (preferred) or MUGA scan

• Normal organ and marrow function

• Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.

• Baseline corrected QT interval (QTcF) < 480 ms

• All patients must be female.

Exclusion Criteria:

• Inflammatory breast cancer

• Evidence of bilateral invasive breast cancer or metastatic disease

• Received any prior treatment for primary invasive breast cancer

• Pregnant or lactating women

• Abnormal baseline hematological values:

• Abnormal baseline liver function, bilirubin, creatinine and/or INR (international normalized ratio)

• Subjects with known infection with HIV, HBV, HCV

• Other investigational drugs while on study

• Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.

• Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol