Overview

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