Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
- Conditions
- HER2-positive Breast CancerBreast CancerEstrogen Receptor Positive Tumor
- Interventions
- Registration Number
- NCT04997798
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- Brief Summary
This is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.
- Detailed Description
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 Exemestane and Trastuzumab plus Pyrotinib. Patients were treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks. The primary endpoints was pathological complete response.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dalpiciclib in combination with exemestane and trastuzumab plus pyrotinib Trastuzumab Pyrotinib Exemestane Dalpiciclib Patients are treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks.
- Primary Outcome Measures
Name Time Method pathological complete response (pCR) at surgery Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery
- Secondary Outcome Measures
Name Time Method Serial measures of Ki67 baseline before therapy, 2 weeks after and at surgery Changes in Ki67 scores from baseline before therapy, 2 weeks after and then at surgery
Objective response Tumour assessments will be performed by ultrasound and mammography at screening (prior to start of treatment), and before surgery, an expected average of 24 weeks Defined as the number of patients with partial or complete response according to RECIST 1.1
Trial Locations
- Locations (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China