Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
Conditions
Brief summary
This is a phase II open-label, multicenter trial assessing the efficacy of combination regimenDalpiciclib plus Exemestane plus trastuzumab plus pyrotinibin 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.
Interventions
DRUGTrastuzumab Pyrotinib Exemestane Dalpiciclib
Early triple positive breast cancer patients receive combination regimen of Dalpiciclib in Combination With Exemestane and Trastuzumab plus pyrotinib
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete response (pCR) | at surgery | Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLuyan Chen, Doctor
Backup ContactLuyan Chen, Doctor
Outcome results
None listed