Clinical trial NCT04997798: Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
Official title: Phase II Open-label, Multicentre, Exploratory Trial of Neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Estrogen Receptor Positive Tumor
HER2-positive Breast Cancer
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: pathological complete response (pCR)
timeFrame: at surgery
Secondary outcomes:
measure: Serial measures of Ki67
timeFrame: baseline before therapy, 2 weeks after and at surgery
measure: Objective response
timeFrame: 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
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Peifen Fu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: