Clinical trial NCT03847818: Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Chemotherapy in Patients With HER2 Positive Breast Cancer
Official title: A Prospective, Open-label,Multicenter Phase II Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Chemotherapy in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HER2-positive Breast Cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 268
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pyrotinib (400mg orally daily)+Trastuzumab (8mg/kg iv load followed by 6mg/kg iv 3-weekly)+Docetaxel (75mg/m2)+ Carboplatin(AUC=5/6), for a total of 4 cycles.
Primary purpose: TREATMENT

Brief summary: This is a prospective, open-label,multicenter Phase II study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus chemotherapy as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.

Detailed description: The investigators hypothesized that the experimental group (Pyrotinib+Trastuzumab+Docetaxel+ Carboplatin) could have a higher Pathological Complete Response (pCR) rate than the control group (Trastuzumab+Docetaxel+ Carboplatin) in neoadjuvant chemotherapy.

It is proposed that 268 participants will be enrolled in this study. The target population is women with early breast cancer (stage of T2-3N0-3M0) who are eligible for primary systemic therapy.

The primary objective of the trial is to determine the pCR rate. The secondary objective of the trial is to determine the Event-free survival(EFS), Disease-free Survival (DFS), Distance Disease-free Survival (DDFS), Objective Response Rate (ORR) rate.

Eligibility criteria: Inclusion Criteria:

1. female patients, 18 years ≤ age ≤75 years；
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;
3. Histologically confirmed invasive breast cancer（early stage or locally advanced）
4. HER2 positive (HER2+++ by IHC or FISH+)
5. Known hormone receptor status.
6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
7. Signed informed consent form (ICF)

Exclusion Criteria:

1. Metastatic disease (Stage IV) or inflammatory breast cancer.
2. Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
3. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
4. Unable or unwilling to swallow tablets.

Primary outcomes:
measure: Percentage of Participants With Pathological Complete Response (pCR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Event-free survival
timeFrame: Following surgery until Year 3
measure: Disease-free Survival
timeFrame: Following surgery until Year 3
measure: Distance Disease-free Survival
timeFrame: Following surgery until Year 3
measure: Objective Response Rate
timeFrame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery) up to approximately 12 months
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Shandong University
name: Yu Zhigang, DR.
role: PRINCIPAL_INVESTIGATOR
References: