Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer

• ClinicalTrials.gov Identifier: NCT03588091
• Recruitment Status: Unknown
• First Posted: July 17, 2018
• Last Update Posted: August 4, 2021
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Tracking Information

• First Submitted Date: June 18, 2018
• First Posted Date: July 17, 2018
• Last Update Posted Date: August 4, 2021
• Actual Study Start Date: July 24, 2018
• Actual Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 3, 2018): Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC) [ Time Frame: through study completion, an average of 1 year ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 3, 2018)

• Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites [ Time Frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days) ]
• Event-free survival(EFS) [ Time Frame: Following surgery until Year 3 ]
• Disease-free Survival (DFS) [ Time Frame: Following surgery until Year 3 ]
• Distance Disease-free Survival (DDFS) [ Time Frame: Following surgery until Year 3 ]
• Objective Response Rate (ORR) during neoadjuvant period [ Time Frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
• Official Title: A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
• Brief Summary: This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: HER2-positive Breast Cancer

Intervention

• Drug: Pyrotinib
  pyrotinib: 400mg orally daily;
• Drug: Placebo Oral Tablet
  placebo: 400mg orally daily;
• Drug: Trastuzumab
  trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
• Drug: Docetaxel
  docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles

Study Arms

• Experimental: arm1
  Pyrotinib Plus trastuzumab and docetaxel
  Interventions:

  • Drug: Pyrotinib
  • Drug: Trastuzumab
  • Drug: Docetaxel
• Placebo Comparator: arm2
  placebo plus trastuzumab and docetaxel
  Interventions:

  • Drug: Placebo Oral Tablet
  • Drug: Trastuzumab
  • Drug: Docetaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: August 3, 2021): 355
• Original Estimated Enrollment (submitted: July 3, 2018): 294
• Estimated Study Completion Date: June 2022
• Actual Primary Completion Date: April 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• metastatic disease (Stage IV) or inflammatory breast cancer
• 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.
• clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
• Unable or unwilling to swallow tablets.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03588091
• Other Study ID Numbers: HR-BLTN-III-NeoBC
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jiangsu HengRui Medicine Co., Ltd.
• Verification Date: August 2021