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

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03588091
Collaborator
(none)
355
Enrollment
17
Locations
2
Arms
46.3
Anticipated Duration (Months)
20.9
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
355 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 24, 2018
Actual Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: arm1

Pyrotinib Plus trastuzumab and docetaxel

Drug: Pyrotinib
pyrotinib: 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
Placebo Comparator: arm2

placebo plus trastuzumab and docetaxel

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

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC) [through study completion, an average of 1 year]

Secondary Outcome Measures

  1. Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites [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)]

  2. Event-free survival(EFS) [Following surgery until Year 3]

  3. Disease-free Survival (DFS) [Following surgery until Year 3]

  4. Distance Disease-free Survival (DDFS) [Following surgery until Year 3]

  5. Objective Response Rate (ORR) during neoadjuvant period [Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University People's Hospital Beijing Beijing China 100044
2 The Fifth Medical Center of Chinese PLA General Hospital Beijing Beijing China 100071
3 Fujian Medical University Union Hospital Fuzhou Fujian China 350001
4 Sun Yet-Sen University Cancer Center Guangzhou Guangdong China 510010
5 Guangdong Provincial People's Hospital Guangzhou Guangdong China 510080
6 Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong China 510289
7 The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei China 050000
8 The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital Zhengzhou Henan China 450000
9 Huai'an First People's Hospital Huaian Jiangsu China 223001
10 JiangSu Province Hospital Nanjing Jiangsu China 210029
11 Shandong Cancer Hospital Jinan Shandong China 250000
12 The Affiliated Hospital Of Qingdao University Qingdao Shandong China 266100
13 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032
14 The Second Affiliated Hospital Of Xi'an Jiaotong University Xian Shanxi China 710004
15 The First Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China 310003
16 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310005
17 The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China 310009

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03588091
Other Study ID Numbers:
  • HR-BLTN-III-NeoBC
First Posted:
Jul 17, 2018
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Docetaxel
Trastuzumab

Study Results

No Results Posted as of Aug 4, 2021