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

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ClinicalTrials.gov Identifier: NCT03588091
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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
HER2-positive Breast Cancer Drug: Pyrotinib Drug: Placebo Oral Tablet Drug: Trastuzumab Drug: Docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. Event-free survival(EFS) [ Time Frame: Following surgery until Year 3 ]
  3. Disease-free Survival (DFS) [ Time Frame: Following surgery until Year 3 ]
  4. Distance Disease-free Survival (DDFS) [ Time Frame: Following surgery until Year 3 ]
  5. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588091


Locations
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China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Jiong Wu, Dr.    +86-13601637369    wujiong1122@vip.sina.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03588091     History of Changes
Other Study ID Numbers: HR-BLTN-III-NeoBC
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological