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 : Unknown
Verified August 2021 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was: Active, not recruiting
First Posted : July 17, 2018
Last Update Posted : August 4, 2021
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Condition or disease | Intervention/treatment | Phase |
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HER2-positive Breast Cancer | Drug: Pyrotinib Drug: Placebo Oral Tablet Drug: Trastuzumab Drug: Docetaxel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | July 24, 2018 |
Actual Primary Completion Date : | April 30, 2021 |
Estimated Study Completion Date : | June 2022 |
Arm | Intervention/treatment |
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Experimental: arm1
Pyrotinib Plus trastuzumab and docetaxel
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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
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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 |
- 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 ]
- 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 ]
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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 |
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.
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
Responsible Party: | Jiangsu HengRui Medicine Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03588091 |
Other Study ID Numbers: |
HR-BLTN-III-NeoBC |
First Posted: | July 17, 2018 Key Record Dates |
Last Update Posted: | August 4, 2021 |
Last Verified: | August 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |