Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT03084939
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
351 participants
INTERVENTIONAL
2017-04-24
2023-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trastuzumab Emtansine
Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with trastuzumab emtansine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
Trastuzumab Emtansine
Trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) was administered intravenously on Day 1 of each 21-day cycle.
Control (lapatinib + capecitabine)
Participants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with lapatinib plus capecitabine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
Lapatinib
Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
Capecitabine
Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.
Interventions
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Trastuzumab Emtansine
Trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) was administered intravenously on Day 1 of each 21-day cycle.
Lapatinib
Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
Capecitabine
Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prospective centrally assessed HER2-positive disease (i.e., immunohistochemistry \[IHC\] 3+ and/or gene amplified \[HER2 to Chromosome 17 \[CEP 17\] ratio \>/= 2\]) by in situ hybridization (ISH) through use of archival paraffin-embedded tumor tissue
* Histologically or cytologically confirmed invasive breast cancer (BC): incurable, unresectable LABC previously treated with multimodality therapy or MBC
* Prior treatment for BC in the adjuvant, unresectable locally advanced or metastatic setting must include both: a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent in the adjuvant, unresectable locally advanced or metastatic setting
* Documented progression of incurable, unresectable LABC or MBC, defined by the investigator: progression must occur during or after most recent treatment for LABC or MBC or within 6 months after completing adjuvant therapy
* Measurable and/or non-measurable disease, according the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 definition: CNS-only disease excluded
* Left ventricular ejection fraction (LVEF) \>/=50% by either echocardiogram or multiple-gated acquisition
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Adequate organ function evidenced by laboratory results within 30 days prior to randomization
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use non-hormonal contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 7 months after the last dose of study drug
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures (use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year) and agreement to refrain from donating sperm during the treatment period and for at least 7 months after the last dose of study drug
Exclusion Criteria
* Prior treatment with lapatinib or capecitabine
* Peripheral neuropathy of Grade \>/= 3 per National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0)
* History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive BC, or cancers with a similar curative outcome as those mentioned above
* History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to randomization, except hormone therapy which can be given up to 7 days prior to randomization
* History of radiation therapy within 14 days before randomization
* Brain metastases that are untreated, symptomatic, progressive, or require therapy such as radiation, surgery or corticosteroid therapy to control symptoms from brain metastases within 30 days before randomization
* History of exposure to cumulative doses of anthracyclines: Doxorubicin \> 500 milligrams per square meter (mg/m\^2), Epirubucin \> 720 mg/m\^2, Mitoxantrone \> 120 mg/m\^2
* Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
* Pregnancy or lactation
* Currently known active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
* Presence of conditions that could affect gastrointestinal absorption
* History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins
* Known hypersensitivity to 5-fluorouracil or known dihydropyrimidine dehydrogenase deficiency
* Current treatment with sorivudine or its chemically related analogs
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Beijing Hospital
Beijing, , China
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
the First Hospital of Jilin University
Changchun, , China
Jilin Cancer Hospital
Changchun, , China
Changzhou First People's Hospital
Changzhou, , China
West China Hospital, Sichuan University
Chengdu, , China
Fujian Medical University Union Hospital
Fuzhou, , China
The Second Affiliated Hospital of Zhejiang University College
Hangzhou, , China
Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangsu Province Hospital
Nanjing, , China
Jiangsu Cancer Hospital
Nanjing, , China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Liaoning cancer Hospital & Institute
Shenyang, , China
Tianjin Cancer Hospital
Tianjin, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, , China
Countries
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References
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Wang X, Li W, Yin Y, Tong Z, Zhang Q, Zheng H, Shao Z, Li H, Yang J, Feng J, Wu F, Lamour F, Restuccia E, Jiang Z. Primary results of ELAINA: a randomized, multicenter, open-label, phase III study of the efficacy and safety of trastuzumab emtansine vs. lapatinib plus capecitabine in Chinese patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy. Transl Breast Cancer Res. 2023 Jan 31;4:3. doi: 10.21037/tbcr-23-2. eCollection 2023.
Other Identifiers
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BO29919
Identifier Type: -
Identifier Source: org_study_id
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