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Breast CancerPhase 3NCT03084939

Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer

A Phase 3 study testing Trastuzumab Emtansine, Lapatinib and Capecitabine in people with Breast Cancer, run by Hoffmann-La Roche at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase III, randomized, multicenter, two-arm, open-label study designed to evaluate the safety and efficacy of trastuzumab emtansine compared with that of lapatinib + capecitabine in Chinese participants with HER2-positive, unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab Emtansine, Lapatinib and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
18 sitesChina
Study dates
24 Apr 2017to 14 Mar 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged >/= 18 years
  • 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
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  • 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

Who cannot join

  • History of treatment with trastuzumab emtansine
  • 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
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  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Beijing Hospital

    Beijing, 100006

  • The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

    Beijing, 100071

  • Beijing Cancer Hospital

    Beijing, 100142

  • the First Hospital of Jilin University

    Changchun, 130021

  • Jilin Cancer Hospital

    Changchun, 132013

  • Changzhou First People's Hospital

    Changzhou, 213003

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • The Second Affiliated Hospital of Zhejiang University College

    Hangzhou, 310009

  • Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Jiangsu Province Hospital

    Nanjing, 210008

  • Jiangsu Cancer Hospital

    Nanjing, 211100

  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

Other trials in China

About this study

Official title: A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab Emtansine Versus Lapatinib Plus Capecitabine in Chinese Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

This is a Phase III, randomized, multicenter, two-arm, open-label study designed to evaluate the safety and efficacy of trastuzumab emtansine compared with that of lapatinib + capecitabine in Chinese participants with HER2-positive, unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC) who have received prior trastuzumab-based therapy. A total of approximately 350 participants will be enrolled in China. The study will consist of 2 stages. Stage 1: Eligible participants will be randomized in a 3:1 ratio to receive either trastuzumab emtansine or control (lapatinib + capecitabine). Stage 2: After Stage 1 is recruited, eligible patients will be enrolled to receive trastuzumab emtansine only.

Conditions
Breast Cancer
Being tested
Trastuzumab Emtansine, Lapatinib, Capecitabine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trastuzumab EmtansineBiological

    Also called Kadcyla

    Trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) was administered intravenously on Day 1 of each 21-day cycle.

  • LapatinibDrug

    Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.

  • CapecitabineDrug

    Capecitabine 1000 milligrams per square meter (mg/m^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.

Study groups in NCT03084939
Study groupRoleWhat they receive
Trastuzumab EmtansineExperimentalParticipants 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.
Receives: Biological: Trastuzumab Emtansine
Control (lapatinib + capecitabine)Active comparatorParticipants 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.
Receives: Drug: Lapatinib; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version (v1.1), or death from any cause during the study, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeter (mm) taking as reference the smallest sum during the study including baseline or the appearance of one or more new lesions. Tumor assessments will be performed with computed tomography (CT) or magnetic resonance imaging (MRI) scans.

    Measured: Up to approximately 17 months

Secondary outcomes (10)

  1. Objective Response Rate (ORR)

    ORR is defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1. CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of the longest diameters of target lesions taking as reference baseline sum diameters; Objective Response Rate (OR) = CR + PR. Tumor assessments will be performed with CT or MRI scans.

    Measured: Up to approximately 29 months

  2. Duration of Response (DOR)

    DOR is defined as as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study. CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of the longest diameters of target lesions taking as reference baseline sum diameters. Disease progression was defined according to RECIST, v1.1 as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Tumor assessments will be performed with CT or MRI scans.

    Measured: Up to approximately 29 months

  3. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death from any cause.

    Measured: When at least 100 (50%) death events are observed from participants in Stage 1

  4. Number of Participants with Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Up to approximately 56 months

  5. Serum Concentration of Trastuzumab Emtansine Conjugate

    Concentration of trastuzumab emtansine conjugate will be measured in serum from participants, who received trastuzumab emtansine.

    Measured: Pre-dose and 15-30 minutes after dose on Day 1 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 56 months)

  6. Plasma Concentration of N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-maytansine (DM1)

    Concentration of the analyte DM1 will be measured in plasma from participants, who received trastuzumab emtansine.

    Measured: Pre-dose on Day 1 of Cycle 1, 15-30 minutes after dose on Day 1 of each 21-day cycle during Cycles 1-4

  7. Serum Concentration of Total Trastuzumab

    Concentration of total trastuzumab will be measured in serum from participants, who received trastuzumab emtansine.

    Measured: Pre-dose and 15-30 minutes after dose on Day 1 of each 21-day cycle during Cycles 1-4

  8. Percentage of Participants with Anti-therapeutic Antibodies (ATA) to Trastuzumab Emtansine

    ATA to trastuzumab emtansine were measured in serum of participants, who received trastuzumab emtansine.

    Measured: Pre-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4, at completion/early termination visit and 3 months after last dose of trastuzumab emtansine (up to approximately 56 months)

  9. Patient-reported Outcome: Percentage of Participants with Clinically Significant Deterioration

    The patient-reported outcome of clinically significant deterioration in physical well-being, functional well-being, and breast cancer symptoms will be determined by a decrease of >/= 5 points from baseline on the Performance/Functional/Breast (PFB) Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Breast (FACT-B, Version 4) questionnaire in female participants only. Reported here is the percentage of participants with clinically significant deterioration.

    Measured: Day 1 (prior to any study procedures or discussion of test results) of Cycle 1 (21 days) and every two cycles thereafter until treatment discontinuation and at the completion/early termination visit (up to approximately 56 months)

  10. Patient-reported Outcome: Time to Clinically Significant Deterioration

    The patient-reported outcome of clinically significant deterioration in physical well-being, functional well-being, and breast cancer symptoms will be determined by a decrease of >/= 5 points from baseline on the PFB TOI score of the FACT-B, Version 4 questionnaire in female participants only. Reported here is the time to clinically significant deterioration.

    Measured: Day 1 (prior to any study procedures or discussion of test results) of Cycle 1 (21 days) and every two cycles thereafter until treatment discontinuation (up to approximately 56 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2017
  2. Study start24 Apr 2017
  3. Primary completion23 Nov 2018
  4. Study completion14 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03084939
Sponsor's protocol ID
BO29919
Status last verified
May 2023
First submitted
15 Mar 2017
Last updated
6 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38751488

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab Emtansine, Lapatinib and Capecitabine in people with Breast Cancer, run by Hoffmann-La Roche at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Up to approximately 17 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03084939, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

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