AzTrials
AzTrials

Breast CancerPhase 3NCT01926886

A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)

A Phase 3 study testing Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 23 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC. Participants who have completed the first 6 cycles of intravenous (IV) trastuzumab as part of the (neo)adjuvant treatment will be eligible to receive a further 12 cycles of… 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
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
23 sitesin 2 countries
Study dates
19 Nov 2013to 19 Jul 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
  • HER2-positive disease immunohistochemistry (IHC)3+ or in situ hybridization (ISH) positive, in line with local reimbursement criteria and determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Hormonal therapy will be allowed as per institutional guidelines
  • Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 50% measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC, or, for those who were receiving trastuzumab when beginning the study, documented results within an acceptable limit from a cardiac assessment within 3 months prior to enrollment
  • Participants have completed the first 6 cycles of trastuzumab IV as part of the (neo)adjuvant treatment
  • No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, (neo-adjuvant or adjuvant)
  • Use of concurrent curative radiotherapy will be permitted

Who cannot join

  • History of other malignancy which could affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma, and patients with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible
  • Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
  • Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
  • Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension
  • Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Pregnant or lactating women
Show all 10Show fewer
  • Women of childbearing potential and male participants with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment
  • Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
  • Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
  • Inadequate bone marrow, hepatic or renal function

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

Belgium13 sites

  • Onze Lieve Vrouwziekenhuis Aalst

    Aalst, 9300

  • Imeldaziekenhuis

    Bonheiden, 2820

  • AZ Sint Jan

    Bruges, 8000

  • CHU St Pierre (St Pierre)

    Brussels, 1000

  • AZ Maria Middelares

    Ghent, 9000

  • AZ Sint Lucas (Sint Lucas)

    Ghent, 9000

  • UZ Gent

    Ghent, 9000

  • CH Jolimont - Lobbes (Jolimont)

    Haine-Saint-Paul, 7100

  • Clinique Saint-Joseph

    Liège, 4000

  • CHU Ambroise Paré

    Mons, 7000

  • CHR de Namur

    Namur, 5000

  • AZ Damiaan

    Ostend, 8400

  • AZ Turnhout Sint Elisabeth

    Turnhout, 2300

Other trials in Belgium

Israel10 sites

  • Soroka Medical Center; Oncology Dept

    Beersheba, 8410100

  • Rambam Medical Center; Oncology

    Haifa, 3109601

  • Hadassah Ein Karem Hospital; Oncology Dept

    Jerusalem, 9112000

  • Meir Medical Center; Oncology

    Kfar Saba, 4428164

  • Western Galilee Hospital; Oncology-Nahariya

    Nahariya, 2210001

  • Rabin MC; Davidof Center - Oncology Institute

    Petah Tikva, 4941492

  • Chaim Sheba medical center, Oncology division

    Ramat Gan, 5262000

  • Kaplan Medical Center; Oncology Inst.

    Rehovot, 7610001

  • Sourasky / Ichilov Hospital; Dept. of Oncology

    Tel Aviv, 6423906

  • Assaf Harofeh; Oncology

    Tsrifin, 6093000

Other trials in Israel

About this study

Official title: A Single Arm Multi-center Study Investigating the at Home Administration of Trastuzumab Subcutaneous Vial for the Treatment of Patients With HER2-positive Early Breast Cancer

This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC. Participants who have completed the first 6 cycles of intravenous (IV) trastuzumab as part of the (neo)adjuvant treatment will be eligible to receive a further 12 cycles of trastuzumab in this study. Participants will receive IV trastuzumab at initial loading dose of 8 milligrams per kilogram (mg/kg) body weight (BW) for three-weekly (q3w) regimen and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (cycles 7-9) in hospital followed by subcutaneous (SC) administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18).

Conditions
Breast Cancer
Being tested
Trastuzumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w; Trastuzumab 600 mg q3w SC injection will be administered as per the schedule specified in the arm.

Study groups in NCT01926886
Study groupRoleWhat they receive
TrastuzumabExperimentalParticipants with HER2+ eBC who completed the first 6 cycles of trastuzumab IV infusion as part of the (neo) adjuvant treatment will be included to continue to receive 12 cycles of trastuzumab to complete a total of 18 cycles of trastuzumab. Participants will receive trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).
Receives: Drug: Trastuzumab
Health Care ProfessionalsNo interventionHealth Care Professionals (HCPs) included for polling purposes. HCPs were not enrolled in the study.

What is being measured

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

  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.

    Measured: Up to 45 months

Secondary outcomes (8)

  1. Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital

    PSQ1 is a quality of care questionnaire containing 14 questions each of Sections A and B, with a total of 28 questions categorized on the opinion of participants about the clinicians, opinion of participants about the other staff and other questions. Responses to questions with section A (except question 11) were categorized to "not at all", "to a small extent", "to a moderate extent", "to a large extent", "to a very large extent", "Not applicable" and "missing". Responses to questions with section B were categorized to "Not important", "a little important", "important", "very important", "of utmost importance", "not applicable" and "missing". Responses to question 11 with section A were categorized to "Yes, but not long", "yes, quite long", "yes, much long" and "missing". Participant experience with the treatment provided during the in-hospital part of the study was evaluated with PSQ1 questionnaire completed by the participant prior to the first dose of trastuzumab SC at home.

    Measured: Prior (0 hour) to first trastuzumab SC administration at Cycle 13 (cycle length =21 days)

  2. Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home

    PSQ2 is a quality of care questionnaire containing 13 questions each of Sections A and B, with a total of 26 questions categorized on the opinion of participants about the clinicians, opinion of participant about the other staff and other questions. Responses to questions with section A were categorized to "Not at all", "To a small extent", "to a moderate extent", "to a large extent", "to a very large extent", "Not applicable" and "missing". Responses to questions with section B were categorized to "Not important", "a little important", "important", "very important", "of utmost importance", "not applicable" and "missing". Participant experience with the treatment provided during the at-home part of the study was evaluated with the PSQ2 questionnaire completed by the participant prior to the fifth dose of trastuzumab SC at home.

    Measured: Prior (0 hour) to fifth trastuzumab SC administration at Cycle 17 (cycle length=21 days)

  3. Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire

    MDASI questionnaire is used to rate the severity of 13 core items (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness, numbness or tingling). Participants were asked to rate the severity of each symptom "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine." Total score was summed and ranged from 0 to 130, with lower scores indicating better outcome.

    Measured: Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)

  4. Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire

    MDASI questionnaire is used to rate the interference of symptoms. The measure includes 6 symptom interference items which ask how much all symptoms, interfere with domains (general activity, mood, work, relations with others, walking, and enjoyment of life). Each items were rated on a 0-10 scale (0 = "did not interfere"; 10 = "interfered completely"). Lower scores indicating better outcome. Total score was summed and ranged from 0 to 50, with lower scores indicating better outcome.

    Measured: Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)

  5. Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital

    PEX-Part 1 questionnaire contains 25 items to assess participant's experience on use of trastuzumab at hospital.1.Place of treatment? 2.Was it same place as for chemotherapy? 3.How long did it take to travel there? 4.How easy was travel? 5.Company required for travelling? 6.Was travelling cost a problem? 7.Considering all these,was travelling for treatment overall a problem? 8.How helpful were nursing/medical staff? 9.How pleasant was place of study? 10.How was IV treatment given? 11.If Venous Access Device(VAD),what was it? 12.Did hospital staff have difficulty inserting cannula? 13.Time for cannulation? 14.How painful was IV? 15.How much time to access port/line usually take? 16.How painful was it? 17.Time for IV sessions? 18.Anxiety level while IV treatment? 19.How would you describe IV sessions? 20.Did hospital staff have difficulty giving SC? 21.Time for SC? 22.How painful was SC? 23.Time for SC sessions? 24.Anxiety level while SC treatment? 25.How would you describe SC sessions?

    Measured: Prior (0 hours) to Cycle 12 (cycle length=21 days)

  6. Number of Participants With Modalities Assessed Using PEX - Part 2: At Home

    PEX - Part 2 questionnaire contains 6 items to assess the participant's experience on the use of trastuzumab SC vials at home.Participants answered the following questions: 1. Did the nursing staff ever have any difficulty giving the trastuzumab injection SC? 2. How many minutes did the injection (it) usually take? 3. How painful was this usually? 4. How long did the SC sessions usually last from arrival until departure of the nurse? 5. How anxious did having the SC treatment make you feel? 6. In general how would you describe these SC treatment sessions at home?

    Measured: 1 month after end of treatment (up to 10 months)

  7. Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1)

    HCPEX-1 questionnaire is used to assess health care professional's overall satisfaction and perceived time savings with trastuzumab SC vial in the hospital. The HCPEX-1 questionnaire (19 questions) was completed by the health care professionals administering the trastuzumab IV and SC in the hospital after at least 3 participants had completed the in-hospital part of the study.

    Measured: Prior (0 hours) to Cycle 12 (cycle length=21 days)

  8. Disease-Free Survival (DFS) as Assessed by Routine Clinical, Radiological and Laboratory Criteria

    DFS was defined as time from first study drug administration (i.e. Day 1 of Cycle 7) to local, regional or distant recurrence, contralateral breast cancer or death from any cause (whichever occurred first). Diagnosis of breast cancer relapse was made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence included radiology, computerized tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainly, disease relapse was to be confirmed by histological or cytological examination of a suspicious lesion, if possible.

    Measured: From start of treatment up to 45 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 Aug 2013 (estimated)
  2. Study start19 Nov 2013
  3. Primary completion4 Sep 2015
  4. Study completion19 Jul 2017

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01926886
Sponsor's protocol ID
ML28794
Other IDs
2013-000123-13
Status last verified
Aug 2019
First submitted
19 Aug 2013
Last updated
18 Sep 2019

Publications

  • Denys H, Martinez-Mena CL, Martens MT, D'Hondt RG, Graas ML, Evron E, Fried G, Ben-Baruch NE, Vulsteke C, Van Steenberghe MM. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020 May;181(1):97-105. doi: 10.1007/s10549-020-05604-7. Epub 2020 Apr 2.

    PubMed 32240454

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 23 sites in 2 countries.

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 8 inclusion and 10 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Belgium, Israel. 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?

Yes. Results are posted in the registry (first posted 18 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 45 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 NCT01926886, 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 18 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in