Breast CancerPhase 3NCT01964391
A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer
A Phase 3 study testing Trastuzumab, Doxorubicin and Cyclophosphamide in people with Breast Cancer, run by Hoffmann-La Roche at 23 sites in 5 countries.
Trial summary
This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. 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, Doxorubicin and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 21 Feb 2014to 25 Nov 2018
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Hormonal therapy will be allowed as per institutional guidelines
- Prior use of anti-HER2 therapy will be allowed, except for early breast cancer participants in the neo-adjuvant setting
- Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab, 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
- HER2-positive disease immunohistochemistry 3 plus (IHC3+) or in situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
- Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
- No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent 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 participants with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible
- Severe dyspnea at rest or requirement for supplementary oxygen therapy
- 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 9Show fewer
- 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, 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 5 countries.
23 sites in 5 countries
Turkey (Türkiye)10 sites
Gazi University Medical Faculty; Department of İnternal Medicine
Ankara, 06500
Akdeniz Univesity Medical Faculty
Antalya, 07058
Dicle University Faculty of Medicine
Diyarbakır, 21280
Trakya University Medical Faculty
Edirne, 22030
Gaziantep Univ. Med. Fac.
Gaziantep, 27310
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi
Istanbul, 34098
Bezmialem Vakif Univ Medical
Istanbul, 34286
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, 34890
Ege University Medical Faculty
Izmir, 35100
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, Ankara, 06100
Algeria4 sites
Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale
Algiers, 16016
Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale
Algiers, 16340
CHU Annaba; Service d'Oncologie Médicale
Annaba, 23000
EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale
Oran, 31000
Tunisia4 sites
Abderrahmen Mami Hospital; Medical Oncology department
Aryanah, 2080
Habib Bourguiba Hospital; Oncology department
Sfax, 3029
Farhat Hached Hospital; Oncology department
Sousse, 4031
Institut Salah Azaïz; Service de Médecine Carcinologique
Tunis, 1029
Morocco3 sites
Clinique Littoral
Casablanca, 20052
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
Marrakesh, 40000
Institut National D'oncologie Sidi Med Benabdellah
Rabat, 6213
Saudi Arabia2 sites
International Medical Center (IMC)
Jeddah, 21451
King Khaled Uni Hospital; Oncology
Riyadh, 11472
About this study
Official title: An Open-Label, Multinational, Multicenter, Phase IIIb Study With Subcutaneous Administration of Trastuzumab in Patients With HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction
This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab, Doxorubicin, Cyclophosphamide, Paclitaxel, Docetaxel
- 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 will be administered subcutaneously at a fixed dose of 600 mg (irrespective of body weight) every 3 weeks for 1 year (adjuvant or neo-adjuvant plus adjuvant therapy).
DoxorubicinDrug
Doxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion.
CyclophosphamideDrug
Cyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion.
PaclitaxelDrug
Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
DocetaxelDrug
Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
CarboplatinDrug
Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion.
Neo-adjuvant chemotherapyDrug
Neo-adjuvant chemotherapy will be administered according to local guidelines in combination with trastuzumab in the neo-adjuvant setting. The study protocol does not mention any specific neo-adjuvant chemotherapy drug names.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab | Experimental | In adjuvant setting trastuzumab will be administered in the following treatment regimens: (a) trastuzumab following surgery, chemotherapy (neo-adjuvant or adjuvant) and radiotherapy (if applicable); (b) trastuzumab following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; (c) trastuzumab in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. In neo-adjuvant setting, trastuzumab will be administered in combination with neo-adjuvant chemotherapy followed by adjuvant trastuzumab, for locally advanced (including inflammatory) breast cancer or tumors greater than (>) 2 centimeters (cm) in diameter. Receives: Drug: Trastuzumab; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Docetaxel; Drug: Carboplatin; Drug: Neo-adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction Questionnaire Score
Measured: Week 52
Percentage of Participants with Adverse Events (AEs)
Measured: Baseline up to 4.5 years
Secondary outcomes (7)
Healthcare Professional Experience and Satisfaction Questionnaire Score
Measured: Week 52
Overall Survival (OS)
Measured: Baseline until death from any cause (up to 4.5 years)
Disease-Free Survival (DFS)
Diagnosis of breast cancer relapse will be made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence include radiology, computed tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainty, disease relapse should be confirmed by histological or cytological examination of a suspicious lesion, if possible.
Measured: Baseline until first documented disease or death, whichever comes first (up to 4.5 years)
Number of Days on Trastuzumab Treatment
Measured: Baseline up to 1 year
Total Daily Dose of Trastuzumab
Measured: Baseline up to 1 year
Cumulative Dose of Trastuzumab
Measured: Baseline up to 1 year
Duration of Treatment, Follow-up, and Safety Observation
Measured: Baseline up to 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study start21 Feb 2014
- Primary completion22 Dec 2016
- Study completion25 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964391
- Sponsor's protocol ID
- ML28851
- Status last verified
- Apr 2019
- First submitted
- 8 Oct 2013
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multinational, Multicenter, Phase IIIb Study With Subcutaneous Administration of Trastuzumab in Patients With HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction
- ClinicalTrials.gov ID
- NCT01964391
- Acronym / sponsor ID
- ML28851
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2014 (actual)
- Primary completion
- 22 Dec 2016 (actual)
- Study completion
- 25 Nov 2018 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab | Experimental | Drug: Trastuzumab, Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Paclitaxel, Drug: Docetaxel, Drug: Carboplatin, Drug: Neo-adjuvant chemotherapyIn adjuvant setting trastuzumab will be administered in the following treatment regimens: (a) trastuzumab following surgery, chemotherapy (neo-adjuvant or adjuvant) and radiotherapy (if applicable); (b) trastuzumab following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; (c) trastuzumab in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. In neo-adjuvant setting, trastuzumab will be administered in combination with neo-adjuvant chemotherapy followed by adjuvant trastuzumab, for locally advanced (including inflammatory) breast cancer or tumors greater than (>) 2 centimeters (cm) in diameter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Hormonal therapy will be allowed as per institutional guidelines
- Prior use of anti-HER2 therapy will be allowed, except for early breast cancer participants in the neo-adjuvant setting
- Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab, 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
- HER2-positive disease immunohistochemistry 3 plus (IHC3+) or in situ hybridization (ISH) positive as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay
Key exclusion criteria (9 listed)
- 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 participants with other curatively treated malignancies who have been disease-free for at least 5 years, are eligible
- Severe dyspnea at rest or requirement for supplementary oxygen therapy
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAlso: HerceptinTrastuzumab will be administered subcutaneously at a fixed dose of 600 mg (irrespective of body weight) every 3 weeks for 1 year (adjuvant or neo-adjuvant plus adjuvant therapy). | Drug | Trastuzumab |
| DoxorubicinDoxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion. | Drug | Trastuzumab |
| CyclophosphamideCyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion. | Drug | Trastuzumab |
| PaclitaxelPaclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion. | Drug | Trastuzumab |
| DocetaxelDocetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion. | Drug | Trastuzumab |
| CarboplatinCarboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion. | Drug | Trastuzumab |
| Neo-adjuvant chemotherapyNeo-adjuvant chemotherapy will be administered according to local guidelines in combination with trastuzumab in the neo-adjuvant setting. The study protocol does not mention any specific neo-adjuvant chemotherapy drug names. | Drug | Trastuzumab |
Primary outcome
Participant Satisfaction Questionnaire Score
Time frame: Week 52
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline up to 4.5 years
7 secondary outcomes
Healthcare Professional Experience and Satisfaction Questionnaire Score
Time frame: Week 52
Overall Survival (OS)
Time frame: Baseline until death from any cause (up to 4.5 years)
Disease-Free Survival (DFS)
Time frame: Baseline until first documented disease or death, whichever comes first (up to 4.5 years)
Number of Days on Trastuzumab Treatment
Time frame: Baseline up to 1 year
Total Daily Dose of Trastuzumab
Time frame: Baseline up to 1 year
Cumulative Dose of Trastuzumab
Time frame: Baseline up to 1 year
Duration of Treatment, Follow-up, and Safety Observation
Time frame: Baseline up to 4.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab, Doxorubicin and Cyclophosphamide in people with Breast Cancer, run by Hoffmann-La Roche at 23 sites in 5 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 9 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 2 Apr 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 Turkey (Türkiye), Algeria, Tunisia, Morocco, Saudi Arabia. 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?
Participant Satisfaction Questionnaire Score (time frame: Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2019.