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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01964391
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Trastuzumab Drug: Doxorubicin Drug: Cyclophosphamide Drug: Paclitaxel Drug: Docetaxel Drug: Carboplatin Drug: Neo-adjuvant chemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 21, 2014
Actual Primary Completion Date : December 22, 2016
Actual Study Completion Date : November 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Trastuzumab
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.
Drug: Trastuzumab
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).
Other Name: Herceptin

Drug: Doxorubicin
Doxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion.

Drug: Cyclophosphamide
Cyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion.

Drug: Paclitaxel
Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.

Drug: Docetaxel
Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.

Drug: Carboplatin
Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion.

Drug: Neo-adjuvant chemotherapy
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.

Primary Outcome Measures :
  1. Participant Satisfaction Questionnaire Score [ Time Frame: Week 52 ]
  2. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to 4.5 years ]

Secondary Outcome Measures :
  1. Healthcare Professional Experience and Satisfaction Questionnaire Score [ Time Frame: Week 52 ]
  2. Overall Survival (OS) [ Time Frame: Baseline until death from any cause (up to 4.5 years) ]
  3. Disease-Free Survival (DFS) [ Time Frame: Baseline until first documented disease or death, whichever comes first (up to 4.5 years) ]
    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.

  4. Number of Days on Trastuzumab Treatment [ Time Frame: Baseline up to 1 year ]
  5. Total Daily Dose of Trastuzumab [ Time Frame: Baseline up to 1 year ]
  6. Cumulative Dose of Trastuzumab [ Time Frame: Baseline up to 1 year ]
  7. Duration of Treatment, Follow-up, and Safety Observation [ Time Frame: Baseline up to 4.5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01964391

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Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale
Algiers, Algeria, 16016
Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale
Algiers, Algeria, 16340
CHU Annaba; Service d'Oncologie Médicale
Annaba, Algeria, 23000
EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale
Oran, Algeria, 31000
Clinique Littoral
Casablanca, Morocco, 20052
Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie
Marrakech, Morocco, 40000
Institut National D'oncologie Sidi Med Benabdellah
Rabat, Morocco, 6213
Saudi Arabia
International Medical Center (IMC)
Jeddah, Saudi Arabia, 21451
King Khaled Uni Hospital; Oncology
Riyadh, Saudi Arabia, 11472
Abderrahmen Mami Hospital; Medical Oncology department
Ariana, Tunisia, 2080
Habib Bourguiba Hospital; Oncology department
Sfax, Tunisia, 3029
Farhat Hached Hospital; Oncology department
Sousse, Tunisia, 4031
Institut Salah Azaïz; Service de Médecine Carcinologique
Tunis, Tunisia, 1029
Gazi University Medical Faculty; Department of İnternal Medicine
Ankara, Turkey, 06500
Akdeniz Univesity Medical Faculty
Antalya, Turkey, 07058
Dicle University Faculty of Medicine
Diyarbakir, Turkey, 21280
Trakya University Medical Faculty
Edirne, Turkey, 22030
Gaziantep Univ. Med. Fac.
Gaziantep, Turkey, 27310
İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi
İstanbul, Turkey, 34098
Bezmialem Vakif Univ Medical
Istanbul, Turkey, 34286
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, Turkey, 34890
Ege University Medical Faculty
Izmir, Turkey, 35100
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, Ankara, Turkey, 06100
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01964391     History of Changes
Other Study ID Numbers: ML28851
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors