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

NCT ID: NCT01964391

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-21
• Study Completion Date: 2018-11-25

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

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).

Doxorubicin

Intervention Type: DRUG

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

Cyclophosphamide

Intervention Type: DRUG

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

Paclitaxel

Intervention Type: DRUG

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

Docetaxel

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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 chemotherapy

Intervention Type: DRUG

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: DRUG

Docetaxel

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Herceptin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale

Algiers, , Algeria

Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale

Algiers, , Algeria

CHU Annaba; Service d'Oncologie Médicale

Annaba, , Algeria

EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale

Oran, , Algeria

Clinique Littoral

Casablanca, , Morocco

Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

Marrakesh, , Morocco

Institut National D'oncologie Sidi Med Benabdellah

Rabat, , Morocco

International Medical Center (IMC)

Jeddah, , Saudi Arabia

King Khaled Uni Hospital; Oncology

Riyadh, , Saudi Arabia

Abderrahmen Mami Hospital; Medical Oncology department

Aryanah, , Tunisia

Habib Bourguiba Hospital; Oncology department

Sfax, , Tunisia

Farhat Hached Hospital; Oncology department

Sousse, , Tunisia

Institut Salah Azaïz; Service de Médecine Carcinologique

Tunis, , Tunisia

Gazi University Medical Faculty; Department of İnternal Medicine

Ankara, , Turkey (Türkiye)

Akdeniz Univesity Medical Faculty

Antalya, , Turkey (Türkiye)

Dicle University Faculty of Medicine

Diyarbakır, , Turkey (Türkiye)

Trakya University Medical Faculty

Edirne, , Turkey (Türkiye)

Gaziantep Univ. Med. Fac.

Gaziantep, , Turkey (Türkiye)

İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi

Istanbul, , Turkey (Türkiye)

Bezmialem Vakif Univ Medical

Istanbul, , Turkey (Türkiye)

Marmara Uni Faculty of Medicine; Medical Oncology

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sıhhiye, Ankara, , Turkey (Türkiye)

Countries

Algeria; Morocco; Saudi Arabia; Tunisia; Turkey (Türkiye)

Other Identifiers

ML28851

Identifier Type: -

Identifier Source: org_study_id