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

NCT01964391 | Completed Phase 3

• 1 other identifier: ML28851
• Study Type: interventional
• Target: 174
• Locations: 4 countries
• Sites: 19

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

Outcome Measures

Primary Outcomes (2)

• Participant Satisfaction Questionnaire Score

  Week 52

• Percentage of Participants with Adverse Events (AEs)

  Baseline up to 4.5 years

Secondary Outcomes (7)

• Healthcare Professional Experience and Satisfaction Questionnaire Score

  Week 52

• Overall Survival (OS)

  Baseline until death from any cause (up to 4.5 years)

• Disease-Free Survival (DFS)

  Baseline until first documented disease or death, whichever comes first (up to 4.5 years)

• Number of Days on Trastuzumab Treatment

  Baseline up to 1 year

• Total Daily Dose of Trastuzumab

  Baseline up to 1 year

Study Arms (1)

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.

Drug: Trastuzumab; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Docetaxel; Drug: Carboplatin; Drug: Neo-adjuvant chemotherapy

Interventions

Trastuzumab 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).

Also known as: Herceptin

Trastuzumab

Doxorubicin 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.

Trastuzumab

Cyclophosphamide 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.

Trastuzumab

Paclitaxel DRUG

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

Trastuzumab

Docetaxel DRUG

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

Trastuzumab

Carboplatin 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.

Trastuzumab

Neo-adjuvant chemotherapy 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.

Trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (23)

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

Algiers, 16016, Algeria

Location

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

Algiers, 16340, Algeria

Location

CHU Annaba; Service d'Oncologie Médicale

Annaba, 23000, Algeria

Location

EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale

Oran, 31000, Algeria

Location

Clinique Littoral

Casablanca, 20052, Morocco

Location

Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

Marrakesh, 40000, Morocco

Location

Institut National D'oncologie Sidi Med Benabdellah

Rabat, 6213, Morocco

Location

International Medical Center (IMC)

Jeddah, 21451, Saudi Arabia

Location

King Khaled Uni Hospital; Oncology

Riyadh, 11472, Saudi Arabia

Location

Abderrahmen Mami Hospital; Medical Oncology department

Aryanah, 2080, Tunisia

Location

Habib Bourguiba Hospital; Oncology department

Sfax, 3029, Tunisia

Location

Farhat Hached Hospital; Oncology department

Sousse, 4031, Tunisia

Location

Institut Salah Azaïz; Service de Médecine Carcinologique

Tunis, 1029, Tunisia

Location

Gazi University Medical Faculty; Department of İnternal Medicine

Ankara, 06500, Turkey (Türkiye)

Location

Akdeniz Univesity Medical Faculty

Antalya, 07058, Turkey (Türkiye)

Location

Dicle University Faculty of Medicine

Diyarbakır, 21280, Turkey (Türkiye)

Location

Trakya University Medical Faculty

Edirne, 22030, Turkey (Türkiye)

Location

Gaziantep Univ. Med. Fac.

Gaziantep, 27310, Turkey (Türkiye)

Location

İstanbul Üniversitesi Cerrahpaşa Tıp Fakültesi

Istanbul, 34098, Turkey (Türkiye)

Location

Bezmialem Vakif Univ Medical

Istanbul, 34286, Turkey (Türkiye)

Location

Marmara Uni Faculty of Medicine; Medical Oncology

Istanbul, 34890, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Hacettepe Uni Medical Faculty Hospital; Oncology Dept

Sıhhiye, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Doxorubicin; Cyclophosphamide; Paclitaxel; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 17, 2013
• Study Start: February 21, 2014
• Primary Completion: December 22, 2016
• Study Completion: November 25, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-04

Locations

TU (10); MO (3); SA (2); AL (4)