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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01964391
• Other study ID #: ML28851
• Status: Completed
• Phase: Phase 3
• Start date: February 21, 2014
• Est. completion date: November 25, 2018

Study information

• Verified date: April 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: November 25, 2018
• Est. primary completion date: December 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Algeria	Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale	Algiers
Algeria	Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale	Algiers
Algeria	CHU Annaba; Service d'Oncologie Médicale	Annaba
Algeria	EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale	Oran
Morocco	Clinique Littoral	Casablanca
Morocco	Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie	Marrakech
Morocco	Institut National D'oncologie Sidi Med Benabdellah	Rabat
Saudi Arabia	International Medical Center (IMC)	Jeddah
Saudi Arabia	King Khaled Uni Hospital; Oncology	Riyadh
Tunisia	Abderrahmen Mami Hospital; Medical Oncology department	Ariana
Tunisia	Habib Bourguiba Hospital; Oncology department	Sfax
Tunisia	Farhat Hached Hospital; Oncology department	Sousse
Tunisia	Institut Salah Azaïz; Service de Médecine Carcinologique	Tunis
Turkey	Gazi University Medical Faculty; Department of Internal Medicine	Ankara
Turkey	Akdeniz Univesity Medical Faculty	Antalya
Turkey	Dicle University Faculty of Medicine	Diyarbakir
Turkey	Trakya University Medical Faculty	Edirne
Turkey	Gaziantep Univ. Med. Fac.	Gaziantep
Turkey	Bezmialem Vakif Univ Medical	Istanbul
Turkey	Istanbul Üniversitesi Cerrahpasa Tip Fakültesi	Istanbul
Turkey	Marmara Uni Faculty of Medicine; Medical Oncology	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye, Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Algeria,  Morocco,  Saudi Arabia,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Satisfaction Questionnaire Score		Week 52
Primary	Percentage of Participants with Adverse Events (AEs)		Baseline up to 4.5 years
Secondary	Healthcare Professional Experience and Satisfaction Questionnaire Score		Week 52
Secondary	Overall Survival (OS)		Baseline until death from any cause (up to 4.5 years)
Secondary	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.	Baseline until first documented disease or death, whichever comes first (up to 4.5 years)
Secondary	Number of Days on Trastuzumab Treatment		Baseline up to 1 year
Secondary	Total Daily Dose of Trastuzumab		Baseline up to 1 year
Secondary	Cumulative Dose of Trastuzumab		Baseline up to 1 year
Secondary	Duration of Treatment, Follow-up, and Safety Observation		Baseline up to 4.5 years