A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Trastuzumab

• Registration Number: NCT01810393
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Study Start: 2013-06-11
• Primary Completion: 2019-07-17
• Study Completion: 2019-07-17
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Histologically or cytologically confirmed HER2-positive metastatic breast cancer
• On treatment with first-line trastuzumab IV and free of disease progression for at least 3 years
• Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 50 percent (%)
• Hormonal therapy will be allowed
• Prior use of anti-HER2 therapy will be allowed

Exclusion Criteria

• History of other malignancy, except for 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; participants with previous ductal carcinoma in situ of the breast are also eligible
• Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
• Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
• Hepatitis B, hepatitis C or human immunodeficiency virus infection
• Pregnant or lactating women
• Concurrent enrollment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate 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 including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, for example, difficult to control asthma
• Central nervous system metastases, unless they have been treated and have been stable for at least 3 years
• Inadequate organ function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Trastuzumab IV Then Trastuzumab SC	Trastuzumab	Participants will receive treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.
Trastuzumab SC Then Trastuzumab IV	Trastuzumab	Participants will receive treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score	Baseline up to 6 cycles (cycle length = 21 days)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	approximately 4 years
Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score	Baseline up to 6 cycles (cycle length = 21 days)

Trial Locations

Locations (61)

Clinique Du Docteur Calabet; Cromg; 🇫🇷 Agen, France

Clinique De L Europe; Radiotherapie Chimiotherapie; 🇫🇷 Amiens, France

ICO Paul Papin; Oncologie Medicale.; 🇫🇷 Angers, France

HOP Prive Arras Les Bonnettes; Chimiotherapie; 🇫🇷 Arras, France

Institut Sainte-Catherine; Oncologie; 🇫🇷 Avignon, France

Centre Hospitalier de La Cote Basque; Oncologie; 🇫🇷 Bayonne, France

HOPITAL JEAN MINJOZ; Oncologie; 🇫🇷 Besancon, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Centre Hospitalier Fleyriat; Oncologie/Hematologie; 🇫🇷 Bourg En Bresse, France

Hopital Morvan; 🇫🇷 Brest, France

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