CompletedPhase 3

A Study to Investigate the Tolerability of Subcutaneous (SC) Trastuzumab Administration in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Early Breast Cancer (eBC) Using Either a Single-Use Injection Device or Manual Administration

Belarus, Kazakhstan90 participantsStarted 2014-07-18

Plain-language summary

This multicenter study in participants with HER2-positive eBC will investigate participants' pain and discomfort of SC trastuzumab (Herceptin) administered either via a single-use injection device (SID) or via vial for manual administration using a hand-held syringe (SC vial). In total, participants will obtain at least 18 cycles/1 year of trastuzumab (4 cycles of intravenous \[IV\] and 14 cycles of SC trastuzumab).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Hormonal therapy allowed as per institutional guidelines * Left ventricular ejection fraction (LVEF) of greater than or equal to (\>/=) 55 percent (%) measured by echocardiography (ECHO) prior to first dose of trastuzumab * HER2-positive disease immunohistochemistry (IHC) 3+ 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) * Participants who have completed all (neo)adjuvant treatment or participants after adjuvant chemotherapy with doxorubicin and cyclophosphamide (AC) to whom the 4 subsequent cycles of trastuzumab in combination with paclitaxel or docetaxel are indicated per local practice * Not more than 3 months should have elapsed since the last dose of adjuvant chemotherapy in case of subsequent treatment scheme Exclusion Criteria: * Previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-HER2 agent * History of other malignancy that can affect compliance with the protocol or interpretation of results. Participants with curatively treated carcinoma in situ of …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Participant Pain as Measured on a 10 Centimeter (cm) Visual Analogue Scale

Timeframe: Week 13 up to Week 52

Participant Discomfort as Measured on a 10 cm Visual Analogue Scale

Timeframe: Week 13 up to Week 52

Trial details

NCT IDNCT02194166

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-12

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