Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT01810393
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01810393
Study Brief:
Protocol Section:
NCT01810393