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:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT00392392
Eligibility Criteria:
Inclusion Criteria:
* Female patients with histologically confirmed adenocarcinoma of the breast or inflammatory breast cancer
* Clinical stage T 1-4, N 0-3, M0
* FISH+ HER2 gene amplified breast cancer
* 18 years or older
* Normal cardiac function
* Performance status 0-2
* Cannot have received any prior chemotherapy for this disease or cannot have received chemotherapy for any other cancer in the past 5 years.
* Previous diagnosis of noninvasive breast cancer is OK.
* Must have adequate bone marrow, renal and liver function.
* Pregnant or lactating females not allowed.
* Preexisting peripheral neuropathy must be equal to or less than grade 1
* Must have archived tumor tissue for tissue testing.
Exclusion Criteria:
You cannot be in this study if you any of the following:
* History of cardiac disease, with New York Heart Association Class II or greater with congestive heart failure
* Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias needing medication; no bleeding diathesis or coagulopathy.
* No prior investigational drug within the last 30 days
* No prior trastuzumab or bevacizumab therapy
There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00392392
Study Brief:
Protocol Section:
NCT00392392