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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT00647218
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically documented invasive carcinoma of the breast\*
* Tumor ≥ 2 cm in greatest dimension (e.g., T2-4) and any nodal status (e.g., N0-3), including locally advanced disease, as defined by the following criteria:
* Primary tumor ≥ 5 cm
* Tumor of any size with direct extension to the chest wall or skin
* Inflammatory breast cancer (T4d)
* Metastasis to ipsilateral internal mammary node
* Ipsilateral lymph nodes that are clinically fixed to each other or to other structures (N2) NOTE: \*Diagnosis may be made by core or tru-cut biopsies
* Measurable or evaluable tumor
* Measurable disease is defined as any mass that can be reproducibly measured in two perpendicular dimensions
* Evaluable disease is defined as any lesion visible by mammogram or palpable by physical exam that does not fit the above criteria of measurability
* Planning to undergo breast conservation surgery
* Willing to undergo AND is a candidate for radiotherapy, in the judgement of the treating radiation oncologist
* No evidence of distant metastatic disease (e.g., lung, liver, bone, brain)
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG performance status 0-1
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* Left ventricular ejection fraction ≥ 45%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancies within the past 5 years, except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
* No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
* No serious medical illness that, in the judgment of the treating physician, places the patient at risk
* No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
* Prior tamoxifen as chemoprevention allowed
* No prior radiotherapy to the ipsilateral breast
* Prior radiotherapy to the contralateral breast is allowed
* No prior chemotherapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00647218
Study Brief:
Protocol Section:
NCT00647218