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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT01229605
Eligibility Criteria:
Inclusion Criteria:
* Women 18 years of age or older
* Histologically documented adenocarcinoma of the breast, with T2 (T\>2.0 cm) N0 or more advanced disease.
* No evidence of metastatic disease.
* Disease must be clinically or radio-graphically measurable or evaluable.
* Incisional or core needle biopsy, yielding sufficient tissue for histologic confirmation of adenocarcinoma, hormone receptor analysis and Her2 testing; and Tiam-1 expression.
* Subjects may have received no prior chemotherapy for breast cancer. Subjects may have received up to 3 months of neoadjuvant hormonal therapy, provided they have been re-staged and are still eligible for this study, and have been off hormonal therapy at least 48 hours.
* Subject must be Her-2 negative.
* Performance status 0-1 by the ECOG scale.
* Baseline laboratory values must be as follows: Absolute granulocyte count: greater than 1400/cells/ml; Platelets: greater than 100,000 cells/ml; Total bilirubin: less than 1.5 mg/dl; Serum ALT: less than 2.5 x institutional upper normal limit; Creatinine: less than 1.6mg/dl; Hemoglobin: greater than 9.0g/dl
* Subjects must be nonpregnant and nonlactating. Subjects of childbearing potential must utilize an effective method of contraception during the study.
Exclusion Criteria:
* Subjects who have received chemotherapy or more than 3 months of neoadjuvant hormone therapy for this cancer.
* Subjects with metastatic disease (disease beyond the breast, axillary nodes and ipsilateral supraclavicular nodes) or inflammatory breast cancer (T4d).
* Subjects with other active cancers, except non-melanoma skin cancers
* Subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
* Dementia or significantly altered mental status that would prohibit comprehension of or giving of informed consent.
* Pregnant or breast-feeding women; sexually active, pre-menopausal women not willing to use adequate methods of birth control.
* Subjects who are Her 2 neu positive are excluded.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01229605
Study Brief:
Protocol Section:
NCT01229605