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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01663727
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
* ECOG performance status of 0 or 1
* For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception
* For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization
Exclusion Criteria:
Disease-Specific Exclusions:
* HER2-positive status
* Prior chemotherapy for locally recurrent or metastatic disease
* Prior hormonal therapy \< 2 weeks prior to randomization
* Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization
* Investigational therapy within 28 days of randomization
General Medical Exclusions:
* Life expectancy of \< 12 weeks
* Inadequate organ function
* Uncontrolled serious medical or psychiatric illness
* Active infection requiring intravenous (IV) antibiotics at screening
* Pregnancy or lactation
* History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01663727
Study Brief:
Protocol Section:
NCT01663727