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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT01124695
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the breast
* Stage III (locally advanced), metastatic, or recurrent disease
* Deemed not resectable
* Estrogen-receptor and/or progesterone-receptor positive disease
* Receptor status is based on most recent results
* Measurable or non-measurable disease
* ECOG performance status 0-2
* History of central nervous system (CNS) metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)
* Negative pregnancy test
* Fertile patients must use effective nonhormonal contraception
* Disease-free of prior invasive malignancies for ≥ 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy; other prior non-hormonal investigational agents in the adjuvant setting must have been completed at least 4 weeks prior to study registration and should be discussed with the study PI
* Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose
* Treatment in the advanced setting must have been completed at least 2 weeks prior to study initiation
* Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant or metastatic setting
* At least 2 weeks since prior and no concurrent medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen citrate metabolism including, but not limited to, any of the following:
* Paroxetine (Paxil)
* Fluoxetine (Prozac)
* Bupropion (Wellbutrin)
* Quinidine (Cardioquin)
* Concurrent radiotherapy to painful sites of bone disease or areas of impending fractures allowed provided the following criteria are met:
* Radiotherapy was initiated before study entry
* Sites of measurable or non-measurable disease are outside the radiotherapy port
* Recovered from prior radiotherapy
Exclusion Criteria:
* Pregnant or nursing
* Concurrent chemotherapy
* Leptomeningeal disease
* Non-protocol concurrent hormonal therapy
* Medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities
* Prior tamoxifen for advanced disease
* More than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics
* Starting bisphosphonate therapy while receiving treatment on this study
* Patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01124695
Study Brief:
Protocol Section:
NCT01124695