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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT01082068
Eligibility Criteria:
Inclusion Criteria:
* The subject has histologically confirmed breast cancer that is ER+ and/or PGR+.
* The subject's breast cancer is negative for HER2.
* The subject has recurrent or metastatic breast cancer that is refractory to a nonsteroidal aromatase inhibitor and has either disease progression or disease recurrence.
* Subjects previously treated with letrozole must be able to tolerate the approved dose and schedule of letrozole.
* For subjects enrolled in Phase 2, either archival tumor samples must be available, or the subject must be willing to undergo a fresh biopsy.
* In Phase 2, at least 30 subjects in each arm must have measurable disease
* The subject is a postmenopausal female.
* If a subject is currently receiving bisphosphonates, the subject must have received the bisphosphonates for at least 2 months before starting study treatment.
* The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
* The subject has adequate organ and marrow function.
* The subject has no other diagnosis of malignancy or evidence of other malignancy for 2 years before screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).
* The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document.
Exclusion Criteria:
* The subject has received prior treatment with a selective inhibitor of PI3K, AKT, and/or mTOR.
* Certain restrictions on prior therapies apply.
* The subject has not recovered from toxicity due to prior therapy to Grade ≤ 1 or to pre-therapy baseline.
* The subject has untreated, symptomatic, or progressive brain metastases.
* The subject has only non-measurable lesions, other than bone, skin, or chest wall metastasis
* The subject has to start cytotoxic chemotherapy due to rapid progressive disease involving major organs.
* The subject has prothrombin time/ International Normalized Ratio (PT/ INR) or partial thromboplastin time (PTT) test results at screening that are above 1.3 x the laboratory upper limit of normal.
* The subject has uncontrolled significant intercurrent illness.
* The subject has a baseline corrected QT interval (QTc) \> 470 ms.
* The subject has a diagnosis of uncontrolled diabetes mellitus.
* The subject is known to be positive for the human immunodeficiency virus (HIV).
* The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation(s).
* The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01082068
Study Brief:
Protocol Section:
NCT01082068