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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT01655004
Eligibility Criteria:
Inclusion Criteria:
* Female, Age ≥ 21 years
* Histologically-proven hormone-receptor positive metastatic breast carcinoma
* A minimum of one prior line of endocrine therapy in the metastatic setting. First-line therapy is permitted if the patient relapses while on or within 6 months of adjuvant endocrine therapy.
* Patients with both measurable and non-measurable disease as per the Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 may be enrolled.
* Eastern co-operative group (ECOG) performance status of \< 2 and estimated life expectancy of at least 12 weeks
* Post-menopausal women\* or pre-menopausal women on ovarian suppression with FSH and plasma oestradiol levels in menopausal range within 21 days of study enrollment
* Adequate organ function including the following:
Bone marrow:
* Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109/L
* Platelets ≥ 100 x 109/L
Hepatic:
* Bilirubin ≤ 1.5 x upper limit of normal (ULN),
* ALT and AST ≤ 2.5x ULN
Renal:
o Calculated creatinine clearance \>35ml/minute
* Signed informed consent from patient or legal representative
* Pre-menopausal females must have a negative serum pregnancy test within 21 days of study enrollment
Exclusion Criteria:
* Concurrent administration of other anti-tumor therapies, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy are prohibited. Concomitant bisphosphonates and gonadotropin-releasing hormone therapy are allowed.
* Patients must have recovered from the toxicities of the previous anti-cancer therapy.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Prior use of exemestane in the metastatic setting or relapse while on adjuvant exemestane or within 6 months of completing adjuvant exemestane.
* Major surgery within 28 days of study drug administration.
* Concomitant use of potent CYP3A4 inducers (Table 1, section 3.5.3); a washout period of 14 days is required for patients discontinuing these medications prior to study enrollment.
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* Pregnancy.
* Breast feeding.
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
* Symptomatic brain metastasis.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
99 Years
Study:
NCT01655004
Study Brief:
Protocol Section:
NCT01655004