Prospective Study of UDP-gluconoryltransferase 2B17 Genotype as a Predictive Marker of Exemestane PK and PD

This is an interventional treatment trial for Breast Carcinoma focused on measuring hormone receptor positive, breast cancer Read More

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.