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A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer (CLEE011A 2201)

Primary objective: To estimate the difference in anti-proliferative activity of LEE011 600 mg QD and LEE011 400 mg QD in combination with letrozole 2.5 mg QD vs single agent letrozole 2.5 mg QD as measured by changes in Ki-67 levels from baseline to…

RANDOMIZED PHASE II/III STUDY OF SECOND-LINE ENDOCRINE TREATMENT FOLLOWED BY CAPECITABINE VERSUS CAPECITABINE FOLLOWED BY ENDOCRINE TREATMENT IN PATIENTS WITH METASTATIC ER POSITIVE BREAST CANCER

This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time…

An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer (CRAD001Y24135)

Primary: to estimate progression-free survival in patients treated with everolimus + letrozole in the first line setting.Secondary: overall response rate, clinical benefit rate, overall survival in the first line setting, progression free survival…

A phase II randomized, double-blind placebo controlled, study of letrozole with or without BYL719 or
buparlisib, for the neoadjuvant treatment of postmenopausal women with hormone receptor-positive
HER2-negative breast cancer (CBYL719A2201)

Primary objective: Determine whether treatment with a PI3K inhibitor (BYL719 or buparlisib) plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with hormone receptor-positive HER2-…

BYLIEVE: A phase II, multicenter, open-label, three-cohort, non-comparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after prior treatments

To assess the proportion of patients who are alive without disease progression at 6 months based on local investigator assessment per RECIST v1.1 in cohort A and cohort B 13-03-2019: new cohort added (3 cohorts now)

Tailoring neoadjuvant therapy in hormone receptor positive, HER2 negative, luminal breast cancer.

Primary objective:• Determine if ribociclib plus letrozole gives a >=100% improvement in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) as compared to chemotherapy in the surgical specimen*.Secondary objective• Study the…