A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC
Status:
Unknown status
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC, in
the last decade there was no major improvement of hormonal therapy specifically for
premenopausal metastatic breast cancer. The median age of breast cancer is much younger, and
the proportion of young breast cancer (YBC) patients (less than 40) including premenopausal
women is much higher, in Asia, including Korea.
Capecitabine, the comparator in this trial, is an orally-administered fluoropyrimidine
derivative and has shown high efficacy and low toxicity in metastatic breast cancer patients.
Palbociclib is a CDK4/6 inhibitors, in combination with endocrine therapy showed marked
advance in hormone receptor-positive MBC in the post-menopausal setting. After a median
follow-up of 16.5 months, preliminary results from Part 1 of this Phase 2 trial suggest that
the combination of PD-0332991 with letrozole is superior to letrozole alone, and improved
objective response and disease control rates (52% vs 32% and 76% vs 47%, respectively) in
patients treated with the combination. These remarkable results may contribute to have much
benefit with endocrine therapy for premenopausal women. Most importantly, recent PALOMA-3
trial revealed superior results of adding palbociclib to fulvestrant (median PFS 9.2 vs 3.8
months, P<0.001).
Based on these rational backgrounds, the purpose of this phase II study is to assess the
safety and the clinical anti-tumor activity of exemestane plus goserelin acetate in
combination with palbociclib vs capecitabine in premenopausal hormone receptor-positive
advanced breast cancer patients