Postmenopausal Women With ER+ HER2- Primary Breast Cancer Clinical Trial
Official title:
An Open Label, Randomised, Pre-surgical, Pharmacodynamics Study to Compare the Biological Effects of AZD9496 Versus Fulvestrant in Postmenopausal Women With ER Positive HER-2 Negative Primary Breast Cancer
This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare
and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with
estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2)
negative (HER2-) primary breast cancer.
Patients will receive AZD9496 or fulvestrant and will have an on-treatment image
-guided core biopsy after 5-14 days of commencing treatment.
This is an open label, randomized, multi-centre study in postmenopausal women with primary
ER+ HER2- breast cancer. Patients will be randomised to an oral dose of 250 mg bd AZD9496 or
500mg fulvestrant i.m. administered on one occasion. Patients diagnosed with primary breast
cancer who are scheduled for surgery with curative intent will be consented to the study
including consent to use the formalin fixed paraffin embedded (FFPE) diagnostic tumor biopsy
sample and fresh frozen tumor biopsy sample (if available) for research purposes. Patients
may also consent to provide an optional pretreatment fresh frozen tumor biopsy sample if this
was not obtained at the time of initial diagnostic biopsy. If the diagnostic biopsy was taken
≥ 6 weeks prior to starting treatment or was not of sufficient quality, new tumor core
biopsies (FFPE and fresh frozen) must be taken. Following the screening visit, eligible
patients will be randomised to receive one of the following study treatments:
- AZD9496 administered at 250 mg bd orally for 5-14 days commencing on Day 1, and
continuing up to the day of biopsy OR
- fulvestrant 500 mg administered as two consecutive 5 ml intramuscular injections on Day
1, one in each buttock.
After the morning dose of AZD9496 on the day of biopsy dosing will be stopped. If following
initiation of AZD9496 treatment, dosing will be stopped if biopsy is postponed beyond Day 14.
Patients will be considered not evaluable for the study if biopsy is postponed beyond day 14
of AZD9496/fulvestrant treatment initiation. Core tumor biopsies will be taken at either the
time of definitive surgery or at a separate visit prior to surgery in the period between (and
including) day 5 and day 14. Subjects who are scheduled to start a subsequent neoadjuvant
therapy must have their core tumor biopsies performed before commencing neoadjuvant
treatment.
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