Determine the safety and recommended Phase II dose of olaparib in combination with 17b-estradiol in post-menopausal patients with advanced ER+/HER2- breast cancer.
Patients with endocrine-resistant ER+/HER2- breast cancer are eligible. Patients will be treated with the combination of 17b-estradiol and olaparib for 2 cycles, and then treated with single-agent 17b-estradiol until disease progression. Clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Participants will be treated with olaparib at the approved doses for the treatment of subtypes of breast cancer or at reduced dose/frequency for participants with moderate renal impairment.
17b-estradiol will be taken orally three times per day.
Dartmouth Cancer Center
Lebanon, New Hampshire, United States
RECRUITINGDetermine the Phase II dose of olaparib in combination with 17b-estradiol
Determine the safety and recommended Phase II dose of olaparib in combination with 17b-estradiol in post-menopausal patients with advanced ER+/HER2- breast cancer.
Time frame: 8 weeks
Clinical benefit rate
The proportion of evaluable patients experiencing clinical benefit (stable disease at 24 weeks, complete or partial response per RECIST) will be measured.
Time frame: 6 months
Objective response rate
The proportion of evaluable patients experiencing objective response (complete or partial response per RECIST) will be measured.
Time frame: 6 months
Progression-free survival
Progression-free survival will be measured by measuring the length of time between the start of study treatment until the time of cancer progression or death from any cause.
Time frame: 12 months
Plasma Olaparib concentration
The concentration of Olaparib in plasma will be measured over 6 hours.
Time frame: 6 hours
Plasma 17b-Estradiol/Estrone concentration
The concentration of 17b-Estradiol/Estrone in plasma will be measured over 6 hours.
Time frame: 6 hours
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