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Trial Title:
Estradiol Plus Olaparib for Breast Cancer (PHOEBE)
NCT ID:
NCT05900895
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Olaparib
Estradiol
Conditions: Keywords:
metastatic
locally advanced
estradiol therapy
olaparib
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Single-arm, 3+3 design with a dose-expansion cohort.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Olaparib
Description:
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.
Arm group label:
Treatment Arm
Other name:
Lynparza
Intervention type:
Drug
Intervention name:
17b-estradiol
Description:
17b-estradiol will be taken orally three times per day.
Arm group label:
Treatment Arm
Other name:
Estrace
Summary:
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Post-menopausal women with ER+/HER2- breast cancer.
- Metastatic or locoregional recurrence not amenable to treatment with curative
intent.
- Received ≥1 prior line of endocrine-based therapy in the advanced/metastatic
setting.
Exclusion Criteria:
- During study treatment, no concurrent anti-cancer therapies are allowed with the
following exceptions:
o Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) permitted.
- Any investigational cancer therapy or systemic chemotherapy in the last 3 weeks.
- Any radiation therapy in the last 2 weeks.
- Known CNS disease, unless clinically stable for ≥ 3 months.
- Concomitant use of known strong or moderate CYP3A inhibitors.
- Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy.
- History of any of the following:
- Deep venous thrombosis
- Pulmonary embolism
- Stroke
- Acute myocardial infarction
- Congestive heart failure
- Previous malignancy not treated with curative intent, or with an estimated
recurrence risk ≥30%
- Severe renal impairment (creatinine clearance ≤ 30 mL/min).
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
August 2024
Completion date:
December 2028
Lead sponsor:
Agency:
Mary D Chamberlin
Agency class:
Other
Collaborator:
Agency:
Dartmouth-Hitchcock Medical Center
Agency class:
Other
Source:
Dartmouth-Hitchcock Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900895
