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RecruitingPhase 1

Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Phase 1b Study of Olaparib and Estradiol in Advanced ER+ Breast Cancer (PHOEBE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of olaparib with 17b-estradiol and finds the dose to use in the next phase of testing. It is for women past menopause who have advanced ER-positive, HER2-negative breast cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women past menopause with breast cancer that uses estrogen to grow (ER-positive) and is HER2-negative.
  • Cancer has spread to distant parts of the body or returned nearby and cannot be treated with the goal of a cure.
  • Have had at least one hormone-based treatment for advanced or spreading breast cancer.

Who can't join

  • Getting other cancer treatments during the study. Medicines that slow bone loss, such as bisphosphonates or denosumab, are allowed.
  • Had an experimental cancer treatment or chemotherapy that travels through the body in the past 3 weeks.
  • Had radiation treatment in the past 2 weeks.
  • Have known disease in the brain or spinal cord, unless it has been stable for at least 3 months.
  • Taking medicines that strongly or moderately block CYP3A, a protein that helps the body break down medicines.
  • Still have moderate or worse side effects from past cancer treatment.
  • Have a history of a blood clot in a deep vein or lung, stroke, heart attack, or heart failure.
  • Have a history of another cancer not treated with the goal of a cure or with at least a 30% chance of returning, or severe kidney problems (creatinine clearance of 30 mL/min or less).

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

NH