Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Description

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.

Conditions

Metastatic Breast Cancer

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Study Overview

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Study Details

Study overview

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.

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

Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Condition
Metastatic Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Lebanon

Dartmouth Cancer Center, Lebanon, New Hampshire, United States, 03756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * During study treatment, no concurrent anti-cancer therapies are allowed with the following exceptions:
  • * 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mary D Chamberlin,

Mary Chamberlin, MD, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

2028-12