RECRUITING

Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

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Conditions

Metastatic Breast Cancermetastaticlocally advancedestradiol therapyolaparib

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-15
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05900895

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Post-menopausal women with ER+/HER2- breast cancer.
  2. * Metastatic or locoregional recurrence not amenable to treatment with curative intent.
  3. * Received ≥1 prior line of endocrine-based therapy in the advanced/metastatic setting.
  1. * During study treatment, no concurrent anti-cancer therapies are allowed with the following exceptions:
  2. * Any investigational cancer therapy or systemic chemotherapy in the last 3 weeks.
  3. * Any radiation therapy in the last 2 weeks.
  4. * Known CNS disease, unless clinically stable for ≥ 3 months.
  5. * Concomitant use of known strong or moderate CYP3A inhibitors.
  6. * Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy.
  7. * History of any of the following:
  8. * Deep venous thrombosis
  9. * Pulmonary embolism
  10. * Stroke
  11. * Acute myocardial infarction
  12. * Congestive heart failure
  13. * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%
  14. * Severe renal impairment (creatinine clearance ≤ 30 mL/min).

Contacts and Locations

Study Contact

Research Nurse
CONTACT
1-800-639-6918
Cancer.Research.Nurse@dartmouth.edu

Principal Investigator

Mary Chamberlin, MD
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Mary D Chamberlin

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-15
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-07-15
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • metastatic
  • locally advanced
  • estradiol therapy
  • olaparib

Additional Relevant MeSH Terms

  • Metastatic Breast Cancer