Hyperthermia and Olaparib in Treating Breast Cancer Patients With Chest Wall Recurrences

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT03955640
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Malignant Neoplasm in the Chest Wall
  • Recurrent Breast Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Given PO
  • Hyperthermia Treatment — PROCEDURE
    Undergo hyperthermia treatment
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Quality-of-Life Assessment — OTHER
    Ancillary studies

Study Details

This phase I trial studies the side effects and best dose of olaparib when given with hyperthermia in treating patients with breast cancer that has come back in the chest wall. Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hyperthermia treatment may kill or damage tumor cells by heating them to several degrees above normal body temperature. Giving olaparib and hyperthermia treatment may work better in treating patients with breast cancer that has come back in the chest well compared to standard of care.

Key Dates

Start date
May 20, 2019
Status verified
Dec 2025
Primary completion
Aug 26, 2021
Completion
Aug 26, 2021

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (olaparib, hyperthermia)
    Patients receive olaparib PO BID. Treatment continues for 4 weeks in the absence of disease progression and unacceptable toxicity. Beginning week 2, patients also undergo hyperthermia treatment over 1 hour twice weekly for 3 weeks in the absence of disease progression and unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 1 year post treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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