Trotabresib in Combination With Vinorelbine and Radiation Therapy for the Treatment of HER2+ Breast Cancer With Central Nervous System or Leptomeningeal Metastasis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06137651
Phase
PHASE1
Status
Withdrawn

Conditions

  • Breast Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Malignant Neoplasm in the Leptomeninges

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Resection — PROCEDURE
    Undergo surgery
  • Trotabresib — DRUG
    Given PO
  • Vinorelbine — DRUG
    Given IV

Study Details

This phase I/Ib trial tests the safety, side effects, and best dose of vinorelbine when given in combination with trotabresib in treating patients with HER2 positive breast cancer that has spread to the central nervous system or leptomeninges (metastasis). Cancer cells that make too much HER2 may grow more quickly and are more likely to spread to other parts of the body as metastases, including the central nervous system. Trotabresib is part of a family of drugs called BET inhibitors. Trotabresib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vinorelbine is in a class of medications called vinca alkaloids. It works by slowing or stopping the growth of cancer cells in your body. Giving trotabresib and vinorelbine may increase in the anti-cancer activity of vinorelbine when used in combination with radiation (radiotherapy).

Key Dates

Start date
Dec 31, 2023
Status verified
Mar 2024
Primary completion
Mar 27, 2024
Completion
Mar 27, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (radiation therapy, trotabresib, vinorelbine)
    Patients CNS metastases or LMD undergo radiation therapy over 7 days in the absence of disease progression or unacceptable toxicity. Patients then receive trotabresib PO QD on days 1-4 and vinorelbine IV over 6-10 minutes on days 4, 11, and 18 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, CT, and collection of blood samples throughout the trial.
  • Experimental: Cohort S (surgery, trotabresib, vinorelbine)
    Patients who undergo tumor resection receive trotabresib PO QD on days 1-4 and vinorelbine IV on day 4. Patients then undergo standard of care surgery. Patients may undergo radiation therapy after surgery per standard of care. Patients may then receive trotabresib PO QD on days 1-4 and vinorelbine IV over 6-10 minutes on days 4, 11, and 18 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo MRI, CT, and collection of blood samples throughout the trial.

Primary Outcome Measure

Dose limiting toxicities (Phase I) [ Time Frame: Up to 28 days after treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Northwestern University· Chicago, IL

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