NCT06137651

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

Withdrawn Phase 1 Last updated 1 April 2024

What this trial tests

Phase 1 trial testing Biospecimen Collection in Breast Carcinoma. Withdrawn.

Timeline

31 December 2023

Primary endpoint
27 March 2024

27 March 2024

Quick facts

Lead sponsor	Northwestern University
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	31 December 2023
Primary completion	27 March 2024
Estimated completion	27 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Computed Tomography
• Magnetic Resonance Imaging
• Radiation Therapy — full drug profile →
• Resection
• Trotabresib — full drug profile →
• Vinorelbine (vinorelbine) — full drug profile →

Conditions studied

• Breast Carcinoma — all drugs for Breast Carcinoma →
• Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →
• Metastatic Malignant Neoplasm in the Leptomeninges — all drugs for Metastatic Malignant Neoplasm in the Leptomeninges →

Sponsor

Northwestern University

Who can join

18 and older, any sex, with Breast Carcinoma or Metastatic Malignant Neoplasm in the Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Epigenetics-targeted drugs: current paradigms and future challenges.
   Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
2. Pharmacological targeting of the cancer epigenome.
   Mabe NW, Perry JA, Malone CF, Stegmaier K. · · 2024 · cited 36× · PMID 38937652 · DOI 10.1038/s43018-024-00777-2
3. How histone modifications influence cellular radiosensitivity: Pharmaceutically targeting epigenetic regulators as a promising avenue to overcome radioresistance.
   Song J, Ye L, Ding WQ, Qiao H, et al · · 2025 · PMID 41477347 · DOI 10.1016/j.apsb.2025.09.019
4. Current Evidence in the Systemic Treatment of Brain Metastases from Breast Cancer and Future Perspectives on New Drugs, Combinations and Administration Routes: A Narrative Review.
   Garrone O, Ruatta F, Rea CG, Denaro N, et al · · 2024 · PMID 39766062 · DOI 10.3390/cancers16244164
5. The global landscape of clinical trials and drug discovery for brain metastasis.
   Ding J, Jiang Y, Zhou J, Tang Q, et al · · 2024 · PMID 39107814 · DOI 10.1186/s12967-024-05310-8