Treatment of patients with advanced breast cancer harboring TP53 mutations with dose-dense cyclophosphamide - the p53 trial - p53 trial

Helse Bergen, Haukeland University Hospital0 sites190 target enrollmentAugust 22, 2016

Overview

No summary available.

Registry

who.int

Start Date

August 22, 2016

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Helse Bergen, Haukeland University Hospital

•\-Primary (T2 tumors or Locally advanced breast cancers; LABC) in need of pre\-surgical chemotherapy or metastatic breast cancer in need of chemotherapy.
•\-Resistance to endocrine therapy:
•Either i) estrogen and progesterone negative tumor, or ii) harboring an estrogen and / or progesterone positive tumor where regular endocrine therapies have failed or where the treating physician finds endocrine therapy not indicated.
•\-Prior cancer therapy:
•Metastatic disease:
•First line treatment:
•No prior chemotherapy\*. Prior endocrine therapy \+/\- CDK4/6 inhibitor or mTOR inhibitors is allowed if hormone receptor positive, HER2 negative disease.
•\* Only for patients with TP53 mutated disease. Previous adjuvant chemotherapy, including alkylating agents (cyclophosphamide a.o.) and/or platinum, is allowed if completed \>12 months prior to inclusion in the trial.
•Late\-stage disease (approved protocol):
•i) Prior exposure to and resistance to a taxane regimen\*\*.

•\-Co\-morbidity that, based on the assessment of the treating physician, may preclude the use of cyclophosphamide at actual doses.
•\-Psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow\-up schedule; those conditions should be discussed with the patient before registration in the trial
•\-Pregnant or lactating patients.
•\-Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
•\-Active cystitis (to be treated upfront)
•\-Active bacterial infections
•\-Urinary obstruction
•\-Known hypersensitivity towards cyclophosphamide or pegfilgrastim, their metabolites and other ingredients in the drug administration formulation.
•\-Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
•\-Patients with HER2 positive, metastatic breast cancer in the first line setting (Arm C).