An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 02 Jan 2019
At a glance
- Drugs Balixafortide (Primary) ; Eribulin
- Indications Advanced breast cancer
- Focus Registrational; Therapeutic Use
- Sponsors Polyphor
- 20 Dec 2018 Status changed from planning to not yet recruiting.
- 20 Dec 2018 Planned initiation date changed from 1 Jan 2019 to 1 Mar 2019.
- 03 Dec 2018 According to a Polyphor media release, the company announced that FDA has agreed with the proposed indication for this treatment and confirmed the possibility to submit a filing for accelerated approval at the end of the recruitment on the basis of the analysis of the overall response rate (ORR), confirmed by an independent blinded review, and of the associated durability of response.