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First enrollment in the PATHFINDER study

Updated: Dec 7, 2022

We are pleased to communicate that the Pathfinder study recruitment is underway!

First patient has been included in the study at Hospital Clínico de Valencia.

This is a multicenter, open-label, non-comparative, three-arm, phase IIa clinical trial that is designed to evaluate the safety, tolerability, and efficacy of ipatasertib (GDC-0068) in combination with eribulin, capecitabine, or carboplatin plus gemcitabine for taxane-pretreated patients with unresectable locally advanced or metastatic Triple Negative Breast Cancer that is not amenable to resection with curative intent.

The Pathfinder study is a pilot study that includes a safety run-in period as an initial step of the non-comparative phase IIa in this patient population.

Patients will be followed to observe if they experience any significant toxicity during the first two treatment cycles. Once the dosing schedule of Ipatasertib has been established, the study enrollment will proceed including the rest of patients within each treatment arm (phase IIa) in order to gain further safety and efficacy data of the combined regimens.

Inclusion criteria:

- Female adults with a histologically confirmed diagnosis of Triple negative Breast Cancer that have progressed after one or two prior chemotherapy-based regimen. (At least one must have included a taxane)

- Unresectable locally advanced or metastatic disease documented by image

- Measurable disease according to RECIST 1.1.

- ECOG performance status of 0 to 1.

Exclusion criteria:

- Prior exposure to PI3K, mTOR, or AKT inhibitors.

- Has recently undergone major surgery without recovery

- Has recently received prior radiotherapy

- Has lung disease, active cardiac disease or active inflammatory bowel disease

The participating sites of the study are in Spain and Portugal.

We truly appreciate the entire investigator team’s involvement in the PATHFINDER study and the never ending collaboration of our study team.

Join our global team of oncologists to develop life-saving cancer trials. Get in touch with us to see what we can achieve!

Author: Carla Rioja



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