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Association details:
| Biomarker: | HR positive + AR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | fulvestrant (Selective estrogen receptor degrader) + pruxelutamide (GT0918) (Androgen receptor antagonist, TMPRSS2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Proxalutamide plus Endocrine Therapies in Women with HR+/HER2-/AR+ Metastatic Breast Cancer: A Phase Ic Study
Published date:
12/02/2023
Excerpt:
Efficacy analysis indicated that the ORR was 16.7% (2/12,95% CI, 2.1%-48.4%) for cohort C and 15.0% (3/20; 95% CI, 3.2%-37.9%) for part 2. Patients achieved a median progression-free survival (PFS) of 6.4 months (95% CI, 2.7-19.3) in cohort C while an mPFS of 11.0 months (95% CI, 5.5- not estimable) in part 2….These findings suggested favorable clinical outcomes and safety profiles of the combination of proxalutamide and fulvestrant in AR+/HR+/HER2- mBC patients who have progressed on the first-line therapy, and maybe with better efficacy in patients with lower AR/ER ratio.
Source:
Title:
408P - Proxalutamide plus endocrine therapy as a combination therapy in women with HR+/HER2-/AR+ metastatic breast cancer: A phase I study
Published date:
10/16/2023
Excerpt:
...proxalutamide plus fulvestrant achieved a partial response and 13 (34.2%) patients had stable disease, with an overall disease control rate of 50.0% (95% CI, 33.4%–66.6%; 38.9% in part 1 and 60.0% in part 2). The overall median PFS was 6.4 months (95% CI, 2.7-19.3) for cohort C and 11.0 months (95%CI: 5.5-NA) for cohort D....This study suggested a good antitumor activity and safety profile of the combination therapy of proxalutamide and fulvestrant for HR+/HER2-/AR+ mBC patients in the ≥2nd-line settings.
