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Association details:
| Biomarker: | PIK3CA mutation |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) + MEN1611 (PI3K inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer (B-PRECISE-01)
Excerpt:
...Advanced or metastatic breast cancer harbouring PIK3CA mutation on tissue sample...
Trial ID:
Source:
Title:
PD18-05 MEN1611, a PI3K inhibitor, combined with trastuzumab ± fulvestrant for HER2+/PIK3CA mutant advanced or metastatic breast cancer: updated safety and efficacy results from the ongoing phase 1b study (B-PRECISE-01)
Published date:
11/22/2022
Excerpt:
In the efficacy-evaluable population at the RP2D (n=41) 14 patients (34.1%) showed partial response (MEN+T 5/15, MEN+T+F 9/26), 1 patient (2.4%) had a complete response (MEN+T 1/15) and 23 patients (56.1%) had stable disease (MEN+T 6/15, MEN+T+F 17/26) as best response....Updated results from B-PRECISE-01 demonstrated that MEN1611 combined with trastuzumab ± fulvestrant continued to show a manageable safety profile with encouraging anti-tumor activity and duration of response in heavily pre-treated patients with HER2+/PIK3CA-mutated advanced or metastatic breast cancer.
Secondary therapy:
fulvestrant
Source:
Title:
266P - MEN1611, a PI3K inhibitor, combined with trastuzumab (T) ± fulvestrant (F) for HER2+/PIK3CA mutant (mut) advanced or metastatic (a/m) breast cancer (BC): Safety and efficacy results from the ongoing phase Ib study (B-PRECISE-01)
Published date:
09/13/2021
Excerpt:
MEN combined with T ± F shows a manageable safety profile with encouraging duration of antitumoral activity in heavily pre-treated pts with HER2+/PIK3CAmut a/m BC.
Secondary therapy:
fulvestrant
Trial ID:
Source:
Title:
347P - Results of the phase Ib dose escalation study of MEN1611, a PI3K inhibitor, combined with trastuzumab (T) ± fulvestrant (F) for HER2+/PIK3CA mutant (mut) advanced or metastatic (a/m) breast cancer (BC)
Published date:
09/14/2020
Excerpt:
5 pts (42%) had partial response, 5 stable disease, 4 disease control >8 months (mo) and 2 were on treatment >11 mo....Promising antitumor activity in heavily pretreated pts, together with prolonged disease control, provide the rationale for cohort expansion at RP2D in pts with HER2+/PIK3CA mut a/m BC.
Secondary therapy:
fulvestrant
Trial ID:
Source:
Title:
Antitumor activity of the PI3K δ-sparing inhibitor MEN1611 in PIK3CA mutated, trastuzumab-resistant HER2 + breast cancer
Published date:
03/13/2023
Excerpt:
Here we investigate the activity of the PI3K inhibitor MEN1611 at both molecular and phenotypic levels by dissecting and comparing its profile and efficacy in HER2 + breast cancer models with other PI3K inhibitors....In vivo, MEN1611 monotherapy showed significant and durable antitumor activity in several trastuzumab-resistant PIK3CA-mutant HER2 + PDX models. The combination of trastuzumab and MEN1611 significantly improved the efficacy compared to single agent treatment.
DOI:
10.1007/s00432-023-04670-w
