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Association details:
| Biomarker: | HER-2 positive |
|---|---|
| Cancer: | HER2 Positive Breast Cancer |
| Drug: | Herceptin (trastuzumab) (HER2 inhibitor) + Aliqopa (copanlisib) (PIK3CA inhibitor, PI3Kδ inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study)
Excerpt:
...Histologically confirmed HER2-positive breast cancer: Documented HER2 overexpression by local laboratory (IHC 3+ or FISH or CISH positive)....
Trial ID:
Source:
Title:
A study of copanlisib in combination with trastuzumab for treatment of women with HER2 positive advanced breast cancer.
Excerpt:
...Adult women ≥ 18 years of age with histologically confirmed, recurrent, or metastatic, HER2-positive breast cancer. ...
Trial ID:
Less C2 evidence
Source:
Title:
Phase Ib/II trial evaluating safety and efficacy of copanlisib (PI3K inhibitor) and trastuzumab in pre-treated advanced HER2-positive breast cancer: Results from the PantHER study
Published date:
10/09/2021
Excerpt:
PR was observed in 4 pts (20%) and SD (at any time point) was seen in 8 pts (40%). The CBR was 30% (n=6). The duration of response was 15.0 weeks (95% CI 4.9 - 16.1). The median TTF was 11.9 weeks (95% CI 7.5 - 21.1). The median PFS was 3.0 mo (95% CI 0.2 - 5.8) and OS was 14.0 mo (95% CI 5.2-22.8)....The combination of Copanlisib and Trastuzumab is a safe and tolerable regimen and is associated with clinical efficacy in a heavily pre-treated metastatic HER2positive breast cancer population.
Source:
Title:
Phase Ib Trial of Copanlisib, A Phosphoinositide-3 Kinase (PI3K) Inhibitor, with Trastuzumab in Advanced Pre-Treated HER2-Positive Breast Cancer "PantHER"
Published date:
03/11/2021
Excerpt:
Patients with advanced HER2-positive breast cancer and disease progression following at least one prior line of HER2 therapy in the metastatic setting were treated with copanlisib (45 or 60 mg) IV on days 1, 8 and 15 of a 28-day cycle with a fixed dose of trastuzumab 2 mg/kg weekly...Preliminary evidence of tumour stability was observed in patients with heavily pre-treated, metastatic HER2 positive breast cancer.
DOI:
10.3390/cancers13061225
Trial ID:
Source:
Title:
A phase Ib trial of copanlisib and tratuzumab in pretreated recurrent or metastatic HER2-positive breast cancer “PantHER.
Published date:
05/16/2018
Excerpt:
...safety of C + T were evaluated in an open label, single arm, adaptive multicenter phase Ib dose escalation clinical trial in patients (pts) with HER-2 positive BC….Best response was stable disease in 9/12 pts and 6 pts continued treatment ≥16 weeks....C+T is a safe, well tolerated combination.
DOI:
10.1200/JCO.2018.36.15_suppl.1036
Trial ID:
