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Association details:
Evidence:
Evidence Level:
Resistant: B - Late Trials
Title:

PIK3CA mutation in the ShortHER randomized adjuvant trial for patients with early HER2+ breast cancer: association with prognosis and integration with PAM50 subtype

Published date:
08/25/2020
Excerpt:
The ShortHER trial randomized 1253 patients with HER2-positive breast cancer to 9-weeks or 1-year of adjuvant trastuzumab combined with chemotherapy. A mutation of the PIK3CA gene was detected in 21.7% of the 803 genotyped tumors. At a median follow up of 7.7 years, 5-yr disease-free survival (DFS) rates were 90.6% for PIK3CA mutated and 86.2% for PIK3CA wild-type tumors (HR 0.84, 95%CI 0.56-1.27, P=0.417).
DOI:
10.1158/1078-0432.CCR-20-1731
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Activity of trastuzumab based chemotherapy in metastatic breast patients with HER2-negative primary tumor but HER2 positive circulating tumor cells (CareMore-Trastuzumab)

Excerpt:
...Secondary endpoints are the association between 6 months PFR and PIK3CA mutation status, pHER2 expression and ER expression on CTC's. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

Excerpt:
...The alteration rate of the PI3K pathway is the percentage of participants having either PTEN loss or a PIK3CA mutation. ...
Less C2 evidence
Evidence Level:
Resistant: C3 – Early Trials
Title:

Baseline Mutations and Up-Regulation of PI3K-AKT Pathway Serve as Potential Indicators of Lack of Response to Neoadjuvant Chemotherapy in Stage II/III Breast Cancer

Published date:
04/04/2022
Excerpt:
We prospectively studied stage II/III BC patients who were eligible for breast-conserving surgery. Patients received epirubicin and cyclophosphamide for 4 cycles, followed by another 4-cycle docetaxel, and human epidermal growth factor receptor (HER2) positive patients were additionally treated with herceptin when using docetaxel (EC-T(H))....PIK3CA (48%) and TP53 (40%) mutations were enriched in patients not achieving pCR.
Secondary therapy:
docetaxel + cyclophosphamide + epirubicin
DOI:
10.3389/fonc.2021.784985
Evidence Level:
Resistant: C3 – Early Trials
Title:

Large-scale genomic sequencing reveals adaptive opportunity of targeting mutated-PI3Ka in early and advanced HER2-positive breast cancer

Published date:
11/04/2021
Excerpt:
CONTRADICTING EVIDENCE: ....patients harbouring mutated-PI3Kα exhibited a higher progressive disease rate (100% vs. 15%, p = .000053) and a lower objective response rate (81.7% vs. 95.4%, p = .0008) in response to trastuzumab-based therapy.... PIK3CA functional mutations suppressed the growth of HER2+ cells, but conferred anti-HER2 resistance, which can be reversed by the PI3Kα-specific inhibitor BYL719.
DOI:
10.1002/ctm2.589