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Table 3 Clinical trials cancers for treatment of patients with PTEN-deficient. Tables and data are adopted from clinicaltrials.gov. (https://clinicaltrials.gov/)

From: Recent advances of therapeutic targets based on the molecular signature in breast cancer: genetic mutations and implications for current treatment paradigms

Status of trial

Conditions

Interventions of clinical trial

Study type

Study completion time

Recruiting

• PTEN mutation and PTEN hamartoma Tumor Syndrome (PHTS)

• Drug: RAD001 and placebo

Interventional, phases 1 and 2

2019

Recruiting

• Advanced solid tumors with PTEN or PIK3CB mutations

• Anatomic stage III BC AJCC v8 and anatomic stage IIIA BC AJCC

• Drug: Docetaxel, PI3Kbeta and AZD8186 inhibitor

• Biomarker evaluation

Interventional, phase 1

2021

Completed

• Cowden’s disease

• PHTS

• Fludeoxyglucose F 18 as radiotherapy

• Drug: Sirolimus

Interventional, phase 2

2012

Recruiting

• Cancer and solid tumors with AKT1, 2, 3 genetic changes, activating PI3K mutations, PTEN mutations

• Drug: ARQ 751

Interventional, phase 1

2019

Active, not recruiting

• Advanced cancers with PI3KCA mutation, Positive/PTEN under-expression

• Drug: Pazopanib and Everolimus

Interventional, phase 1

–

Not yet recruiting

• Metastatic BC with AR+ and PTEN+

• Drug: Alpelisib (BYL719), and Enzalutamide (androgen receptor inhibitor)

Interventional, phase 1

2021

Completed

• Evaluation of tumor suppressor gene PTEN endometrial neoplasms

• Behavioral: questionnaire

• DNA testing/tumor-genetic markers

Observational study

2011

Terminated

• c-MET inhibitor; PI3K inhibitor, PTEN mutations, homozygous del. PTEN neg.

• Drug: INC280 and Buparlisib

Interventional, phases 1 and 2

23, 2016

Recruiting

• Metastatic melanoma and PTEN loss, malignancy of skin

• Metastatic melanoma

• Drug: GSK2636771 and Pembrolizumab

Interventional, phases 1 and 2

2021

Recruiting

• Carcinoma, squamous cell of head and neck with PI3KCA mutation and/or PTEN under-expression

• Drug: Copanlisib and Cetuximab

Interventional, phases 1 and 2

2020

Completed

• Advanced solid tumors with PTEN deficiency

• Drug: GSK2636771

Interventional, phase 2

2016

Recruiting

• Advanced cancers with somatic mutation in BRCA1/2

• Mutations/or deletions in PTEN /or PTEN under-expression

• Drug: Talazoparib Tosylate

Interventional, phase 2

2020

Recruiting

• BC with PIK3CA/AKT1/PTEN-alteration

• TNBC

• Drug: Ipatasertib, paclitaxel and placebo

Interventional, phases 1 and 2

2021