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Association details:
Biomarker:ER positive
Cancer:HER2 Negative Breast Cancer
Drug:everolimus (mTOR inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

A randomized controlled trial for Neoadjuvant Everolimus Plus EC followed by T Compared With EC followed by T in patients with ER-positive, HER2-negative operable breast cancer

Excerpt:
...No distant metastasis by histological diagnosis of histological grade level III of invasive breast cancer patients (T > 2 cm, or any T and histological diagnosis of metastatic axillary lymph node > 2 cm), tumor molecular diagnosis of ER positive immunohistochemical study (ER positive percentage of 10% or higher), her2-negative (HER2 immunohistochemical staining 0 or 1 + or fluorescence in situ hybridization FISH -); 3. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:

Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women

Excerpt:
...Histological or cytological confirmation of estrogen-receptor positive (ER+), HER2 negative breast cancer....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Safety and Efficacy of RAD001 (Everolimus) Administered Upon Relapse During or After Adjuvant Treatment in Post-menopausal Women With Hormone Receptor Positive, HER2/neu Negative Locally Advanced or Metastatic Breast Cancer (CRAD001JGR08 “MELPOMENI” study)

Published date:
02/01/2022
Excerpt:
This study aimed to provide real-world safety and effectiveness data of everolimus (EVE) plus exemestane (EXE) in estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced breast cancer (aBC)….Over a median (interquartile range) of 12.1 months (range=4.2-20.5 months) of EVE treatment, the median progression-free survival was 18.0 months and the overall response rate was 22.7%.
Secondary therapy:
exemestane
DOI:
https://doi.org/10.21873/anticanres.15564
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

238P - BOLERO-5: A phase II study of everolimus and exemestane combination in Chinese post-menopausal women with ER+/HER2- advanced breast cancer

Published date:
09/13/2021
Excerpt:
The results of the global BOLERO-2 trial established the efficacy and safety of combination everolimus (EVE, an mTOR inhibitor) and exemestane (EXE) in the treatment of ER+, HER2-, locally advanced, recurrent, or metastatic breast cancer (ABC). BOLERO-5 investigated this combination in Chinese post-menopausal women with ER+, HER2- ABC….Treatment with EVE + EXE improved ORR (8.8% [90% CI, 4.2, 15.8] vs 1.3% [90% CI, 0.1, 5.9]) and CBR (35.0% [90% CI, 26.1, 44.7] vs 16.5% [90% CI, 10.0, 24.9]).
Secondary therapy:
exemestane
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Neoadjuvant everolimus plus letrozole versus fluorouracil, epirubicin and cyclophosphamide for ER-positive, HER2-negative breast cancer: a randomized pilot trial

Published date:
07/27/2021
Excerpt:
Completion rate was 90.0% in the neoadjuvant endocrine therapy (NET) arm but 70.0% in the neoadjuvant chemotherapy (NAC) arm. The ultrasound response rate was 65.0% in NET arm and 40.0% in FEC arm, respectively. neoadjuvant everolimus plus letrozole might achieve a favorable ultrasound response rate with low toxicities in treating postmenopausal ER-positive, HER2-negative breast cancer patients. Everolimus plus letrozole might have positive antitumoral immunity effects.
Secondary therapy:
letrozole
DOI:
10.1186/s12885-021-08612-y
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Everolimus plus endocrine vs endocrine therapy in treatment advanced ER+, HER2- breast cancer patients: A meta-analysis

Published date:
04/01/2019
Excerpt:
Everolimus increased the efficacy of endocrine therapy in treatment advanced endocrine receptor-positive, human epidermal growth factor 2 negative breast cancer patients, and the safety profile of the combination is acceptable.
DOI:
10.1016/j.currproblcancer.2018.08.009
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Everolimus (EVE) + exemestane (EXE) vs EVE alone or capecitabine (CAP) for estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): BOLERO-6, an open-label phase 2 study. Add to Collection

Published date:
05/16/2018
Excerpt:
The estimated HR of PFS for EVE + EXE vs EVE (0.74) is indicative of a treatment benefit. While the estimated HR of PFS for EVE + EXE vs CAP was 1.26, the CAP arm may have been favored by baseline imbalances and potential informative censoring. The safety profile of EVE + EXE was consistent with the known profile of this combination.
Secondary therapy:
exemestane
Trial ID: