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Association details:
Biomarker:HR positive
Cancer:HER2 Negative Breast Cancer
Drug:everolimus (mTOR inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Excerpt:
Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer, in combination with exemestane...
Secondary therapy:
exemestane
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Excerpt:
AFINITOR is a kinase inhibitor indicated for the treatment of:...Postmenopausal women with advanced hormone receptor-positive, HER2­ negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.
Secondary therapy:
exemestane
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Excerpt:
HER2 Negative Breast Cancer: Invasive Breast Cancer…SYSTEMIC THERAPY FOR ER - AND/OR PR - POSITIVE RECURRENT OR STAGE IV (M1) DISEASE…HER2-Negative and Postmenopausal or Premenopausal Receiving Ovarian Ablation or Suppression…Preferred Regimens...Everolimus + endocrine therapy (exemestane, fulvestrant, tamoxifen)
Secondary therapy:
exemestane; fulvestrant; tamoxifen
Evidence Level:
Sensitive: A2 - Guideline
New
Source:
Title:

ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer

Excerpt:
A proposed treatment algorithm for the management of hormone receptor (HR)-positive, HER2-negative MBC...Recommendations...Second-line treatment...Everolimus/exemestane is an option since it significantly prolongs PFS...
Secondary therapy:
exemestane
DOI:
https://doi.org/10.1016/j.annonc.2021.09.019.
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

307P - Real-world evidence of CDK4/6 Inhibitor combination effects on assessing outcome with different sequence of treatment among adult patients with HR + and HER2 - metastatic breast cancer

Published date:
09/14/2020
Excerpt:
≥18 years with HR +, HER2 - MBC were classified into the following cohorts (Cs) based on different sequential use of drugs: C1: Hormonal therapy as First line therapy (FLT) followed by CDK 4/6i combinations, Everolimus combinations (EC) and Chemotherapy (CT) C2: CDK 4/6i combinations as FLT followed by EC and CT;...Test of proportions generated statistically significant results between C1&C2 showing that more patients tend to survive longer when they receive CDK4/6i combinations as FLT (C2 80% vs. C1 87%).
Secondary therapy:
CDK6 inhibitor; CDK4 inhibitor
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer

Excerpt:
...- Postmenopausal advanced hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer after failure of treatment with letrozole or anastrozole...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score

Excerpt:
...- Patients must have a histologically confirmed diagnosis of hormone receptor positive, HER2 negative invasive breast carcinoma....
Trial ID:
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy

Excerpt:
...ER+ and HER2 negative : Hormone receptor positive is defined as any staining on the primary tumor, HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH non-amplified] 6....
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of the Impact of Everolimus Treatment on Lymphocytes NK (Natural Killer) Development and Functions for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)

Excerpt:
...- Metastatic breast cancer HR+ (Hormone Receptor positive), HER2/neu negative (Human Epidermal Growth Factor Receptor-2)...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Everolimus TDM to Predict Long Term Toxicity

Excerpt:
...- Patients currently treated with everolimus for any type of cancer, such as the EMA registered indications i.e. advanced (Hormone-Receptor [HR]-positive, HER2-negative) breast cancer, metastatic renal cell carcinoma (mRCC) or neuroendocrine tumour (NET) of pancreatic, gastrointestinal or lung origin....
Trial ID:
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Everolimus for Treating Hormone Receptor-positive Metastatic Breast Cancer Previously Treated With Cyclin-dependent Kinase 4/6 Inhibitors

Published date:
08/01/2022
Excerpt:
Thirteen patients who received everolimus as a post-treatment after CDK4/6 inhibitor therapy from December 2017 to July 2021 were retrospectively reviewed….The overall response rate and clinical benefit rate were 15.3% (2/13) and 46.2% (6/13), respectively....Considering there is a mechanism of resistance to CDK4/6 inhibitors, everolimus would be important as an effective post-treatment for HR+ or HER2-negative metastatic and recurrent breast cancers treated with CDK4/6 inhibitors in clinical settings.
DOI:
10.21873/anticanres.15885
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Real-Life Analysis of Efficacy and Safety of Everolimus Plus Exemestane in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor-2-Negative Metastatic Breast Cancer Patients: A Turkish Oncology Group (TOG) Study

Published date:
12/22/2021
Excerpt:
Overall, 204 HR+, HER2- MBC patients treated with EVE + EXE after progressing following prior endocrine treatment were included....The objective response rate, median PFS, and median OS were 33.4%, 8.9 months, and 23.4 months, respectively....Multivariate analysis revealed that negative progesterone receptor status was a significant determinant of poor treatment response (p = 0.035) and PFS (p = 0.024)....We confirmed the favorable efficacy and safety profile of EVE + EXE for HR+, HER - MBC patients.
Secondary therapy:
exemestane
DOI:
10.1080/07357907.2021.2017952
Evidence Level:
Sensitive: C3 – Early Trials
Title:

REAL-LIFE ANALYSIS OF EFFICACY AND SAFETY OF EVEROLIMUS PLUS EXEMESTANE IN HORMONE RECEPTOR-POSITIVE, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR-2- NEGATIVE METASTATIC BREAST CANCER PATIENTS: A TURKISH ONCOLOGY GROUP (TOG) STUDY

Published date:
12/11/2021
Excerpt:
The objective response rate, median PFS, and median OS were 33.4%, 8.9 months, and 23.4 months, respectively….We confirmed the favorable efficacy and safety profile of EVE + EXE for HR+, HER2- MBC patients.
Secondary therapy:
exemestane
DOI:
10.1080/07357907.2021.2017952
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Efficacy and safety of low-dose everolimus combined with endocrine drugs for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer

Published date:
10/01/2021
Excerpt:
Clinical data of hormone receptor (HR)-positive and HER2-negative patients with advanced breast cancer treated with everolimus combined with endocrine drugs...were retrospectively analyzed....the clinical benefit rate (CBR) was 31.8%, the median progression-free survival (mPFS) was 4.0 months (95% CI: 2.9-5.1 months), and the median overall survival (OS) was 17 months (95% CI: 12.1-21.9 months)....Our results showed that everolimus (5 mg/day) combined with endocrine therapy was effective and relatively safe for patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
DOI:
10.21037/atm-21-4273
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

LBA19 - A multicenter, randomized, double-blind, phase II study to evaluate the tolerability of an induction dose escalation of everolimus in patients with metastatic breast cancer (mBC) (DESIREE)

Published date:
09/13/2021
Excerpt:
DESIREE met its primary objective and showed that a dose escalation schema of everolimus over three weeks can be successfully used in pts with HR+/HER2- mBC to prevent the onset of mucositis G≥2 without affecting efficacy.
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Effectiveness of Adding Everolimus to the First-line Treatment of Advanced Breast Cancer in Premenopausal Women Who Experienced Disease Progression While Receiving Selective Estrogen Receptor Modulators: A Phase 2 Randomized Clinical Trial

Published date:
08/26/2021
Excerpt:
Patients receiving everolimus plus letrozole achieved a significantly longer median PFS compared with those receiving letrozole alone (19.4 months [95% CI, 16.3-22.0 months] vs 12.9 months [95% CI, 7.6-15.7 months]; hazard ratio, 0.64 [95% CI, 0.46-0.89]; P = .008)...PFS was significantly longer among premenopausal patients with HR-positive/ERBB2-negative advanced breast cancer who received everolimus plus letrozole than among those who received letrozole alone.
DOI:
10.1001/jamaoncol.2021.3428
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Everolimus and exemestane in hormone receptor-positive advanced breast cancer: A comprehensive cancer center’s experience.

Published date:
05/19/2021
Excerpt:
We retrospectively evaluated patients with HR+, HER2 negative ABC treated with everolimus/exemestane...Overall response rate was 14.3% (1 complete response and 8 partial responses)...Median PFS was 5.6 months (CI95% 2.4-8.8) and median OS was 25.4 months (CI95% 10.3 40.5)...Our results confirm the effectiveness and safety of everolimus/exemestane in real-world setting and support its use mainly before palliative ChT.
Secondary therapy:
exemestane
DOI:
10.1200/JCO.2021.39.15_suppl.e13017
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Everolimus combined with endocrine therapy in advanced HR-positive, HER2-negative Chinese breast cancer patients: A retrospective study. Add to Collection

Published date:
05/19/2021
Excerpt:
Everolimus combined with fulvestrant is not superior to everolimus combined with AI in HR-positive, HER2-negative breast cancer patients. For postmenopausal patients, patients without bone metastasis, and patients with visceral disease, everolimus combined with AI is a better choice.
Secondary therapy:
Aromatase inhibitor
DOI:
10.1200/JCO.2021.39.15_suppl.e13023
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Safety and efficacy of everolimus (EVE) plus exemestane (EXE) in postmenopausal women with locally advanced or metastatic breast cancer: final results from EVEREXES

Published date:
03/16/2021
Excerpt:
The EVEREXES trial initiated in 2012, provided early access to the first dual blockade treatment with EVE + EXE in patients with HR+, HER2 - ABC in Asia and other emerging growth countries…..Confirmed overall response rate (ORR) was achieved for 19.6% of the patients. Efficacy of EVE + EXE across subgroups (prior CT, line of treatment, and presence of visceral metastases) was maintained.
DOI:
10.1007/s10549-021-06173-z
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Patterns of treatment with everolimus exemestane in hormone receptor-positive HER2-negative metastatic breast cancer in the era of targeted therapy

Published date:
01/29/2021
Excerpt:
This study assesses the use and efficacy of everolimus exemestane in patients with metastatic HR+ HER2- breast cancer previously treated with endocrine therapy (ET) or endocrine therapy + CDK4/6i….This study suggests that EE remains an effective treatment option after prior ET or ET + CDK4/6i use. Median TTNT of EE was longer for patients who received prior ET, whereas median OS was longer for patients who received prior ET + CDK4/6i...EE remains an effective treatment option regardless of prior treatment option.
Secondary therapy:
exemestane
DOI:
10.1186/s13058-021-01394-y
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Use of Everolimus and Trastuzumab in Addition to Endocrine Therapy in Hormone-Refractory Metastatic Breast Cancer

Published date:
01/03/2019
Excerpt:
We hypothesized that the additional use of trastuzumab (T) or everolimus (E) could restore sensitivity to ET in patients with endocrine-resistant, HR-positive, HER2-negative MBC. These results suggest that E, but not T, can potentially reverse resistance to ET in patients with endocrine-resistant HR-positive, HER2-negative MBC.
DOI:
10.1016/j.clbc.2018.12.017
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Efficacy and safety of low-dose everolimus in Chinese HR-positive, HER2-negative metastatic breast cancer patients

Published date:
05/16/2018
Excerpt:
...68 HR+/HER2- MBC patients were included in this exploratory study who received everolimus at the dose of 5mg...PFS for the first and second-line is significantly longer than that for the third-line or later (12.9months vs. 4.6months, P= 0.009, HR = 0.395, 95% CI = 0.192-0.811). 11(16.2%) achieved partial response (PR), 42(61.7%) had stable disease (SD), and 15(22.1%) reported progressive disease (PD). The ORR and CBR were 16.2%, 35.2%, respectively.
DOI:
10.1200/JCO.2018.36.15_suppl.e13035
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Combined everolimus and endocrine therapy in advanced HR-positive, HER2-negative Chinese breast cancer patients: a retrospective study

Excerpt:
Furthermore, it showed EVE + AI was superior to EVE + FUL in some subgroups: postmenopausal group (hazard ratio, 0.50; 95% CI, 0.26-0.98); without bone metastasis group (hazard ratio, 0.22; 95% CI, 0.06-0.80); visceral disease group (hazard ratio, 0.37; 95% CI, 0.20-0.69). EVE combined with endocrine therapy is an effective treatment option for Chinese patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) breast cancer, although EVE + FUL was not superior to EVE + AI.
Secondary therapy:
Aromatase inhibitor
DOI:
10.21037/atm-21-3840
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

Efficacy of everolimus combined with endocrine therapy in HR-positive/HER-2-negativeadvanced breast cancer

Excerpt:
Everolimus combined with endocrine therapy has significant clinical efficacy in patients with HR-positive/HER-2-negative advanced breast cancer, and can effectively improve the survival of patients with tolerable adverse reactions.
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Case report: 5-year progression free survival and complete liver response in a patient with metastatic breast cancer treated with everolimus plus exemestane

Published date:
07/31/2020
Excerpt:
...patient affected by HR+ HER2- MBC...A third line treatment with Eve (10 mg once daily) plus Exe (25 mg once daily) was initiated. The disease started to respond after 4 months of treatment and the best response was obtained after 39 months of treatment reaching complete response of the liver disease...
Secondary therapy:
exemestane
DOI:
10.1097/MD.0000000000021211