Floatz logo
Floatz Rating
BB69/100
Confidence
Indicative
v0.2Rating updated July 14, 2026
Sponsor
UNC Lineberger Comprehensive Cancer Center
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2

Clinical Evidence

Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
72High confidence
Detailed axis rationale is planned and will be published soon.
TrialPhaseStatusNPrimary endpointReadout
Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies
Recruiting
Adjuvant Intensification for LAR
Not Yet Recruiting
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
Recruiting
A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
Recruiting
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
Recruiting
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
Recruiting
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
Recruiting
A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Breast Cancer (SIMRISE)
Recruiting
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
Recruiting
Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping
Not Yet Recruiting
Show 84 more trials
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment
Active Not Recruiting
Everolimus With Investigator's Choice of Chemotherapy in Advanced Triple-Negative Breast Cancer (TNBC) With Luminal Androgen Receptor (LAR) Subtype
Recruiting
Efficacy of Everolimus Combined With First-line Endocrine Therapy for HR+/HER2- SNF1-subtype Advanced Breast Cancer
Recruiting
Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer
Recruiting
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer
Active Not Recruiting
Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer
Withdrawn
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
Active Not Recruiting
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
Recruiting
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
Recruiting
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
Completed
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Recruiting
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
Active Not Recruiting
Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
Terminated
A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults
Unknown
AZD9833 China PK Study
Completed
Biology Guided Therapy for Breast Cancer for ER Positive
Terminated
The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy
Unknown
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer
Unknown
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
Terminated
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer
Active Not Recruiting
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
Terminated
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
Completed
Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast
Completed
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
Completed
A Trial of Neoadjuvant Everolimus Plus Letrozole Versus FEC in Women With ER-positive, HER2-negative Breast Cancer
Completed
Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer
Completed
Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
Unknown
Dried Blood SPOT Analysis of Everolimus in Cancer Patients (SPOT-study)
Completed
Dose EScalation Induction of EvERolimus
Completed
Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCT
Completed
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
Completed
Everolimus Combined With Anti-estrogen Therapy in Hormone-Receptor-Positive HER-2 Negative Advanced Breast Cancer
Completed
Everolimus trIal for Advanced prememopausaL Breast Cancer Patients
Unknown
Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score
Terminated
Phase II Study of Everolimus Beyond Progression
Terminated
Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer
Terminated
Patient Preference for Everolimus in Combination With Exemestane or Capecitabine in Combination With Bevacizumab
Completed
Maintenance Aromatase Inhibitors (AIs)+ Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients
Completed
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
Completed
Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer
Completed
S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer
Terminated
Analysis of Tumor Tissue and Circulating Genetic Material in the Blood to Obtain Further Insight in the Effectiveness of Everolimus When Combined With Exemestane
Unknown
Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women
Completed
Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer
Completed
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
Completed
S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer
Active Not Recruiting
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Completed
Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer
Terminated
NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer
Completed
Everolimus Beyond Progress for Patients Who Had Progress Under Everolimus and Exemestane
Terminated
Phase 1b/2 Trial Using Lapatinib, Everolimus and Capecitabine for Treatment of HER-2 Positive Breast Cancer With CNS Metastasis
Completed
Study of Fulvestrant +/- Everolimus in Post-Menopausal, Hormone-Receptor + Metastatic Breast Ca Resistant to AI
Completed
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
Completed
Exemestane-RAD001-Metformin
Terminated
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer
Completed
Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors
Completed
Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Completed
Lapatinib and RAD-001 for HER2 Positive Metastatic Breast Cancer
Unknown
A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer
Terminated
RAD001 Plus Carboplatin in Breast Cancer Patients
Completed
Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer
Completed
Daily Everolimus in Combination With Trastuzumab and Vinorelbine in HER2/Neu Positive Women With Locally Advanced or Metastatic Breast Cancer
Completed
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer
Completed
Phase I/II Study of Weekly Abraxane and RAD001 in Women With Locally Adv. or Metastatic Breast Ca
Terminated
Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer
Completed
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole
Completed
Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer
Completed
Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer
Completed
Trial of RAD001 in Triple Negative Metastatic Breast Cancer
Terminated
Everolimus (RAD001) and Carboplatin in Pretreated Metastatic Breast Cancer
Unknown
Everolimus in Treating Women With Breast Cancer That Can Be Removed by Surgery
Withdrawn
Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer
Completed
Trastuzumab With or Without Everolimus in Treating Women With Breast Cancer That Can Be Removed By Surgery
Terminated
Study of Combined Fulvestrant and Everolimus in Advanced/Metastatic Breast Cancer After Aromatase Inhibitor Failure
Completed
Bevacizumab, Everolimus (RAD001), and Lapatinib as Neoadjuvant Chemotherapy Regimes for Primary Breast Cancer
Completed
Phase I Oral mTOR Inhibitor RAD001 in Combo w/ Capecitabine for Metastatic Breast
Terminated
Efficacy and Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer
Completed
Paclitaxel Followed by FEC Versus Paclitaxel and RAD001 Followed by FEC In Women With Breast Cancer
Unknown
Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
Completed
Efficacy of RAD001 in Breast Cancer Patients With Bone Metastases
Unknown
Trastuzumab and RAD001 in Patients With Human Epidermal Growth Receptor 2 (HER-2) Overexpressing Breast Cancer
Completed
Erlotinib and Everolimus in Treating Patients With Metastatic Breast Cancer
Completed
RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Terminated
Everolimus in Treating Patients WIth Recurrent or Metastatic Breast Cancer
Completed

Competitive Position

Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.

Same indication · Breast Cancer

AssetSponsorPhaseRating
Everolimus (this asset)UNC Lineberger Comprehensive Cancer CenterApprovedBB · 69
PertuzumabSWOG Cancer Research NetworkP4BB
Vitamin DUniversity of Illinois at ChicagoP4BB
Eribulin MonomethanesulfonateHenan Cancer HospitalP4BB
PalbociclibHoffmann-La RocheP4BB
TamoxifenDana-Farber Cancer InstituteP4BB
AdriamycinGeorge Washington UniversityP4BB
GoserelinTerSera Therapeutics LLCP4BB
Peg-Rhg-CsfThe First Affiliated Hospital with Nanjing Medical UniversityP4BB

+42 more in the Breast Cancer cohort

Other indications for Everolimus

IndicationSponsorPhaseRating
Tuberous SclerosisP3BBB · 73
Hormone Receptor-Positive Breast CancerP4BBB · 72
Renal Cell CarcinomaP4BB · 70

Scientific Foundation

Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR

Planned for methodology v0.2.

Development Feasibility

How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR

Planned for methodology v0.2.

Commercial Opportunity

Commercial prize: addressable population, unmet need, and the value case for the indication.
NR

Planned for methodology v0.2.

IP & Exclusivity

Exclusivity position, covering patent protection and freedom-to-operate runway.
NR

Planned for methodology v0.2.

Manufacturing & Supply

Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR

Planned for methodology v0.2.

Related assets

Citation

Floatz Terminal. Everolimus in Breast Cancer. Methodology v0.2.
Rated under v0.2 effective July 8, 2026. Last refreshed July 14, 2026.
Accessed July 15, 2026.
https://terminal.floatz.ai/assets/everolimus-breast-cancer

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