Endocrine Therapy

Phase 3Small molecule

Eli Lilly

Endocrine Therapy is one of 50 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerCompleted

Endocrine TherapyActive, not recruiting

Adjuvant TherapyNot yet recruiting

HER2-Negative Metastatic Breast CancerNot yet recruiting

Ductal CarcinomaRecruiting

Breast CancerPhase 3

Completed

Endocrine TherapyPhase 3

Active, not recruiting

Adjuvant TherapyPhase 2

Not yet recruiting

HER2-Negative Metastatic Breast CancerPhase 2

Not yet recruiting

Ductal CarcinomaPhase 2

Recruiting

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Endocrine Therapy

Eli Lilly

Phase 3

34 2

Adenocard

Astellas

Preclinical

2 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Duragesic

CCephalon

Preclinical

1 5

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 6

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 7

Bisphosphonate

Amgen

Preclinical

2 8

4SCAR T Cells

SShenzhen Geno-Immune Medical Institute

Preclinical

1 9

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 10

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Breast Cancer

NCT02057133

Q1 2027

PreclinicalRecruiting

Breast Cancer

NCT07708194

Phase 2Recruiting

HER2-Positive Breast Cancer

NCT05306041

Phase 2Active, not recruiting

Breast Cancer

NCT03573648

Q3 2027

Phase 2Not yet recruiting

Breast Cancer

NCT04301375

Phase 2Recruiting

Breast Cancer

NCT05983107

Clinical

Trials by Indication[1]

Breast Cancer34 trials

Tucidinostat Combined With Metronomic Capecitabine and Endocrine Therapy for Advanced HR-positive, HER2-negative Breast Cancer After CDK4/6 Inhibitor.

Unknown status·Wwang shusen·Phase 2·NCT05411380·73 enrolled

CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)

Recruiting·FFudan University·Phase 3·NCT07019363·1,903 enrolled

Survival Endpoints in Women Treated for Metastatic Breast Cancer: Contribution of Real-life Databases

Completed·IInstitut Bergonié··NCT03676257·20,033 enrolled

Show 31 more trials

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

Recruiting·NNRG Oncology·Phase 3·NCT04852887·1,670 enrolled

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 2·NCT06341894·1,163 enrolled

Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer

Not yet recruiting·FFudan University·Phase 3·NCT07005557·1,244 enrolled

Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase (CDK) 4/6-inhibitors in Older Breast Cancer Patients

Recruiting·RRegion Örebro County·Phase 3·NCT06044623·495 enrolled

Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer

Terminated·—·N/A·NCT01897441·31 enrolled

Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti- HER2-based Neoadjuvant Therapy (ELPIS Trial)

Not yet recruiting·DDavid Garcia Cinca·Phase 2·NCT04301375·27 enrolled

PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)

Completed·MMedSIR·Phase 2·NCT03809988·198 enrolled

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT02057133·198 enrolled

A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT03955939·5 enrolled

Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Completed·KKyoto Breast Cancer Research Network·Phase 3·NCT03969121·141 enrolled

Current Status of Treatment for Chinese Patients With ESR1-mutated HR+/HER2-advanced Breast Cancer

Recruiting·SSciClone Pharmaceuticals··NCT06548919·450 enrolled

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04109066·521 enrolled

Chidamide/Everolimus for PIK3CA Wild-type/Mutant HR+/HER2- Advanced Breast Cancer

Recruiting·—·Phase 2·NCT05983107·102 enrolled

PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive Early Breast Cancer

Completed·SSOLTI Breast Cancer Research Group·Phase 2·NCT01973660·151 enrolled

Comparative Study for the Degree of Biological Changes After Short-term 2 Weeks and 4 Weeks Preoperative Endocrine Therapy in Luminal Breast Cancer

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT04023292·185 enrolled

MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.

Completed·MMerus B.V.·Phase 2·NCT03321981·105 enrolled

Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer

Unknown status·ZZhejiang Cancer Hospital·Phase 2·NCT03204734·132 enrolled

SWOG-8814 Tamoxifen With or Without Combination Chemotherapy in Postmenopausal Women Who Have Undergone Surgery for Breast Cancer

Completed·SSWOG Cancer Research Network·Phase 3·NCT00929591·1,558 enrolled

Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan

Completed· Pfizer logo

Pfizer··NCT05399329·688 enrolled

Effect of Surgery, Radiation Therapy, Chemotherapy, and Hormone Therapy on Biomarkers in Women With Stage I, Stage II, Stage III Breast Cancer, or Ductal Carcinoma In Situ That Can Be Removed By Surgery

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins··NCT00373191·35 enrolled

Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer

Completed·SSOLTI Breast Cancer Research Group·Phase 2·NCT02448420·73 enrolled

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT03725059·1,240 enrolled

MRI and Gene Expression in Diagnosing Patients With Ductal Breast Cancer In Situ

Active, not recruiting·EECOG-ACRIN Cancer Research Group·N/A·NCT02352883·368 enrolled

Neo-RT: Pre-operative Breast Intensity Modulated Radiotherapy in Patients Receiving Neo-adjuvant Hormonal Treatment for Breast Cancer - a Feasibility Study.

Active, not recruiting·CCCTU- Cancer Theme··NCT03818100·43 enrolled

A Phase III Randomized Controlled Trial Comparing Dalpicilib-Enhanced Adjuvant Endocrine Therapy With Standard Adjuvant Endocrine Therapy in ER+ HER2- Lymph Node-Negative Early Breast Cancer With Risk Factors

Recruiting·FFudan University·Phase 3·NCT06637150·1,388 enrolled

Single-Dose Stereotactic Radiosurgery (SDRT) as Definitive Non-Operative Treatment for Early-Stage Breast Cancer: A Prospective Single-Arm Pilot Trial With Bayesian Safety Monitoring (SOLIS / Protocol RAD 2024)

Not yet recruiting·RRenaissance Institute of Precision Oncology and Radiosurgery·Preclinical·NCT07844759·30 enrolled

A Pilot Study of IMMUNe mOdulation in Early Stage Estrogen Receptor Positive Breast Cancer Treated With neoADjuvant Avelumab, Palbociclib, and Endocrine Therapy: The ImmunoADAPT Study

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03573648·33 enrolled

A Prospective, Open-Label, Single-Arm Phase II Clinical Trial to Explore Chemotherapy Exemption in Elderly Women Aged 65 Years or Older With Lymph Node-Positive ER+/HER2- Breast Cancer

Not yet recruiting·FFudan University·Phase 2·NCT07826052·494 enrolled

Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer: A Single-arm, Prospective Clinical Trial

Recruiting·XXijing Hospital·Phase 2·NCT06914440·27 enrolled

An Open-Label, Single-Center, Exploratory Phase Ib/II Clinical Study of Entinostat Combined With Pyrotinib Plus Endocrine Therapy in Patients With Advanced Triple-Positive Breast Cancer After Trastuzumab Failure

Recruiting·TTianjin Medical University Cancer Institute and Hospital·Preclinical·NCT07708194·94 enrolled

Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS): A Randomized Phase II Study of Palbociclib With Letrozole Versus Letrozole Alone for Invasive Lobular Carcinoma and Invasive Ductal Carcinoma

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT02764541·195 enrolled