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LY3484356

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.

A Study of LY3484356 in Women With Breast Cancer Before Having Surgery

EMBER-2: A Phase 1, Open-Label, Preoperative Window Study Evaluating the Biological Effects of LY3484356 in Post-menopausal Women With Stage I-III Estrogen Receptor-Positive, HER2-Negative Breast Cancer

ER expression measured by H-score immunohistochemistry (IHC)

Ki-67 index measured by percentage positive scoring by IHC

Eli Lilly and Company

Symptoms and General Pathology

Neoplasm Metastasis

Antineoplastic Agents

Anti-Infective Agents

Amino Acids

Antibodies

Capecitabine

Paclitaxel

Bevacizumab

Everolimus

Fulvestrant

Albumin-Bound Paclitaxel

Sirolimus

Immunoglobulins

Aromatase Inhibitors

Tyrosine Kinase Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Temsirolimus

MTOR Inhibitors

Androgen Receptor Antagonists

Fluzoparib

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Tyrosine

If a patient were NF1 mutated, she would receive SHR7390(MEK1/2 inhibitor) and Faminitib.

If a patient were gBRCA mutated, she would receive SHR3162 (PARP inhibitor)and SHR6390(CDK4/6 inhibitor) .

If a patient were HER2 activated mutated and had not previously used capecitabine, she would receive Pyrotinib and Capecitabine , while if the patient have previously used capecitabine, she would only use pyrotinib as a single agent.

If a patient were PDGFRb mutated, she would receive Faminitib.

In the arm which IHC showed CD8 ≥10%, this arm will be subdivided into 6 sub-arms, in which Arm 5A-4D, we choose the patients who had CDK4/6 inhibitor before while in Arm 5E, we choose the patients who secondarily resistant to adjuvant endocrine therapy , and in Arm 5FF, we choose the patients who is in stage IV without precious treatment or sensitively recurrence. A patient would receive SHR1210(PD-1 antibody) ,nab-paclitaxel and Faminitib in Arm-5A. A patient would receive SHR1210(PD-1 antibody) and VEGF inhibitor in Arm-5B. A patient would receive SHR1701(PD-L1/TGF-βRII inhibitor) in Arm-5C. A patient would receive SHR1701(PD-L1/TGF-βRII inhibitor) and SHR6390(CDK4/6 inhibitor) in Arm-5D. A patient would receive SHR1210(PD-1 antibody) and SHR6390(CDK4/6 inhibitor) and SERD in Arm-5E. A patient would receive SHR1210(PD-1 antibody) and SHR6390(CDK4/6 inhibitor) and AI in Arm-5F.

If a patient had any PAM pathway mutation, she would receive Everolimus(mTOR inhibitor) combined with nab-paclitaxel.

If a patient's IHC showed AR≥10% , she would receive SHR2554(EZH2 inhibitor) and SHR3680(AR inhibitor).

In this cohort, a patient would receive SHR2554(EZH2 inhibitor) and SHR3162 (PARP inhibitor).

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1701(anti-PD-L1/TGF-βRII bifunctional fusion protein) .

SHR7390

Famitinib

SHR3162

HER1 / HER2 receptor tyrosine kinase inhibitor

Pyrotinib

In Arm III, if the patient had not previously used capecitabine,she would receive pyrotinib and capecitabine, if the patients have previously used capecitabine, she would only used pyrotinib as a single agent.

SHR1210

Nab paclitaxel

SHR2554

SHR3680

SHR6390

anti-PD-L1/TGF-βRII bifunctional fusion protein

SHR1701

SERD

VEGFi

Zhi-Ming Shao

Zhong-Hua Wang

Zhimin Shao, MD, PhD

This study is a prospective, single-center, open-label, umbrella-shaped phase II clinical study for patients with HR+/HER2- endocrine-resistant advanced breast cancer.

Seven precision treatment cohorts, which targeting NF1 mutation, gBRCA mutation,HER2 mutation, FDGFRb mutation PAM pathway mutations, CD8 and AR, as long as an epigenetic therapy cohort and a combined immunization cohort were initially set up based on gene expression profiles and molecular pathways. The main purpose is to screen valuable treatment cohorts and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer

Precision Treatment of Luminal Advanced Breast Cancer Based on Molecular Subtyping

The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)

the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the evaluable subjects

time to progressive disease (according to RECIST1.1)

Fudan University

Professor, Key Laboratory of Breast Cancer in Shanghai, Department of Breast Surgery

Bone Density Conservation Agents

Tamoxifen

Patients will get LSZ102 single agent during dose escalation.

Patients will get LSZ102 in combination with LEE011 during dose escalation.

Patients will get LSZ102 in combination with BYL719 during dose escalation.

Patients will get LSZ102 single agent during dose expansion

Patients will get LSZ102 + LEE011 (LEE011 intermittent regimen) during dose expansion

Patients will get LSZ102 + LEE011 (LEE011 continuous regimen) during dose expansion

Patient will get LSZ102 in combination with BYL719 during dose expansion

LSZ102

LEE011

BYL719

Novartis Pharmaceuticals

To characterize the safety and tolerability, identify recommended doses and regimens for future studies, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of LSZ102 as a single agent and in combination with either LEE011 or BYL719 in adult patients with locally advanced or metastatic ER+ breast cancer who have progressed after endocrine therapy.

Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

A Phase I/Ib, Open Label Study of LSZ102 Single Agent and LSZ102 in Combination With Either LEE011 (LSZ102 + LEE011) or BYL719 (LSZ102 + BYL719) in Patients With Advanced or Metastatic ER+ Breast Cancer Who Have Progressed After Endocrine Therapy

The dose escalation part of the study will be guided by well-established statistical methods/models to estimate the maximum tolerated doses (MTD)and/or recommended doses for expansion (RDE). Safety, pharmacokinetic and pharmacodynamics data will guide dose escalation decisions.

Incidence and severity of adverse events, serious adverse events, clinical laboratory values, vital signs, ECGs, dose interruptions, dose reductions and dose intensity.

Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719. ORR is defined as the proportion of patients with a best overall response of complete response or partial response.

Assessment of preliminary anti-tumor activity of LSZ102, LSZ102 + LEE011 and LSZ102 + BYL719

Plasma concentration versus time under fasted and fed conditions

Cmax = Maximum observed plasma concentration after drug administration

Cmin = Minimum observed plasma concentration after drug administration

Neoplastic Processes

Exemestane

Antineoplastic Agents, Hormonal

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Investigator's choice of exemestane administered orally or fulvestrant administered intramuscularly (IM). See local approved label for additional instructions.

Imlunestrant plus abemaciclib administered orally.

Imlunestrant

Abemaciclib

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Gopal Kunta

Poornima Saha

Brian Dong

Natale T Sheehan

Richards Afonja

Lisa Carey

Sunitha Vemulapalli

Adnan R Alkhalili

SMO Sarah Cannon Research Inst.

Henna Malik

Monte Jones

SMO US Oncology

Wim Wynendaele

Stéphanie Henry

Ziyan Wang

Yongqiang Zhang

Zefei Jiang

Jian Liu

Yanxia Shi

XIAOPING LI

Qingyuan Zhang

Xinshuai Wang

Lina Liu

huihua xiong

chuang chen

Xinhong Wu

Tao Wu

Peizhi Fan

Juan Huang

Quchang Ouyang

Yongmei Yin

Hong Wang

Wei Li

Jingwei Xu

Jin Yang

Meili Sun

Changping Shan

Ping Sun

Hao Wang

Xujuan Wang

Zhongsheng Tong

Peifen Fu

Xian Wang

Xiaojia WANG

Xujun Li

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer

EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

PFS by investigator assessment in the IIT population

PFS by investigator assessment in ESR1-mutation detected population

OS in the ESR1-mutation detected population

Measured by the Worst Pain Numeric Rating Scale (NRS). NRS is a single item, participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "pain as bad as you can imagine."

PK: steady state plasma concentrations of imlunestrant

PK: steady state plasma concentrations of imlunestrant and abemaciclib

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with SHR1316 (anti-PD-L1) and endocrine therapy.

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with endocrine therapy.

In this cohort, a patient would receive SHR1316 (anti-PD-L1) combined with nab-paclitaxel.

In this cohort, a patient would single nab-paclitaxel.

In this cohort, a patient would receive SHR6390(CDK4/6 inhibitor) combined with fulvestrant.

SHR-1316

Min U He, M.D.

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Patients with SNF2 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. Five treatment arms were set up based on the whether they have exposed to CDK4/6 inhibitors before. The main purpose is to evaluate immune therapy in SNF2 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02

Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer

the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery	NCT04647487	Breast Cancer	LY3484356	18 Years -	Eli Lilly and Company
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery	NCT04647487	Breast Cancer	LY3484356	18 Years -	Eli Lilly and Company
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers	NCT02734615	Advanced or Met...	LSZ102 LEE011 BYL719	18 Years -	Novartis
Molecularly Targeted Umbrella Study in Luminal Advanced Breast Cancer	NCT04355858	Breast Cancer Metastatic Canc...	SHR7390 Famitinib SHR3162 Pyrotinib Capecitabine SHR1210 Everolimus Nab paclitaxel SHR2554 SHR3680 SHR6390 SHR1701 SERD AI VEGFi	18 Years - 75 Years	Fudan University
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer	NCT04975308	Breast Neoplasm... Neoplasm Metast...	Imlunestrant Exemestane Fulvestrant Abemaciclib	18 Years -	Eli Lilly and Company
Immune Therapy in HR-positive/HER2-negative Metastatic Breast Cancer(ENIGMA)-BCTOP-L-M02	NCT05205200	Breast Cancer Metastatic Canc...	SHR-1316 SHR6390 Nab paclitaxel SERD AI	18 Years - 75 Years	Fudan University

Spots Global Cancer Trial Database for serd

Every month we try and update this database with for serd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for serd

Every month we try and update this database with for serd cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for serd cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.