Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Fulvestrant

Exemestane

Letrozole

Anastrozole

Aromatase Inhibitors

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

LOXO-783 administered orally in combination with fulvestrant intramuscularly, imlunestrant orally, or an aromatase inhibitor orally

LOXO-783 orally in combination with abemaciclib and either physician's choice aromatase inhibitor orally, fulvestrant intramuscularly, or imlunestrant orally

LOXO-783 orally in combination with fulvestrant intramuscularly

LOXO-783 orally in combination with paclitaxel intravenously

Multiple randomized dose levels of LOXO-783 orally with fulvestrant intramuscularly

LOXO-783

Imlunestrant

Abemaciclib

Anastrozole, Exemestane, or Letrozole

Patient Advocacy

Vincent Chau, MD; PhD

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

Number of patients with DLT-equivalent toxicities

ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)

Loxo Oncology, Inc.

Eli Lilly and Company

Symptoms and General Pathology

Recurrence

Bone Density Conservation Agents

Tamoxifen

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.

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

Michael Meshad

Marshall Schreeder

Thaddeus A Beeker

Shakeela W Bahadur

Govardhanan Nagaiah

Albert Guy Wendt

Brenda Ernst

Aisha Ahmed

Sima Ehsani

Joseph Beck

Hope S Rugo

Gayathri Nagaraj

Parminder Sidhu

Michael Zachary Koontz

Stavroula Otis

Ritesh Parajuli

Mili Arora

Helen Moon

Ajithkumar Puthillath

Elena Elena Shagisultanova

Uchenna Okagbue Njiaju

Chelsea D Gawryletz

Esther Mondo

Ling Ma

Maryam B Lustberg

Christopher Michael Gallagher

Wassim Mchayleh

Karim Arnaout

Delia Guaqueta

Isaac Levy

Kostandinos Sideras

Naomi Dempsey

Pavan Kancharla

Michael Poiesz

Jamie Erin McKenzie

Manali Bhave

Amelia Zelnak

Priyanka Raval

Mark Taylor

Jennifer F. Carney

Jami Fukui

Karl Schultheiss

William Gradishar

Abiola Abiola Ibraheem

Nadia Rehman

Krishna A Rao

Jaswinder Singh

Qamar Khan

Pavani Ellipeddi

Melanie Sheen

David Oubre

Shibu Varughese

Nicholette Erickson

Marilyn McLaughlin

Jeremy Perkins

Seth Wander

Rinath Jeselsohn

Sonia Seng

Natalie Sinclair

Pedro Manuel Sanz-Altamira

Aron Rosenstock

James Hart Stoeckle

Madhavi Toke

Kiran Lassi

Timothy Larson

Amy Kathryn Krie

Karthik Giridhar

Christos Papageorgiou

Ashley Frith

Katherine Clifton

Kirsten Leu

Mary D. Chamberlin

Jeanna Walsh

E Walzer

Bruno Fang

Deena M. Graham

iuliana Shapira

Mridula Annette George

Erica Linden

Katherine Sanchez

Jacklyn Nemunaitis

Karen Tedesco

Abhigna Kodali

Pooja Murthy

Ruby Sharma

Nancy Chan

Komal Jhaveri

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 main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence

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.

IDFS excluding second non-breast primary invasive cancers

PK: steady state plasma concentrations of imlunestrant

The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess multidimensional quality of life (QOL) in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Physical functioning was measured by items 1 to 5. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).

The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Role functioning was measured by items 6 and 7. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).

The EORTC QLQ-C30 is a 30-question patient reported instrument used to assess the multidimensional QOL in cancer patients. It consists of 15 domains: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). Global QOL was measured by items 29 and 30. The sum score was linearly transformed to the range 0 - 100 as recommended by the EORTC (higher score is better).

FACT GP5 = Functional Assessment of Cancer Therapy - General Physical Well-being Item 5 (FACT GP5). High overall adverse event burden is defined as a score of 3 or 4 on a 5-point Likert scale. Higher scores represent higher symptom burden.

Neoplasm Metastasis

Neoplastic Processes

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

Imlunestrant plus abemaciclib administered orally.

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

PFS by investigator assessment in the IIT population

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors	NCT05307705	Breast Cancer	LOXO-783 Fulvestrant Imlunestrant Abemaciclib Anastrozole, Ex... Paclitaxel	18 Years -	Eli Lilly and Company
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer	NCT05514054	Breast Neoplasm...	Imlunestrant Tamoxifen Anastrozole Letrozole Exemestane	18 Years -	Eli Lilly and Company
A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors	NCT05307705	Breast Cancer	LOXO-783 Fulvestrant Imlunestrant Abemaciclib Anastrozole, Ex... Paclitaxel	18 Years -	Eli Lilly and Company
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

Spots Global Cancer Trial Database for imlunestrant

Every month we try and update this database with for imlunestrant 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.