Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hormones

Exemestane

Letrozole

Durvalumab

Anastrozole

Aromatase Inhibitors

Antineoplastic Agents, Immunological

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Antineoplastic Agents, Hormonal

Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.

Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited.

1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

Anastrozole 1mg

Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

Letrozole 2.5mg

Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Exemestane 25 MG

Hung Khong, MD

This study is to find out if an investigational drug called Durvalumab (MEDI4736) given together with a standard of care aromatase inhibitor drug can help people with breast cancer.

Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer

A Phase II Trial With Safety Run-in of Neoadjuvant Therapy With an Aromatase Inhibitor in Combination With Durvalumab (MEDI4736) in Postmenopausal Patients With Hormone-Receptor-Positive Breast Cancer

Modified preoperative endocrine prognostic index (mPEPI) of 0. Total PEPI score assigned to each patient is the sum of the risk points derived from the pathological (pT) stage, lymph node (pN) stage, Ki67 level, and estrogen receptor (ER) status of the surgical specimen. A hazard ratio (HR) in the range of 1-2 receives one risk point; a HR in the 2-2.5 range, two risk points; a HR greater than 2.5, three risk points.

mPEPI score of 0 indicates a tumor size of 5 cm or less, negative lymph nodes, and Ki67 (proliferation index) of less than or equal to 2.7%. Drug combination will be determined to be efficacious if 7 or more participants achieve an mPEPI of 0.

Clinical Complete response: Palpable lesion(s) identified at baseline are no longer palpable and there are no new lesion(s) or other signs of disease progression.

Clinical Partial response: A reduction in the product of the two largest perpendicular diameters of the primary tumor by 50% or more.

AstraZeneca

H. Lee Moffitt Cancer Center and Research Institute

Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.

Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Safety Run In: Durvalumab + Aromatase Inhibitor

Study terminated early and did not move beyond safety run in.

Participants administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants took standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited. Six participants will be enrolled in the safety run in stage. If 1 or fewer of six participants have a DLT, expansion stage will open to enrollment.

Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study terminated early and did not go beyond Safety run in

Rate of Modified Preoperative Endocrine Prognostic Index (mPEPI) Score of 0

Clinical Complete Response (CR)

Clinical Partial Response (PR)

Participants will be administered 1500 mg Durvalumab intravenously every 4 weeks for 6 cycles. Participants will also take standard of care 1 mg anastrozole daily by mouth for 6 months. Letrozole 2.5 mg or exemastane 25 mg may be substituted for anastrozole if an intolerance to anastrozole is exhibited.

Durvalumab: 1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.

Anastrozole 1mg: Participants will self administer 1 mg anastrozole by mouth daily for 6 months.

Letrozole 2.5mg: Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.

Exemestane 25 MG: Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.

Expansion: Durvalumab + Aromatase Inhibitor

Overall Study

Bone Density Conservation Agents

Reproductive Control Agents

Tamoxifen

Mitogens

Goserelin

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Triptorelin Pamoate

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3

postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3

Tamoxifen 20mg

Gonadotropin Releasing Hormone (GnRH) agonist

Triptorelin

Artamonova Elena

Elena Kovalenko

Tatiana Titova

Kovalenko Elena

Titova Tatiana

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Nonrandomized, retrospective clincal trial

Eligible postmenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily before surgery

or

Eligible premenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily in combination with ovarian suppression before surgery

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia.

Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.

the preoperative endocrine prognostic index (PEPI)- consisting of the pathological tumor size, pathological node status, Ki67 labeling index, and ER status of residual tumors after NAE

DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.

Blokhin's Russian Cancer Research Center

Carcinoma

Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen.

Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.

Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.

Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.

Exemestane 25 mg

Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.

Yvonne E Taul, RN

Erin E Burke, MD

Veronica M Jones, MD

The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Largest caliper measurement (millimeters) on post-therapy imaging vs. largest final size of tumor

Evaluate the effect of neoadjuvant endocrine therapy (6-months course) on margin status of breast conservation surgery for women with early stage, low-risk breast cancer, defined as ER-positive, HER2-negative, node-negative breast carcinoma (single lesion only). Negative margin status is defined as no tumor on ink.

The following parameters are required from pathologic examination in order to calculate Residual Cancer Burden (RCB) after neoadjuvant treatment: Primary tumor bed area, overall cancer cellularity (as percentage of area), percentage of cancer that is in situ disease, number of positive lymph nodes and diameter of largest metastasis. These parameters are filled in in the calculator that is available online to calculate the Residual Cancer Burden index: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3

Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response)

The Breast-Q© is a patient reported outcome measure for breast surgery that measures patient reported satisfaction and quality of life (QOL) developed by Memorial Sloan Kettering Cancer Center. It is comprised of 10 scales that address: 1) psychosocial well-being, 2) sexual well-being, 3) satisfaction with breasts, 4) physical well-being, 5) adverse effects of radiation, 6) satisfaction with information - breast surgeon, 7) satisfaction with information - radiation oncologist, 8) satisfaction with surgeon, 9) satisfaction with medical team, 10) satisfaction with office staff. Each module is scored from 0-100 where higher scores reflect a better outcome.

Veronica Morgan Jones

Assistant Professor

elacestrant 400 mg/day orally once daily on a continuous dosing schedule

standard endocrine treatment - the same they were receiving at the time of ctDNA detection

400mg QD orally on a continuous dosing schedule

Elacestrant

20 mg QD orally on a continuous dosing schedule

2.5 mg QD orally on a continuous dosing schedule

1 mg QD orally on a continuous dosing schedule

25 mg QD orally on a continuous dosing schedule

EORTC HQ

Daniela Wayllace

Sylvie Bartholomeus

Michail Ignatiadis

Elise Vrebosch

Marthe Bosque

Wim Demey

Boudewijn Dullens

Nathalie Blondeel

Elodie Villar

Cedric Van Marcke De Lummen

Stephanie Adam

Pauline Isenborghs

Sarah Lefevre

Thecle Fourneaux

Alexandra Sperone

Benedicte Petit

Caterina Confente

Ellen Callens

Charlotte Vankeirsbilk

Marianne Hanssens

Sofie Demasure

Joke Deroover

Beatrijs Steelandt

Patrick Neven

Rina Talpe

Laura Tanghe

Barbara Busssels

Karin Schotte

Barbara Stragier

Jan Demol

Tine Vanlancker

Caroline Yague

Monique Gilsoul

Donnatienne Taylor

Stephanie Henri

Nel Bovin

Sarah Geentjens

Inne Renders

Valerie Graindorge

Charlotte Trussart

Annelore Barbeaux

Thomas Grellety

Jean-Briac Prevost

Abeer Najem

julien Perron

Tévy San

Dominique Spaeth

Thierry Petit

Eleonora De Maio

Lothar Mueller

Wolfgang Janni

Vesna Bjelic-Radisic

Lisa Prior

Geraldine Coyne O'Sullivan

Catherine Kelly

Ciara O'Connor

Fabio Puglisi

Paola Poletti

Icro Meattini

Filippo Giovanardi

Federica Villa

Anna Mercanti

Ugo De Giorgi

Fabio Conforti

Giuseppe Curigliano

Federico Sottotetti

Anna Maria Mosconi

Emmanouil Saloustros

This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse.

During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood.

Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse

DMFS defined as the time from randomisation until first distant metastatic recurrence or death from any cause, whichever occurs first

defined as the proportion of randomised patients who had a negative ctDNA test result at month 1

Breast International Group

Menarini Group

European Organisation for Research and Treatment of Cancer - EORTC

Symptoms and General Pathology

Neoplasm Metastasis

Capecitabine

Paclitaxel

Fulvestrant

Albumin-Bound Paclitaxel

Prolactin Release-Inhibiting Factors

Tubulin Modulators

Antimitotic Agents

Antimetabolites

\* Paclitaxel: administrated at the dose of 80 mg/m² as a 1-hour intravenous infusion every week (i.e., D1, D8 and D15) of a 3-week cycle.

OR

\* Capecitabine: given orally at a dose of 2000 to 2500 mg/m² daily for 14 days followed by a 7-day rest period every 3 weeks.

\* Letrozole: continuous orally administration of 2.5 mg/day (1 tablet/day) OR anastrozole continuous orally administration of 1 mg/day (1 tablet/day) in combination with oral abemaciclib 150 mg (BID: twice a day) continuous for patients NSAI naïve or relapsing \>1 year after the end of adjuvant ET.

OR

\* Fulvestrant: 500 mg intramuscular on D1-D15-D29 (loading dose). Then 500 mg every 28 days (maintenance dose) with oral abemaciclib 150 mg BID continuous for patients relapsing on adjuvant or less than one year after completion of adjuvant NSAI.

For women with a non-menopausal status at inclusion, a concomitant Luteinizing hormone-releasing hormone (LH-RH) agonist will be administered in combination with ET every 28 days. The LH-RH agonist drug to be used will be left to the investigator's choice.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer	NCT03874325	Breast Cancer Hormone Recepto...	Durvalumab Anastrozole 1mg Letrozole 2.5mg Exemestane 25 M...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia	NCT05800197	Breast Cancer Neoadjuvant End...	Tamoxifen 20mg Anastrozole 1mg Letrozole 2.5mg Goserelin Triptorelin	18 Years -	Blokhin's Russian Cancer Research Center
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer	NCT05150652	Breast Cancer HER2-negative B... Node-negative B... Breast Carcinom...	Anastrozole 1mg Letrozole 2.5mg Exemestane 25 m... Tamoxifen	18 Years - 99 Years	University of Kentucky
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)	NCT05512364	ER-positive Bre... HER2-negative B... Stage IIB Breas... Stage III Breas...	Elacestrant Tamoxifen Letrozole 2.5mg Anastrozole 1mg Exemestane 25 M...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)	NCT05512364	ER-positive Bre... HER2-negative B... Stage IIB Breas... Stage III Breas...	Elacestrant Tamoxifen Letrozole 2.5mg Anastrozole 1mg Exemestane 25 M...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer	NCT04158362	Cancer Metastat...	Paclitaxel inje... Capecitabine ta... Letrozole 2.5mg Anastrozole 1mg Fulvestrant Pre... Abemaciclib	18 Years -	UNICANCER
Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer	NCT03874325	Breast Cancer Hormone Recepto...	Durvalumab Anastrozole 1mg Letrozole 2.5mg Exemestane 25 M...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for anastrozole 1mg