Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Aromatase Inhibitors

Blood sample will be collected every 3 months during two years to determine ESR1 mutations

Blood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations

Determination of ESR1 mutations

Anne Perdrix, MD

The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.

Breast cancer is the most common cancer in woman. Aromatase inhibitors have demonstrated a real efficacy however a resistance to treatment exists.

ESR1 mutations appear like involved in the mechanism of resistance to aromatase inhibitors treatment.

The purpose of the study is to determine the frequency ESR1 mutations by Digital PCR in patient with metastatic breast cancer.

The significance of the Digital PCR technique will be determined first in plasma issued from healthy volunteers.

At the initiation of aromatase inhibitors treatment patient with metastatic breast cancer will be included in the study. During their follow-up visit every 3 months), their status towards their disease will be collected and a plasma will be collected too.

When the patient progress clinically or radiologically the plasma concomitant to this progression will be analysed by Digital PCR to detect ESR1 mutations.

The patient will be followed during 2 years.

Study of ESR1 Mutations in Metastatic Breast Cancer

Determination of ESR1 Mutations by Digital PCR During Aromatase Inhibitor Treatment in Metastatic Breast Cancer

Determination of the frequency of ESR1 mutation in patient who have a clinical and/or a radiological progression disease

Determination of frequency of patient with a progression disease and without any ESR1 mutations

Time between introduction of aromatase inhibitor and detection of ESR1 mutations by digital PCR

Centre Henri Becquerel

Bone Density Conservation Agents

Antineoplastic Agents

Tamoxifen

Fulvestrant

Estrogens

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

Hormones

Antineoplastic Agents, Hormonal

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

ESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy

Fulvestrant 500 mg given as two 5 ml intramuscular inections, one in each buttoc, on days 1, 15, 2 and every 2 ( ) days thereafter.

Zhimin Shao

Yizhou Jiang

This is an open-label, single arm, phase II trial to evaluate the efficacy and safety of 500mg Fulvestrant (Faslodex®) in ESR1 mutated postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer after previous aromatase inhibitor therapy. Fifty patients will be enrolled and treated with 500 mg Fulvestrant until disease progression or study closed.

Treatment will continue until disease progression, unless any of the criteria for treatment discontinuation are met first. If a patient progresses during the treatment period, the patient must be withdrawn from the treatment and further treatment will be at the investigator's discretion.

All patients will be followed up for disease progression, regardless of whether they have discontinued treatment, unless they have withdrawn consent.

Efficacy will be determined based on tumor assessments performed by each investigator according to RECIST 1.1. Safety will be monitored based on the frequency and severity of adverse events (AEs), as assessed by Common Terminology Criteria (CTC) grade version 4.0.

Tumor assessments will be assessed by computed tomography (CT) or magnetic resonance imaging (MRI) or X ray if necessary every 12 weeks for all patients until documented evidence of objective disease progression.

Reporting of SAEs to regulatory authorities will be done by the investigator in accordance with CFDA regulations.

The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer

An Open-Label, Single Arm, Phase II Trial to Evaluate the Efficacy of 500mg Fulvestrant (Faslodex) in ESR1 Mutated Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer After Previous Aromatase Inhibitor Treatment

The study will be closed at all the patients progressed or 12 months after the last patient has been recruited depends on which one met first. From date of the first recruitment until the date of all the patients progressed or 12 months after the last patient has been recruited, whichever came first, assessed up to 10 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of ESR1 Mutations in Metastatic Breast Cancer	NCT02473120	Metastatic Brea...	Determination o...	18 Years -	Centre Henri Becquerel
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
The Efficacy of Fulvestrant in ESR1(Estrogen Receptor 1) Mutated Metastatic Breast Cancer	NCT03202862	Breast Neoplasm...	Fulvestrant	-	Fudan University

Spots Global Cancer Trial Database for esr1

Every month we try and update this database with for esr1 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 esr1

Every month we try and update this database with for esr1 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 esr1 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.