Clinical trials: Estrogen Receptor-positive Breast Cancer
Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ
Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy…
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Stage II Breast Cancer, Stage IIA Breast Cancer
- Trial name
- NCT01293032
- Testing
- Neoadjuvant Therapy, Therapeutic Conventional Surgery, Laboratory Biomarker Analysis
- Where
- 8 sites in United States, Canada
- Volunteers
- 59 people
- Sponsor
- Virginia Commonwealth University
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation…
- Trial name
- DESCENT (NCT07153757)
- Testing
- Endocrine Therapy of Physician's Choice
- Where
- China
- Volunteers
- 2,934 people
- Sponsor
- Fudan University
Breast Cancer
Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.
- Trial name
- NCT01463007
- Testing
- Accelerated partial breast irradiation, Extended Follow up
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Jaroslaw Hepel
Breast Cancer
Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
This protocol will study the impact of cryoablation on immune response in patients diagnosed with invasive breast cancers smaller than 1.5 cm. It will profile the immune response to cryoablation of invasive breast cancers.
- Trial name
- NCT01856036
- Testing
- Cryoablation
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Saint John's Cancer Institute
Breast Cancer
CIrCuLAting Dna ESr1 Gene Mutations Analysis
The estrogen-dependent nature of breast cancer was first reported in 1896 with the publication of George Beatson's observations on the regression of breast cancer following oophorectomy.
- Trial name
- CICLADES (NCT03318263)
- Testing
- next-generation sequencing (NGS)
- Where
- 10 sites in France
- Volunteers
- 146 people
- Sponsor
- Institut de Cancérologie de Lorraine
Metastatic Breast Cancer
Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.
Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase…
- Trial name
- Pangeia-2 (NCT06417801)
- Where
- 6 sites in Brazil
- Volunteers
- 170 people
- Sponsor
- AstraZeneca
Ductal Breast Carcinoma In Situ, Estrogen Receptor Positive
Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
This phase II trial studies how well accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not spread beyond the breast or the axillary lymph…
- Conditions
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Positive, Invasive Breast Carcinoma, Progesterone Receptor Positive
- Trial name
- TRIUMPH-T (NCT02526498)
- Testing
- Accelerated Partial Breast Irradiation, High-Dose Rate Brachytherapy, Questionnaire Administration
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Rutgers, The State University of New Jersey
Breast Cancer
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice…
- Trial name
- BOLERO-6 (NCT01783444)
- Testing
- Capecitabine, Exemestane, Everolimus
- Where
- 83 sites in United States, Argentina and 16 more
- Volunteers
- 309 people
- Sponsor
- Novartis Pharmaceuticals
Post Menopausal Breast Cancer
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer…
- Trial name
- EVEREXES (NCT03176238)
- Testing
- everolimus, exemestane
- Where
- 55 sites in Australia, India and 11 more
- Volunteers
- 235 people
- Sponsor
- Novartis Pharmaceuticals
Estrogen Receptor Positive, HER2 Positive Breast Carcinoma
Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive
This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone…
- Conditions
- Estrogen Receptor Positive, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Progesterone Receptor Positive
- Trial name
- NCT00390455
- Testing
- Fulvestrant, Laboratory Biomarker Analysis, Lapatinib Ditosylate
- Where
- 368 sites in United States
- Volunteers
- 295 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole
There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI…
- Trial name
- BOLERO-2 (NCT00863655)
- Testing
- Everolimus, Exemestane
- Where
- 200 sites in United States, Australia and 22 more
- Volunteers
- 724 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
- Trial name
- DARE (NCT04567420)
- Testing
- Palbociclib, Fulvestrant, Adjuvant Therapy
- Where
- 19 sites in United States
- Volunteers
- 70 people
- Sponsor
- Criterium, Inc.
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics
Breast Cancer
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate…
- Trial name
- NCT03471663
- Testing
- D-0502, palbociclib
- Where
- 15 sites in United States, China
- Volunteers
- 200 people
- Sponsor
- InventisBio Co., Ltd
Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma
A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)
The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety…
- Trial name
- NCT02900664
- Testing
- PDR001, ACZ885, CJM112
- Where
- 23 sites in United States, Belgium and 7 more
- Volunteers
- 283 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
STRIDE - STimulating Immune Response In aDvanced brEast Cancer
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).
- Trial name
- STRIDE (NCT00925548)
- Testing
- Tecemotide (L-BLP25) and Hormonal Treatment, cyclophosphamide, sodium chloride (NaCl)
- Where
- 29 sites in United States, Australia and 10 more
- Volunteers
- 16 people
- Sponsor
- EMD Serono
Breast Cancer
Sorafenib and Letrozole, Anastrozole, or Exemestane in Treating Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Metastatic Breast Cancer
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells.
- Trial name
- NCT00573755
- Testing
- anastrozole, exemestane, letrozole
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Mayo Clinic
Breast Neoplasms, Neoplasms, Hormone-Dependent
The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer
The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another…
- Trial name
- NCT00097344
- Testing
- Atamestane, Toremifene, Letrozole
- Where
- 104 sites in United States, Bulgaria and 3 more
- Volunteers
- 842 people
- Sponsor
- Intarcia Therapeutics
Advanced or Metastatic Breast Cancer
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with…
- Trial name
- NCT05187832
- Testing
- AND019 PO QD
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Kind Pharmaceuticals LLC
Breast Cancer
Letrozole Plus Oral Cyclophosphamide Plus/Minus Sorafenib as Primary Systemic Treatment in Breast Cancer Patients
Endocrine therapy is the mainstay of systemic treatment in patients with endocrine responsive breast cancer. Aromatase inhibitors are the most active agents in post-menopausal women.
- Trial name
- NCT00954135
- Testing
- letrozolo+cyclophosphamide, letrozolo+sorafenib+cyclophosphamide
- Where
- 2 sites in Italy
- Volunteers
- 190 people
- Sponsor
- University of Turin, Italy