Clinical trials: Estrogen Receptor-positive Breast Cancer
Estrogen Receptor Positive Breast Cancer
Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer
This is a two stage study, with an initial dose escalation phase I study and subsequent double blind randomised phase II controlled trial.
- Trial name
- FAKTION (NCT01992952)
- Testing
- AZD5363, Fulvestrant
- Where
- 21 sites in United Kingdom
- Volunteers
- 149 people
- Sponsor
- Velindre NHS Trust
Breast Cancer
Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women
This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive…
- Trial name
- PEARL (NCT02028364)
- Testing
- Everolimus, Exemestane
- Where
- 5 sites in Belgium
- Volunteers
- 55 people
- Sponsor
- Jules Bordet Institute
Primary Non-metastatic Breast Cancer, Who Remain Disease-free
Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy
A significant number of patients relapse and eventually die, particularly if they were initially diagnosed with large nodes involvement and/or T3/4 diseases.
- Trial name
- NCT01805271
- Testing
- Everolimus
- Where
- 2 sites in France
- Volunteers
- 1,278 people
- Sponsor
- UNICANCER
Breast Cancer Female
Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer
A short pre-surgical non-therapeutic trial involving postmenopausal women with newly diagnosed eR+, HeR2-negative operable breast cancers.
- Trial name
- NCT03747042
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of Texas Southwestern Medical Center
Metastatic Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer
This phase II trial studies how well pembrolizumab works when given together with endocrine therapy and palbociclib in treating postmenopausal patients with newly diagnosed stage IV estrogen receptor positive breast cancer that…
- Trial name
- NCT02778685
- Testing
- Fulvestrant, Laboratory Biomarker Analysis, Letrozole
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- City of Hope Medical Center
ER+ Breast Cancer, HER2-negative Breast Cancer
A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer
Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy.
- Trial name
- TRAK-ER (NCT04985266)
- Testing
- Palbociclib 125Mg Tab, Fulvestrant injection, Tamoxifen
- Where
- 49 sites in France, United Kingdom
- Volunteers
- 1,100 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Triple Negative Breast Cancer, Hormone Receptor Positive (HR+), HER2-negative Breast Cancer
Pre-op Pembro + Radiation Therapy in Breast Cancer (P-RAD)
This research trial is studying a combination of neoadjuvant radiotherapy (RT), immunotherapy (pembrolizumab) and chemotherapy for lymph node-positive, triple negative (TN) or hormone receptor positive/HER2-negative breast…
- Conditions
- Triple Negative Breast Cancer, Hormone Receptor Positive (HR+), HER2-negative Breast Cancer, Biopsy-proven, Positive Lymph Node(s)
- Trial name
- NCT04443348
- Testing
- Radiation Therapy Boost, Pembrolizumab, Paclitaxel
- Where
- 10 sites in United States
- Volunteers
- 120 people
- Sponsor
- Laura M. Spring, MD
Breast Cancer Stage II
Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer
This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in…
- Trial name
- RIBOLARIS (NCT05296746)
- Testing
- Ribociclib (neoadjuvant), Chemotherapy (adjuvant), Ribociclib (adjuvant)
- Where
- 51 sites in France, Portugal and 1 more
- Volunteers
- 1,100 people
- Sponsor
- SOLTI Breast Cancer Research Group
Solid Tumors, Ovarian Cancer
Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole
An Open-label Phase 1b Study of ARQ 092 in Combination with other Antineoplastic Agents in Subjects with Selected Solid Tumors
- Conditions
- Solid Tumors, Ovarian Cancer, Endometrial Cancer
- Trial name
- NCT02476955
- Testing
- ARQ 092 + carboplatin + paclitaxel (Closed), ARQ 092 + paclitaxel (Closed), ARQ 092 + anastrozole
- Where
- 5 sites in United States
- Volunteers
- 41 people
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
Breast Cancer
Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCT
To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental and oral surgeons (dental oral management…
- Trial name
- NCT02376985
- Testing
- Oral management, Everolimus
- Where
- Japan
- Volunteers
- 174 people
- Sponsor
- Comprehensive Support Project for Oncology Research
Advanced Metastatic Breast Cancer
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic)…
- Trial name
- NCT03096847
- Testing
- ribociclib, letrozole, goserelin
- Where
- 84 sites in Germany
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Abiraterone Acetate in Treating Postmenopausal Women With Advanced or Metastatic Breast Cancer
RATIONALE: Abiraterone acetate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of abiraterone acetate and to see…
- Trial name
- NCT00755885
- Testing
- abiraterone acetate, laboratory biomarker analysis, pharmacogenomic studies
- Where
- 6 sites in United Kingdom
- Volunteers
- 77 people
- Sponsor
- Cancer Research UK
Hormone Receptor-positive Breast Cancer
Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment in Breast Cancer Patient
Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence.
- Trial name
- NCT05651087
- Testing
- LACUDY
- Volunteers
- 60 people
- Sponsor
- Gun Oh Chong
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
Metastatic Invasive Lobular Carcinoma (mILC)
Longitudinal Tumor Burden Quantification Using Circulating Tumor DNA in Metastatic Lobular Breast Cancer
The goal of this study is to characterize early dynamic changes in ctDNA, which can aid in tailoring early therapy in patients with metastatic Invasive lobular carcinoma (ILC).
- Trial name
- LBC-Monitor (NCT06666439)
- Testing
- circulating tumor DNA (ctDNA)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Julia Foldi
Breast Cancer
Estrogen Receptor-Positive Breast Cancer Patient-Derived Xenografts
The investigators will establish a platform at Dartmouth-Hitchcock Medical Center to generate novel models of estrogen receptor alpha-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, which…
- Trial name
- NCT02752893
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer
Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer
The trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the…
- Trial name
- ADENDOM (NCT02773004)
- Testing
- EPClin genomic test
- Volunteers
- 203 people
- Sponsor
- UNICANCER
Healthy Volunteers
A Study to Assess the Rel Bioavailability, Food Effect and Absolute Bioavailability on the Pharmacokinetics of AZD9833
AstraZeneca AB is developing the test medicine, AZD9833, for the potential treatment of oestrogen receptor (ER) positive breast cancer.
- Trial name
- NCT04546347
- Testing
- [14C]AZD9833 Solution for Infusion, (NMT 22.8 kBq/5mL), AZD9833 film-coated tablet A Dose 1, AZD9833 Oral Solution
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer, Other Disorders of Bone Density and Structure
Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer
The purpose of this study is to identify the combined impact on bone loss as well as the incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast cancer treated with an aromatase inhibitor (AI)…
- Trial name
- POCHARBI (NCT01298362)
- Testing
- Aromatase Inhibitors, Chemotherapy
- Where
- Greece
- Volunteers
- 290 people
- Sponsor
- Hellenic Breast Surgeons Society