Clinical trials: Early Stage Estrogen Receptor (ER) Positive Breast Cancer
Breast Cancer, Estrogen Receptor Positive Tumor
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in…
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- TOUCH (NCT03644186)
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 54 sites in Belgium, France and 2 more
- Volunteers
- 147 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer, Breast Cancer Female
Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer
This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR).
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Adenocarcinoma
- Trial name
- NCT03137693
- Testing
- Standard of Care Schedule Variation: SABR, Breast-conserving Surgery
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
Dose Optimization of Rosuvastatin in Early Stage and Metastatic Estrogen Receptor Positive Breast Cancer Patients on Endocrine Therapy
Patients will be treated in a dose escalation scheme to investigate a role for the addition of a statin in the treatment of estrogen receptor positive breast cancer. Patients will take oral rosuvastatin daily.
- Trial name
- NCT02483871
- Testing
- Rosuvastatin
- Where
- United States
- Sponsor
- Duke University
Early-stage Breast Cancer, Estrogen-receptor-positive Breast Cancer
Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)
Out of all proportion to its short duration, the perioperative period is critical in determining the long-term outcome of cancer.
- Trial name
- KePreSt (NCT06150898)
- Testing
- Prospective data and sample collection, Ketorolac 10 Mg Oral Tablet, Pregabalin 75mg
- Where
- Belgium
- Volunteers
- 112 people
- Sponsor
- Jules Bordet Institute
Breast Cancer
Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio.
- Trial name
- ImmunoADAPT (NCT03573648)
- Testing
- Avelumab, Endocrine therapy, Palbociclib
- Where
- 4 sites in United States
- Volunteers
- 33 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer, Estrogen Receptor Positive Tumor
Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
This is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- NCT04997798
- Testing
- Trastuzumab Pyrotinib Exemestane Dalpiciclib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Breast Cancer
Studying Tumor Tissue Samples From Patients With Early-Stage Breast Cancer
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
- Trial name
- NCT00899639
- Sponsor
- Rutgers, The State University of New Jersey
Estrogen Receptor Positive, HER2/Neu Negative
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor…
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer
- Trial name
- NCT01928186
- Testing
- Fluorothymidine F-18, Positron Emission Tomography, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Washington
Early-Stage Breast Carcinoma, Estrogen Receptor Positive Tumor
Neoadjuvant Response-guided Treatment of Luminal B-type Tumors and Luminal A-type Tumors With Node Metastases
The purpose of this neoadjuvant trial is to evaluate efficacy and toxicity of chemotherapy using weekly paclitaxel (arm A) versus the combination of the cdk 4/6 inhibitor palbociclib and standard endocrine treatment (arm B).
- Trial name
- PREDIX LumB (NCT02603679)
- Testing
- Paclitaxel, Tamoxifen + Palbociclib, Aromatase Inhibitor + Palbociclib
- Where
- 3 sites in Sweden
- Volunteers
- 181 people
- Sponsor
- Thomas Hatschek
Breast Cancer, Cardiac Toxicity
Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Nonmetastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them…
- Conditions
- Breast Cancer, Cardiac Toxicity, Perioperative/Postoperative Complications
- Trial name
- NCT01093235
- Testing
- bevacizumab, cyclophosphamide, docetaxel
- Where
- United Kingdom
- Volunteers
- 800 people
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Breast Cancer
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients
This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors.
- Trial name
- NCT02625935
- Where
- 4 sites in United States
- Volunteers
- 206 people
- Sponsor
- NanoString Technologies, Inc.
Breast Cancer
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
The purpose of this trial is to estimate the recommended dose (RD) of [177Lu]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor…
- Trial name
- NCT05870579
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Ribociclib
- Where
- 13 sites in United States, China and 5 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Estrogen Receptor-positive Breast Cancer
Evaluation of Endocrine Therapy Effects of Host Immunity in Early Stage Breast Cancer
The purpose of this research study is to learn about the effects that standard of care endocrine therapies have on the immune system's response to cancer by looking at the number and types of immune cells present and how they…
- Conditions
- Breast Cancer, Estrogen Receptor-positive Breast Cancer, Healthy
- Trial name
- NCT03719495
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Duke University
Breast Cancer, Early Stage Estrogen Receptor (ER) Positive Breast Cancer
Assessment of the Decision-making Impact of the Breast Cancer Index in Recommending Extended Adjuvant Endocrine Therapy for Patients With Early Stage ER-positive Breast Cancer
Investigators will examine the impact of the Breast Cancer Index (BCI) result on patients' anxiety / fear of recurrence and satisfaction with decisions regarding endocrine therapy.
- Trial name
- NCT02057029
- Testing
- BCI Assay Results
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- Yale University
Breast Cancer
Fulvestrant (FASLODEX™) as a Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
The purpose of this study is to evaluate fulvestrant in the preliminary stage of breast cancer treatment and assess the relationship between dose, exposure, degree of reduction in tumor markers, and efficacy in postmenopausal…
- Trial name
- NCT00093002
- Testing
- Fulvestrant
- Where
- 31 sites in United States, Austria and 4 more
- Volunteers
- 179 people
- Sponsor
- AstraZeneca
Breast Cancer
NEODOXy: Targeting Breast Cancer Stem Cells With Doxycycline
Despite modern surgical and medical treatments, breast cancer can re-occur and lead 20% of patients to death. During the last 20 years, pre-clinical studies have shown that treatment failures may be due to the presence of a…
- Trial name
- NCT06452394
- Testing
- Doxycyclin
- Where
- 8 sites in Switzerland
- Volunteers
- 50 people
- Sponsor
- Swiss Cancer Institute
Breast Cancer
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer…
- Trial name
- NCT01101438
- Testing
- metformin hydrochloride
- Where
- 344 sites in United States, Canada and 2 more
- Volunteers
- 3,649 people
- Sponsor
- Canadian Cancer Trials Group
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
Breast Cancer
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of…
- Trial name
- NCT03725059
- Testing
- Pembrolizumab (K), Paclitaxel (X), Doxorubicin (A)
- Where
- 244 sites in United States, Australia and 22 more
- Volunteers
- 1,240 people
- Sponsor
- Merck Sharp & Dohme LLC
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer
This clinical trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) based minimal residual disease (MRD) detection works for patients with early-stage breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- NCT07136493
- Testing
- Biospecimen Collection, Electronic Health Record Review, Survey Administration
- Where
- 5 sites in United States
- Sponsor
- City of Hope Medical Center