Clinical trials: ER-positive Her2-negative Early Breast Cancer
ER-positive Her2-negative Early Breast Cancer
Assessment of Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in ER-positive, Her2-negative Early Breast Cancer
The need/benefit of adjuvant chemotherapy could be negligible for a certain category of patient with newly diagnosed unilateral non metastatic breast cancer.
- Trial name
- OPTIGEN (NCT03080428)
- Testing
- Genomic test
- Sponsor
- UNICANCER
Breast Cancer, Breast Cancer, Early-Onset
Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%
This study is a window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) or tamoxifen in estrogen receptor-positive (ER[+])/human epidermal growth factor receptor 2-negative (HER2[-]) primary…
- Trial name
- EMPRESS (NCT05659563)
- Testing
- Giredestrant, Tamoxifen
- Where
- 18 sites in France, Spain
- Volunteers
- 92 people
- Sponsor
- MedSIR
Breast Cancer, ER-positive Breast Cancer
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer
The majority of patients (pts) with breast cancer have hormone receptor positive (HR+) disease, and this holds true for pts with advanced breast cancer (ABC).
- Conditions
- Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05826964
- Testing
- AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Miami
Breast Cancer
Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy
Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy.
- Trial name
- NCT05069038
- Testing
- Palbociclib 125mg
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Nebraska
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
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Trastuzumab or Lapatinib Ditosylate in Treating Women With Early Breast Cancer
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- EPHOS-B (NCT01104571)
- Testing
- trastuzumab, lapatinib ditosylate, laboratory biomarker analysis
- Where
- United Kingdom
- Volunteers
- 257 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Breast Cancer
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-)…
- Trial name
- Neo-AGILE (NCT06259929)
- Testing
- Abemaciclib 150 MG + Giredestrant 30 MG
- Where
- 8 sites in Italy
- Volunteers
- 51 people
- Sponsor
- Fondazione Oncotech
Breast Cancer, Breast Neoplasm
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when…
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Cancer Female, Breast Cancer Invasive
- Trial name
- RESPONSE (NCT05020860)
- Testing
- Paclitaxel, Carboplatin, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 185 people
- Sponsor
- Baylor Breast Care Center
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
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8
Testing Low Dose Tamoxifen for Invasive Breast Cancer, LoTam Trial
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- LoTam (NCT06671912)
- Testing
- Anastrozole, Letrozole, Exemestane
- Where
- 732 sites in United States, Puerto Rico
- Volunteers
- 1,556 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Early Breast Cancer (Phase 2), Advanced Breast Cancer (Phase 1b)
Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer
PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and…
- Trial name
- NCT01430585
- Testing
- PF-04691502, PF-04691502 in combination with Letrozole, Letrozole
- Where
- 5 sites in Belgium, Italy and 2 more
- Volunteers
- 14 people
- Sponsor
- Pfizer
Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or…
- Trial name
- NCT07890597
- Testing
- Atirmociclib, giredestrant
- Volunteers
- 3,800 people
- Sponsor
- Pfizer
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, Estrogen Receptor Positive Tumor
OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk
Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-negative Breast Cancer, Premenopausal Breast Cancer
- Trial name
- INTERSTELLAR (NCT05333328)
- Testing
- Ovarian function suppression with endocrine treatments
- Where
- 2 sites in South Korea
- Volunteers
- 418 people
- Sponsor
- Gangnam Severance Hospital
Early Breast Cancer
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk…
- Trial name
- NCT04961996
- Testing
- Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist
- Where
- 621 sites in United States, Argentina and 52 more
- Volunteers
- 4,170 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment.
- Trial name
- NCT06126003
- Testing
- Observation
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BioCorteX Inc
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
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
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