Clinical trials: High Risk for Breast Cancer, active
Breast Cancer Stage I, Triple Negative Breast Cancer (TNBC)
OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes
The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment.
- Trial name
- OPTImaL (NCT06476119)
- Testing
- Adjuvant chemotherapy, No adjuvant chemotherapy
- Where
- 28 sites in Netherlands
- Volunteers
- 490 people
- Sponsor
- The Netherlands Cancer Institute
Breast Cancer, Ductal Carcinoma
Randomized Double-Blind Phase II Trial of Baby Exemestane Versus Baby Tamoxifen in Post-Menopausal Women at High Risk for Breast Cancer
The goal of this research study is to evaluate the efficacy and safety of low-dose exemestane versus low-dose tamoxifen in post-menopausal women at high risk for breast cancer.
- Conditions
- Breast Cancer, Ductal Carcinoma, Estrogen-receptor-positive Breast Cancer, Atypical Lobular Hyperplasia
- Trial name
- BabyTEARS (NCT07499999)
- Testing
- Exemestane, Tamoxifen
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Dana-Farber Cancer Institute
High Risk for Invasive Breast Cancer
SHORTened Duration of TAMoxifen
The purpose of this study is to learn whether a shorter-duration, low-dose tamoxifen regimen can reduce the risk of developing breast cancer or breast cancer recurrence in post-menopausal women who are at increased risk for…
- Trial name
- NCT07806630
- Testing
- Tamoxifen, Tamoxifen (Nolvadex)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Rutgers, The State University of New Jersey
Breast Atypical Hyperplasia, Breast Carcinoma
Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer
This phase IIA trial compares the effect of acolbifene versus low dose tamoxifen in preventing breast cancer in premenopausal women at high risk for developing breast cancer.
- Conditions
- Breast Atypical Hyperplasia, Breast Carcinoma, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ
- Trial name
- NCT05941520
- Testing
- Acolbifene Hydrochloride, Biospecimen Collection, Mammography
- Where
- 4 sites in United States
- Volunteers
- 80 people
- Sponsor
- National Cancer Institute (NCI)
Early-Stage Breast Cancer, Neoadjuvant Therapy
COGNITION: Genomics-Guided Precision Oncology in Early High-Risk Breast Cancer
The COGNITION diagnostic platform elucidates the biomarker profile of neoadjuvant chemotherapy-resistant residual bulk tumors in high risk early breast cancer patients.
- Trial name
- COGNITION (NCT05906407)
- Testing
- Genomic Profiling / Sequencing
- Where
- 12 sites in Germany
- Volunteers
- 2,000 people
- Sponsor
- German Cancer Research Center
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
Breast Cancer Metastatic, Breast Cancer Stage IV
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the…
- Trial name
- SAFIR3LibHERty (NCT06680596)
- Testing
- trastuzumab derxutecan
- Where
- 40 sites in France
- Volunteers
- 80 people
- Sponsor
- UNICANCER
Ultrasonography, Breast Neoplasm Female
Intelligent Remote Intervention for High-risk Breast Cancer Populations
The goal of this clinical trial is to compare the effects of modern remote health intervention regime with traditional in-person intervention strategies for high-risk breast cancer groups that with BI-RADS 3 or higher nodules.
- Conditions
- Ultrasonography, Breast Neoplasm Female, Breast Carcinoma, Health Education
- Trial name
- NCT06193707
- Testing
- the Remote Intervention, the Traditional Intervention
- Volunteers
- 1,250 people
- Sponsor
- Qianfoshan Hospital
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the…
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- NCT07391774
- Testing
- Anastrozole, Biospecimen Collection, Bone Scan
- Where
- 258 sites in United States, Puerto Rico
- Volunteers
- 1,978 people
- Sponsor
- National Cancer Institute (NCI)
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma
High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer
This phase II trial tests how well radiation therapy with pembrolizumab and chemotherapy (paclitaxel or nab-paclitaxel or carboplatin and gemcitabine) works in treating patients with PD-L1 positive triple negative breast cancer…
- Trial name
- NCT06492759
- Testing
- Radiation Therapy, Pembrolizumab, Nab-paclitaxel
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Emory University
Colorectal Cancer, Breast Cancer
Impact of Aerobic Exercise on the Anticancer Immune Response in Patients Receiving Cancer Treatment
The goal of this clinical trial is to determine to what extent anticancer immune cells mobilized by aerobic exercise exhibit migratory and functional capacity towards cancer cells in patients undergoing treatment for breast or…
- Conditions
- Colorectal Cancer, Breast Cancer, Non Metastatic Cancer
- Trial name
- Immuno-Ex (NCT06911970)
- Testing
- Exercise
- Where
- 2 sites in Canada
- Volunteers
- 44 people
- Sponsor
- Université de Sherbrooke
Breast Cancer Female, Cardiometabolic Syndrome
Metabolic Flexibility and Autonomic Control After Muscle Power vs Metabolic Power Training in Postmenopausal Oncological Women: the POWER Health Study
POWER Health is a randomized clinical trial with a two-arm parallel design whose objectives are 1) to study metabolic flexibility and autonomic function (both capacities that describe cardiovascular health) in a sample of…
- Conditions
- Breast Cancer Female, Cardiometabolic Syndrome, Metabolism Disorder, Lipid, Autonomic Dysfunction
- Trial name
- POWER Health (NCT06336070)
- Testing
- HIIT program (8 weeks), MPI program (8 weeks)
- Where
- Spain
- Volunteers
- 56 people
- Sponsor
- University of Valencia
Breast Cancer
S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die.
- Trial name
- NCT00070564
- Testing
- pegfilgrastim, AC regimen, cyclophosphamide
- Where
- 542 sites in United States, Canada and 1 more
- Volunteers
- 3,294 people
- Sponsor
- SWOG Cancer Research Network
Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer, Hot Flashes
A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer…
- Trial name
- OASIS-4 (NCT05587296)
- Testing
- Elinzanetant (BAY3427080)
- Where
- 102 sites in Austria, Belgium and 14 more
- Volunteers
- 474 people
- Sponsor
- Bayer
Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.
- Trial name
- NCT04842617
- Testing
- SHR6390
- Where
- China
- Volunteers
- 5,274 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
Genetic Risk Estimations for Influencing Decision Making in Women at High Risk of Breast Cancer, GENRE 2 Study
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score will aid women at risk of breast…
- Trial name
- GENRE2 (NCT04474834)
- Testing
- Polygenic Risk Score
- Where
- 5 sites in United States
- Volunteers
- 737 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Radiotherapy, Immunotherapy
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
The 1100 study is an open-label, Phase I, dose escalation and expansion prospective clinical study to assess the safety of intratumoral injection of NBTXR3 activated by radiotherapy in combination with anti-PD-1 therapy.
- Conditions
- Radiotherapy, Immunotherapy, Microsatellite Instability-High Solid Malignant Tumour, Metastasis From Malignant Tumor of Liver
- Trial name
- NCT03589339
- Testing
- NBTXR3, SABR, Nivolumab
- Where
- 13 sites in United States
- Volunteers
- 145 people
- Sponsor
- Nanobiotix
Breast Cancer
NeoadjuVAnt muLti-agENT Chemotherapy or Patritumab Deruxtecan With or Without endocrINE Therapy for High-risk HR+/HER2- Breast Cancer - VALENTINE Trial
VALENTINE is a parallel, non-comparative, three-arm, randomized 1:2:2 open-label, multicenter, exploratory study in women or men with primary operable HR+/HER2-negative breast cancer with ki67 ≥ 20% and/or high genomic risk…
- Trial name
- VALENTINE (NCT05569811)
- Testing
- Patritumab deruxtecan, Chemotherapy, Letrozole
- Where
- 25 sites in Spain
- Volunteers
- 120 people
- Sponsor
- SOLTI Breast Cancer Research Group
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.
ER+HER2- Breast Cancer
SKB264 Combined With KL-A167 Neoadjuvant Therapy for Early-stage, High-risk ER+/HER2- Breast Cancer
This study aimed to evaluate the efficacy and safety of SKB264 combined with KL-A167 as neoadjuvant therapy in early-stage high-risk ER+HER2- breast cancer patients.
- Trial name
- NeoSaciA (NCT07109284)
- Testing
- Sacituzumab tirumotecan, Tagitanlimab
- Volunteers
- 55 people
- Sponsor
- West China Hospital