Clinical trials: HER2- Negative Breast Cancer
Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
Nipple Aspirate Fluid in Detecting Breast Cancer
This trial studies nipple aspirate fluid in detecting breast cancer. Nipple aspirate fluid may better detect breast cancer earlier than current methods used for screening such as mammograms and breast examinations.
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Trial name
- NCT03715959
- Testing
- Aspiration of Breast, Biospecimen Collection
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Ohio State University Comprehensive Cancer Center
HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC)…
- Conditions
- HER2-negative Breast Cancer, HER2 Negative Breast Carcinoma, Metastatic Breast Cancer, HR+ HER2 Breast Cancer
- Trial name
- ENCORE (NCT06774027)
- Testing
- Specimen collection, Non-Investigational Antibody-Drug Conjugates (ADC), Medical Record Review
- Where
- 3 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
ER-positive, HER2-negative Breast Cancer
A Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]AZD9833
The Sponsor is developing the test medicine, AZD9833 for the potential treatment of estrogen receptor (ER)-positive breast cancer.
- Trial name
- NCT05364255
- Testing
- [14C]AZD9833 Oral Solution, 75 mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer, Metastasis
Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
- Trial name
- NCT05095207
- Testing
- Abemaciclib, Bicalutamide
- Where
- 3 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Icahn School of Medicine at Mount Sinai
Breast Cancer
Preoperative Immunotherapy Combined With Stereotactic Radiation Therapy Boost in the Treatment of HER2-negative Breast Cancer
The goal of the study is to assess the safety and effectiveness of the combination of anti-PD1 immunotherapy (pembrolizumab) and radiotherapy in the preoperative treatment of HER2-negative breast cancer resistant to classical…
- Trial name
- BREAST-BOOSTER (NCT06472583)
- Testing
- Keytruda, Preoperative radiation therapy
- Where
- Poland
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
Breast Cancer, HER2-negative Breast Cancer
Clinical Study of Breast Conserving Surgery Combined With Intraoperative Radiotherapy for Early Breast Cancer
A Single-center, open, prospective study，for analyzing the local recurrence rate, the incidence of incision complications and the aesthetic effect of intraoperative radiotherapy in early breast cancer patients after…
- Trial name
- NCT06375798
- Testing
- radiotherapy
- Where
- China
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- Hebei Medical University Fourth Hospital
Neoplasm, Breast, Congenital, Familial and Genetic Disorders
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or…
- Trial name
- SEQUEL-Breast (NCT05392608)
- Testing
- Alpelisib 150 MG Oral Tablet [Piqray], Fulvestrant
- Where
- 25 sites in Netherlands
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Borstkanker Onderzoek Groep
Healthy Subjects
A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole
This study will be conducted in healthy post-menopausal female subjects to assess the pharmacokinetics (PK) of Camizestrant (AZD9833) when administered alone and in combination with Itraconazole.
- Trial name
- NCT05551897
- Testing
- Camizestrant, Itraconazole
- Where
- United Kingdom
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Breast Cancer Female
Impact of Recurrence Score on Adjuvant Treatment Decisions in Breast Cancer Patients
IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine.
- Trial name
- NCT03961880
- Where
- Germany
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- University Hospital Tuebingen
Advanced HER2 Negative Breast Carcinoma, HRD+Breast Cancer
Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive HER2 Negative Advanced Breast Cancer
This study is planned to include 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of…
- Trial name
- NCT05085626
- Testing
- fluzoparib+chidamide, fluzoparib+camrelizumab
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
HER2-positive Breast Cancer, HER2 Low
ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer
This is an open-label, single-arm, multi-site phase I/Ib trial with SYD985, an antibody-drug conjugate (ADC) targeting HER2 on the cell membrane, combined with paclitaxel.
- Conditions
- HER2-positive Breast Cancer, HER2 Low, SYD-985, SYD985
- Trial name
- NCT04602117
- Testing
- Vic-trastuzumab duocarmazine (SYD985) + paclitaxel
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- QuantumLeap Healthcare Collaborative
Triple Negative Breast Cancer, HER2-positive Breast Cancer
Exosome as the Prognostic and Predictive Biomarker in EBC Patients
This study is the experimental study for serial ctDNA and exosome evaluation in EBC patients
- Trial name
- NCT05955521
- Testing
- exosome and ctDNA evaluation
- Where
- South Korea
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Breast Cancer Stage I, Breast Cancer Stage II
Role of Triggering Receptor Expressed on Myeloid Cells (TREM-1) as a Novel Biomarker in Human Epidermal Growth Factor Receptor -2 (HER-2) Negative Breast Cancer: a Molecular and Clinical Study
Global cancer statistics by world region for the year 2022 estimated breast cancer the 2nd cause of new cancer cases (11.6%). (1) Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth…
- Conditions
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Invasive
- Trial name
- NCT06950671
- Where
- Egypt
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Rahma Esam Salama Esawi
TNBC - Triple-Negative Breast Cancer
Targeting Metastatic Breast Cancers by Alkaline Glucosodiene Molecules Via a Metabolic Pathway Phase I Clinical Trial
The diverse group of breast tumors known as triple-negative breast cancer (TNBC) which is lethally and deadly type of breast cancer and insensitive to endocrine therapy and HER2-targeted therapy because it lacks the expression of…
- Trial name
- NCT05957939
- Testing
- Alkaline Glucosodiene Molecules
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Breast Cancer
A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with…
- Trial name
- NCT07207070
- Testing
- JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution
- Where
- 2 sites in China
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Risen (Suzhou) Pharma Tech Co., Ltd.
Breast Cancer Female
Conformal Ablative Radiotherapy in Older Women (CARMEN) With Breast Cancer Undergoing Non-Operative Management
This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement.
- Trial name
- CARMEN (NCT07242118)
- Testing
- SABR
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Locally Recurrent and Metastatic Breast Cancer
Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment…
- Trial name
- NCT00511459
- Testing
- AMG 386, Bevacizumab, Paclitaxel
- Where
- 77 sites in United States, Australia and 11 more
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Amgen
Breast Cancer Female
Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer
This study is investigating the biological characteristics of early oestrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) in older woman (aged > 70 years) who were treated…
- Trial name
- BOLD-70 (NCT05734950)
- Testing
- Translational study
- Where
- United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Royal Marsden NHS Foundation Trust
Metastatic HR+/HER2- Breast Cancer
Rash & Diarrhea Prophylaxis With Capivasertib
This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone…
- Trial name
- SAFE-CAP (NCT07426822)
- Testing
- Capivasertib, Loperamide, Fulvestrant
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Maryam Lustberg