Clinical trials: Human Epidermal Growth Factor Receptor 2 Negative Tumor
HER2 Negative Breast Cancer
Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer
The investigators propose a randomized phase II study evaluating the pCR and toxicity profiles of combination eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC) as neoadjuvant therapy for locally advanced…
- Trial name
- NCT01527487
- Testing
- Eribulin, Cyclophosphamide, Docetaxel
- Where
- 15 sites in United States
- Volunteers
- 76 people
- Sponsor
- SCRI Development Innovations, LLC
Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
ME-344 in Early HER2-negative Breast Cancer With Antiangiogenic-induced Mitochondrial Metabolism
Prospective, randomized, open label, two arms,, phase 0 clinical trial. HER2-negative breast cancer patients recently diagnosed will be screened for trial participation.
- Conditions
- Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Early-Stage Breast Carcinoma
- Trial name
- NCT02806817
- Testing
- ME-344, Bevacizumab, Normal saline
- Where
- 5 sites in Spain
- Volunteers
- 40 people
- Sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS III
Breast Cancer
Investigating the Metabolic Pathways in Hormone Receptor Positive/HER2 Negative Breast Cancer
To analyze the metabolic activity of Hormone Receptor Positive (HR+)/Her 2 Negative (Her2-) Breast cancer.
- Trial name
- NCT05736367
- Testing
- U-13C-glucose
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Rutgers, The State University of New Jersey
Metastatic Breast Cancer
SU11248 as Consolidation After Response to Taxanes in Metastatic Breast Cancer
This study tests the hypothesis that SU11248 can delay tumor progression after tumor mass reduction by taxanes. This is a dual-arm open-label randomized multicenter phase II clinical trial with 2:1 randomization evaluating the…
- Trial name
- NCT00270413
- Testing
- SU11248
- Where
- 13 sites in Belgium
- Volunteers
- 19 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Breast Cancer
A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors
Ciclibiome is a prospective study including BC patients starting treatment with a CDK4/6 inhibitor (in the metastatic and in the adjuvant setting).
- Trial name
- CICLIBIOME (NCT06171360)
- Where
- 3 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Breast Cancer
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint.
- Trial name
- NCT00127933
- Testing
- capecitabine [Xeloda], Taxotere, Herceptin (HER2-neu positive patients only)
- Where
- 38 sites in United States
- Volunteers
- 157 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.
Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer
Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors
The primary objectives of this study are as follows: Phase 1 (sequential dose-escalation): to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent and to determine the recommended Phase 2 dose…
- Conditions
- Advanced Solid Tumor, Metastatic Triple-Negative Breast Cancer, HR+/HER2- Metastatic Breast Cancer, Metastatic Urothelial Cancer
- Trial name
- ASCENT-J02 (NCT05101096)
- Testing
- Sacituzumab Govitecan-hziy
- Where
- 36 sites in Japan
- Volunteers
- 135 people
- Sponsor
- Gilead Sciences
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
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Advanced or Metastatic Breast Cancer
Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
This is a multi-center, open-label, non-randomized, phase I study
- Trial name
- LeeBLet (NCT02154776)
- Testing
- LEE011, Buparlisib, Letrozole
- Where
- 6 sites in United States, Spain
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With Metastatic Breast Cancer
Target Population: female patients with HER2-negative, ER and/or PgR positive breast cancer in progression after first-line hormonal therapy.
- Trial name
- NCT01477060
- Testing
- Lapatinib, Metformin
- Where
- 11 sites in Italy
- Volunteers
- 32 people
- Sponsor
- Fondazione Michelangelo
Breast Cancer, Breast Carcinoma
A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)
Background: Breast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat.
- Conditions
- Breast Cancer, Breast Carcinoma, Cancer of the Breast, Malignant Neoplasm of Breast
- Trial name
- NCT07067138
- Testing
- Expression Networks for highLIGHting Tumor vulnerabilities (ENLIGHT), TruSight(R) Oncology 500, TruSeq Matched Tumor Normal Whole Exome Sequencing Assay
- Where
- United States
- Volunteers
- 175 people
- Sponsor
- National Cancer Institute (NCI)
Gastric or Gastroesophageal Junction(GEJ) Adenocarcinoma
A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC
A phase II clinical study of trastuzumab in combination with capecitabine and cisplatin (XP) in patients with tissue HER2-negative but serum HER2-positive advanced gastric cancer
- Trial name
- NCT04309578
- Testing
- Trastuzumab, Capecitabine and Cisplatin
- Where
- South Korea
- Volunteers
- 28 people
- Sponsor
- Asan Medical Center
Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8
Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body
This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a…
- Conditions
- Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8
- Trial name
- NCT04248452
- Testing
- Capecitabine, Fluorouracil, Leucovorin
- Where
- 453 sites in United States
- Volunteers
- 314 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
Breast Cancer
A Study to Learn About the Study Medicine PF-07220060 Together With Letrozole Compared to Letrozole Alone in Women Post Menopause
The purpose of this study is to learn about the effects of the study medicine PF-07220060 plus letrozole, compared with the effects of taking letrozole alone without PF-07220060 for treatment of breast cancer.
- Trial name
- NCT06465368
- Testing
- PF-07220060, letrozole
- Where
- 51 sites in United States, Australia and 11 more
- Volunteers
- 121 people
- Sponsor
- Pfizer
HER2-negative Breast Cancer
AT Versus TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer
This is a prospective, randomized and open-label phase II study, evaluating the efficacy and safety of AT vs TP regimen as neoadjuvant treatment for early HER2-negative breast cancer.
- Trial name
- NCT04499118
- Testing
- AT regimen, TP regimen
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Sichuan Provincial People's Hospital
Advanced HR+ HER2 Negative Breast Carcinoma
Advanced Breast Cancer Study of CDK4/6 Inhibitor Combined With Endocrine Therapy Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
By retrospectively collecting and arranging real-world data of multi-center HR+/HER2- advanced breast cancer in China combined with CDK4/6 inhibitor and endocrine therapy, we analyzed different HER2 expression levels (HER2 0, 1+…
- Trial name
- NCT05295043
- Testing
- (CDK)4/6 inhibitor
- Volunteers
- 500 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Fasting Mimicking Diet, Breast Cancer
DIetary REstriction as an Adjunct to Neoadjuvant ChemoTherapy for HER2 Negative Breast Cancer
Preclinical studies provide strong support for the concept that fasting evokes resistance to multiple forms of stress. Fasting reduces plasma levels of growth factors and modulates intracellular nutrient sensing systems, thereby…
- Conditions
- Fasting Mimicking Diet, Breast Cancer, Neoadjuvant Chemotherapy, Pathological Complete Response
- Trial name
- DIRECT (NCT02126449)
- Testing
- Fasting mimicking diet
- Where
- 15 sites in Netherlands
- Volunteers
- 131 people
- Sponsor
- Leiden University Medical Center
Breast Neoplasms
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone…
- Trial name
- NCT04895358
- Testing
- pembrolizumab, paclitaxel, nab-paclitaxel
- Where
- 256 sites in United States, Argentina and 29 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
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