Clinical trials: HER2 Negative Breast Neoplasms
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal…
- Trial name
- SOLAR-1 (NCT02437318)
- Testing
- Fulvestrant, Alpelisib
- Where
- 197 sites in United States, Argentina and 29 more
- Volunteers
- 572 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast Cancer
This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery.
- Trial name
- NCT02520063
- Testing
- Letrozole, Everolimus, TRC105
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Alabama at Birmingham
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)
This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT05554354
- Testing
- Binimetinib, Biopsy Procedure, Biospecimen Collection
- Where
- 196 sites in United States, Puerto Rico
- Volunteers
- 1 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk…
- Trial name
- CheckMate 7FL (NCT04109066)
- Testing
- nivolumab, paclitaxel (PTX), anthracycline
- Where
- 240 sites in United States, Argentina and 30 more
- Volunteers
- 521 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer
RATIONALE: Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells.
- Trial name
- NCT01105312
- Testing
- letrozole, panobinostat, RNA analysis
- Where
- 172 sites in United States
- Volunteers
- 28 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Metastatic Breast Cancer
Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer
The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer.
- Trial name
- NCT00597597
- Testing
- Erlotinib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Rush University Medical Center
Estrogen Receptor Negative, HER2/Neu Negative
Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer…
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative
- Trial name
- NCT02445391
- Testing
- Capecitabine, Carboplatin, Cisplatin
- Where
- 1,024 sites in United States, South Africa
- Volunteers
- 415 people
- Sponsor
- ECOG-ACRIN Cancer Research Group
Breast Cancer
Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole.
- Trial name
- AMEERA-4 (NCT04191382)
- Testing
- Amcenestrant (SAR439859), Letrozole
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 105 people
- Sponsor
- Sanofi
Breast Cancer
Breast Cancer Study of Preoperative Pembrolizumab + Radiation
This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the…
- Trial name
- NCT03366844
- Testing
- Pembrolizumab, RT Boost
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Stephen Shiao
Breast Cancer, Early-stage Breast Cancer
TRADE: Dose Escalation Tolerability of Abemaciclib in HR+ HER2- Early Stage Breast Cancer
In this research study, investigators are testing if a dose-increasing strategy for abemaciclib will have less side effects and be better tolerated than the standard dosage of abemaciclib for participants with early-stage…
- Conditions
- Breast Cancer, Early-stage Breast Cancer, High Risk Breast Carcinoma
- Trial name
- NCT06001762
- Testing
- Abemaciclib, Tamoxifen, Anastrozole
- Where
- 12 sites in United States
- Volunteers
- 90 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer
Investigate the use of BYL719 (alpelisib) as combination therapy with Nab-Paclitaxel in locally recurrent or metastatic HER-2 negative breast cancer.
- Trial name
- NCT02379247
- Testing
- BYL-719 (alpelisib), Nab-paclitaxel
- Where
- 4 sites in United States
- Volunteers
- 43 people
- Sponsor
- Priyanka Sharma
Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
This randomized phase I/II trial studies the side effects and the best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with whole-brain radiation therapy or stereotactic…
- Conditions
- Adult Solid Neoplasm, Extensive Stage Lung Small Cell Carcinoma, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT01217411
- Testing
- Cognitive Assessment, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
PALbociclib CoLlaborative Adjuvant Study
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early…
- Trial name
- PALLAS (NCT02513394)
- Testing
- Palbociclib, Standard Adjuvant Endocrine Therapy
- Where
- 437 sites in United States, Australia and 19 more
- Volunteers
- 5,796 people
- Sponsor
- Alliance Foundation Trials, LLC.
Breast Cancer Metastatic
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination…
- Trial name
- NCT05155566
- Where
- 2 sites in Argentina, United Kingdom
- Volunteers
- 847 people
- Sponsor
- Pfizer
Breast Neoplasms
An Open Label Phase II Trial of BIBW 2992 in Patients With HER2-negative Metastatic Breast Cancer
The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more…
- Trial name
- NCT00425854
- Testing
- BIBW 2992
- Where
- 14 sites in Belgium, Germany
- Volunteers
- 50 people
- Sponsor
- Boehringer Ingelheim
Breast Cancer, Breast Carcinoma
Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer
The goal of this clinical research study is to learn if the study drug, alisertib (MLN8237), in combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with hormone receptor (HR)-positive, human…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Tumors, Malignant Neoplasm of Breast
- Trial name
- NCT02187991
- Testing
- Paclitaxel, Alisertib
- Where
- United States
- Volunteers
- 169 people
- Sponsor
- US Oncology Research
Breast Cancer
Study to Evaluate the Efficacy and Safety of Eribulin Mesylate Administered Biweekly (Q2W) for Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer
This is a Phase 2, open-label, single arm, multicenter, 2-stage study of eribulin mesylate administered biweekly at 1.4 mg/m2 intravenously for the treatment of participants with HER2-negative metastatic breast cancer previously…
- Trial name
- NCT02481050
- Testing
- Eribulin Mesylate
- Where
- 12 sites in United States
- Volunteers
- 58 people
- Sponsor
- Eisai Inc.
Estrogen Receptor Positive Breast Cancer
TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer
This is an open label phase II clinical trial to determine the efficacy, toxicity, and safety of TAK-228 plus tamoxifen in patients with newly diagnosed ER-positive, HER2-negative breast cancer.
- Trial name
- ANETT (NCT02988986)
- Testing
- TAK-228, Tamoxifen
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- The Methodist Hospital Research Institute
Estrogen Receptor Negative, Estrogen Receptor Positive
MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer
The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in combination with tremelimumab in patients with metastatic HER2-negative breast cancer.
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Recurrent Breast Carcinoma
- Trial name
- NCT02536794
- Testing
- Anti-B7H1 Monoclonal Antibody MEDI4736, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Northwestern University
Breast Cancer
Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer
The primary objective of this study is to determine the safety and feasibility of combining cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with preoperative chemotherapy.
- Trial name
- NCT02018458
- Testing
- LA TNBC: DC vaccine+Preop chemo, ER+/HER2-BC:DC vaccine+Preop chemo
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Baylor Research Institute