Clinical trials: HER2-negative Metastatic Breast Cancer
Breast Cancer
Trial of Fulvestrant, MK-0646, and Dasatinib for Metastatic Hormone Receptor-Positive HER2-Negative Breast Cancer
The goals of this clinical research study are to learn the tolerable and effective doses of the drug MK-0646 that can be given in combination with Sprycel (dasatinib) and Faslodex (fulvestrant) to patients with hormone…
- Trial name
- NCT00903006
- Testing
- Fulvestrant, MK-0646, Dasatinib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Neoplasms
Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer
This is a pilot phase 1b study to investigate the safety and side effects of combining the ROR1-targeting monoclonal antibody, cirmtuzumab, with paclitaxel for patients with HER2 negative, metastatic breast cancer.
- Trial name
- NCT02776917
- Testing
- Cirmtuzumab + Paclitaxel
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Barbara Parker, MD
Breast Cancer
NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer
This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer. The drugs involved in this study are: Nivolumab (Opdivo ®) Ipilimumab (Yervoy ®)
- Trial name
- NCT03789110
- Testing
- Nivolumab, Ipilimumab
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of…
- Trial name
- NCT04460911
- Where
- United States
- Volunteers
- 317 people
- Sponsor
- Pfizer
Breast Neoplasm
Cetuximab and Cisplatin in the Treatment of "Triple Negative" (Estrogen Receptor [ER] Negative, Progesterone Receptor [PgR] Negative, and Human Epidermal Growth Factor Receptor 2 [HER2] Negative) Metastatic Breast Cancer
The primary objective of this study is to determine whether overall response to cetuximab combined with cisplatin is better than overall response to cisplatin alone together with showing that the overall response for cetuximab…
- Trial name
- BALI-1 (NCT00463788)
- Testing
- cetuximab, cisplatin, cisplatin
- Where
- 46 sites in Australia, Austria and 9 more
- Volunteers
- 181 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Metastatic Breast Cancer
Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel in patients with previously untreated, locally…
- Trial name
- NCT01663727
- Testing
- Bevacizumab [Avastin], Paclitaxel
- Where
- 178 sites in United States, Argentina and 14 more
- Volunteers
- 481 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
This phase II trial studies how well mirvetuximab soravtansine works as first line in treating patients with triple negative breast cancer.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Trial name
- NCT03106077
- Testing
- Mirvetuximab Soravtansine
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- M.D. Anderson Cancer Center
Metastatic Breast Cancer
A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2…
- Trial name
- NCT02163694
- Testing
- Veliparib, Carboplatin, Paclitaxel
- Where
- 219 sites in United States, Argentina and 35 more
- Volunteers
- 513 people
- Sponsor
- AbbVie
Edema, Erythema
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
This phase II trial studies how well pembrolizumab works in treating patients with stage IV inflammatory breast cancer or triple-negative breast cancer that has spread to other places in the body (metastatic) or has come back…
- Conditions
- Edema, Erythema, Estrogen Receptor Negative, HER2/Neu Negative
- Trial name
- NCT02411656
- Testing
- Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine…
- Trial name
- NCT05104866
- Testing
- Dato-DXd, Capecitabine, Gemcitabine
- Where
- 167 sites in United States, Argentina and 18 more
- Volunteers
- 732 people
- Sponsor
- AstraZeneca
Estrogen Receptor Negative, HER2/Neu Negative
Eribulin Mesylate and Everolimus in Treating Patients With Triple-Negative Metastatic Breast Cancer
This phase I/IB trial studies the side effects and best dose of eribulin mesylate and everolimus in treating patients with breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human…
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor-negative, Stage IV Breast Cancer
- Trial name
- NCT02120469
- Testing
- everolimus, eribulin mesylate, pharmacological study
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- City of Hope Medical Center
Estrogen Receptor Negative, HER2/Neu Negative
Tivantinib in Treating Patients With Recurrent or Metastatic Breast Cancer
This phase II trial studies how well tivantinib works in treating patients with recurrent or metastatic breast cancer. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Recurrent Breast Carcinoma
- Trial name
- NCT01575522
- Testing
- Laboratory Biomarker Analysis, Tivantinib
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Phase II Study of Pembrolizumab and Nab-paclitaxel in HER-2 Negative Metastatic Breast Cancer
This is a single-arm open-label multi-cohort Phase II study evaluating the safety/tolerability and clinical activity of the combination of nab-paclitaxel and the antibody against programmed cell death 1 (PD-1), pembrolizumab, in…
- Trial name
- NCT02752685
- Testing
- Pembrolizumab, Nab-Paclitaxel
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- NYU Langone Health
Triple Negative Breast Cancer, Stage IV Breast Cancer
Carboplatin With or Without Atezolizumab in Treating Patients With Stage IV Triple Negative Breast Cancer
This randomized phase II trial studies how well carboplatin with or without atezolizumab works in treating patients with stage IV triple negative breast cancer.
- Conditions
- Triple Negative Breast Cancer, Stage IV Breast Cancer, HER2 Negative, Invasive Breast Cancer
- Trial name
- NCT03206203
- Testing
- Atezolizumab, Carboplatin, Laboratory Biomarker
- Where
- 6 sites in United States
- Volunteers
- 106 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Estrogen Receptor Negative Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer
This phase I/II trial study evaluates the tolerability and best tolerated dose of the PI3K inhibitor GDC-0941 when given with the chemotherapy cisplatin.
- Conditions
- Estrogen Receptor Negative Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Triple Negative Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT01918306
- Testing
- cisplatin, laboratory biomarker analysis, pharmacological study
- Where
- 16 sites in United States
- Volunteers
- 11 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Hormone Receptor Positive Breast Cancer
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2…
- Trial name
- BOLERO-4 (NCT01698918)
- Testing
- Everolimus, Letrozole, Exemestane
- Where
- 52 sites in United States, Argentina and 11 more
- Volunteers
- 202 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Metastatic Breast Cancer
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- OASIS (NCT04720664)
- Testing
- SM-88
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Georgetown University
Advanced Breast Cancer
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on…
- Trial name
- BOLERO-5 (NCT03312738)
- Testing
- Everolimus, Exemestane
- Where
- 15 sites in China
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals