Clinical trials: Her2-negative Metastatic Breast Cancer
Breast Cancer
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
- Trial name
- CONTESSA (NCT03326674)
- Testing
- Tesetaxel and Capecitabine, Capecitabine
- Where
- 207 sites in United States, Australia and 17 more
- Volunteers
- 685 people
- Sponsor
- Odonate Therapeutics, Inc.
Metastatic Breast Cancer
Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients
The objective of this phase II study is to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five patients will be enrolled into this study.
- Trial name
- NCT01658033
- Testing
- Avastin + mFOLFOX6
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Fudan University
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer.
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer
- Trial name
- NCT01791478
- Testing
- PI3K inhibitor BYL719, letrozole, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
HER2-negative Breast Cancer, Leptomeningeal Metastasis
Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination…
- Trial name
- NCT06230055
- Testing
- Ommaya reservoir, Systematic chemotherapy, Intrathecal chemotherapy
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Fudan University
Prostate Cancer Metastatic, Advanced Breast Cancer
Safety and Pharmacokinetics of ODM-209
The purpose of this first-in-human study is to evaluate safety and tolerability of ODM-209 and find the dose of ODM-209.
- Conditions
- Prostate Cancer Metastatic, Advanced Breast Cancer, Castration-resistant Prostate Cancer, Metastatic Breast Cancer
- Trial name
- STESIDES (NCT03878823)
- Testing
- ODM-209
- Where
- 4 sites in Denmark, Finland and 1 more
- Volunteers
- 38 people
- Sponsor
- Orion Corporation, Orion Pharma
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 Metastatic, Locally Advanced Breast Cancer (LABC)
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer.
- Conditions
- Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC), Malignant Neoplasm of Breast, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT06878248
- Testing
- Two Component Product CLBR001 + ABBV-461
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Calibr, a division of Scripps Research
Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed…
- Conditions
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05573126
- Testing
- EP0062, Elacestrant, Everolimus
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Ellipses Pharma
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer
Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced, Metastatic, or Recurrent Triple Negative Invasive Breast Cancer
This phase II clinical trial studies how well gamma-secretase/Notch signalling pathway inhibitor RO4929097 works in treating patients with advanced, metastatic, or recurrent triple negative invasive breast cancer.
- Conditions
- Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Male Breast Cancer, Progesterone Receptor-negative Breast Cancer
- Trial name
- NCT01151449
- Testing
- gamma-secretase/Notch signalling pathway inhibitor RO4929097, laboratory biomarker analysis
- Where
- 2 sites in Canada
- Volunteers
- 6 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
Choice Of the Most Active Strategies for Short term recurring Triple Negative Breast Cancer: A phase Ib/II, open-label, modular, dose-finding and dose-expansion study to explore safety, tolerability, pharmacokinetics, and…
- Trial name
- COMPASS-TNBC (NCT06508216)
- Testing
- Dato-DXd, Durvalumab
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Advanced Breast Cancer
A Study of SHR6390 in Combination With Letrozole or Anastrozole or Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant.
- Trial name
- NCT03481998
- Testing
- SHR6390, Letrozole or anastrozole or Fulvestrant
- Where
- 4 sites in China
- Volunteers
- 104 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Adult Solid Neoplasm, Estrogen Receptor Negative
Veliparib in Combination With Carboplatin and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Solid Tumors
This phase I clinical trial studies the side effects and the best dose of veliparib when given together with carboplatin and paclitaxel in treating patients with locally advanced or metastatic solid tumors.
- Conditions
- Adult Solid Neoplasm, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative
- Trial name
- NCT01281150
- Testing
- Carboplatin, Laboratory Biomarker Analysis, Paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in…
- Trial name
- NCT01942135
- Testing
- Palbociclib, Fulvestrant
- Where
- 247 sites in United States, Australia and 15 more
- Volunteers
- 521 people
- Sponsor
- Pfizer
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)
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human…
- Trial name
- NCT04576455
- Testing
- Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00834678
- Testing
- bendamustine, erlotinib, Maintenance erlotinib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Breast Cancer, HR-positive Breast Cancer
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment
This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+/HER2- advanced breast cancer and progression on prior endocrine-based treatment. The goal of this study is 1.
- Conditions
- Breast Cancer, HR-positive Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- CAPIcorn (NCT07281833)
- Testing
- Capivasertib
- Where
- 16 sites in Belgium, Germany and 1 more
- Volunteers
- 250 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer
DWI in Assessing Treatment Response in Patients With Breast Cancer Receiving Neoadjuvant Chemotherapy
RATIONALE: Imaging procedures, such as diffusion-weighted magnetic resonance imaging (DWI) and dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), may help in evaluating how well patients with breast cancer respond to…
- Trial name
- ACRIN6698 (NCT01564368)
- Testing
- diffusion-weighted magnetic resonance imaging
- Where
- 7 sites in United States
- Volunteers
- 406 people
- Sponsor
- American College of Radiology Imaging Network
Breast Carcinoma
ECLECTIC: EstroTEP and Circulating Biomarkers for ER-positive HER2-negative Metastatic Breast Cancer Patients
Eclectic is a strategy trial; once the class of treatment (endocrine therapy or chemotherapy) has been allocated according to 16α-18F-fluoro-17β-oestradiol (18F-FES) Positron Emission Tomography/Computed Tomography (PET/CT)…
- Trial name
- ECLECTIC (NCT06195709)
- Testing
- Endocrine therapy, Endocrine therapy combined with the local treatment of FES-negative lesions, Chemotherapy
- Where
- 21 sites in France
- Volunteers
- 300 people
- Sponsor
- Institut Curie
Estrogen Receptor-Positive, HER2-Negative
ER+/HER2- Locally Advanced or Metastatic Breast Cancer (ENZENO Study)
For patients with ER-positive, HER2-negative breast cancer, blockage of the ER pathway has been proven to be an effective anticancer approach. These patients showed good response to endocrine therapy.
- Conditions
- Estrogen Receptor-Positive, HER2-Negative, Locally Advanced Breast Cancer, Metastatic Breast Cancer
- Trial name
- ENZENO (NCT04669587)
- Testing
- ZB716, Palbociclib
- Where
- 8 sites in United States, South Korea
- Volunteers
- 106 people
- Sponsor
- EnhancedBio USA Inc.