Clinical trials: ER+, HER2-, Metastatic Breast Cancer
Breast Cancer
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with…
- Trial name
- SANDPIPER (NCT02340221)
- Testing
- Taselisib, Fulvestrant
- Where
- 157 sites in United States, Australia and 26 more
- Volunteers
- 631 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer
Women with Hormone Receptor (HR)+ Human Epidermal growth factor Receptor (HER)2- metastatic breast cancer are eligible to a randomized trial.
- Trial name
- CIMER (NCT04220476)
- Testing
- Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions), Letrozole 2.5Mg Tab, Palbociclib 125mg
- Sponsor
- Weill Medical College of Cornell University
Breast Cancer
An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer
The following trial is designed to offer pre-approval drug access to iniparib in combination with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR-, and HER2-negative metastatic…
- Trial name
- NCT01130259
- Testing
- iniparib
- Sponsor
- Sanofi
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Estrogen Receptor Negative, Estrogen Receptor Positive
Taselisib and Enzalutamide in Treating Patients With Androgen Receptor Positive Triple-Negative Metastatic Breast Cancer
This partially randomized phase Ib/II trial studies the side effects and best dose of taselisib when given together with enzalutamide and to see how well they work in treating patients with androgen receptor positive…
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT02457910
- Testing
- Biomarker Analysis, Enzalutamide, Pharmacological Study
- Where
- 12 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Breast Cancer
Phase I Study of the Combination of MLN9708 and Fulvestrant
Participants in this study will have been diagnosed with advanced breast cancer that has become worse while being treated with fulvestrant. Participants will have estrogen-receptor positive disease, and have completed menopause.
- Trial name
- Millennium (NCT02384746)
- Testing
- Fulvestrant, MLN9708
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Neoplasms, Breast
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given…
- Trial name
- Neo ALTTO (NCT00553358)
- Testing
- Lapatinib, Trastuzumab, Paclitaxel
- Where
- 121 sites in Argentina, Belgium and 22 more
- Volunteers
- 455 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Pet Imaging as a Biomarker in Hormone Refractory postmenopausaL Women
This is a prospective, single arm trial in which patients with locally advanced or metastatic endocrine receptor positive and HER2 negative breast cancer refractory to non-steroidal aromatase inhibitors (NSAI) will receive…
- Trial name
- PEARL (NCT02028364)
- Testing
- Everolimus, Exemestane
- Where
- 5 sites in Belgium
- Volunteers
- 55 people
- Sponsor
- Jules Bordet Institute
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Recurrent Breast Cancer
Local Treatment in ER-positive/HER2-negative Oligo-metastatic Breast Cancer
Local treatment in addition to endocrine treatment as 1st line for oligo-metastatic ER-positive/HER2-negative breast cancer.
- Conditions
- Breast Cancer, Recurrent Breast Cancer, Stereotactic Body Radiotherapy, Estrogen Receptor Positive Tumor
- Trial name
- CLEAR (NCT03750396)
- Testing
- Surgical resection, Stereotactic body radiotherapy, Radiofrequency ablation
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- Gangnam Severance Hospital
Estrogen Receptor Negative, Head and Neck Squamous Cell Carcinoma
Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction
This phase I trial studies the side effects and best dose of talazoparib in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or…
- Conditions
- Estrogen Receptor Negative, Head and Neck Squamous Cell Carcinoma, HER2/Neu Negative, Hormone-Resistant Prostate Cancer
- Trial name
- NCT02567396
- Testing
- Laboratory Biomarker Analysis, Pharmacological Study, Talazoparib
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Maximum Tolerated Dose (MTD) of Liposomal Doxorubicin in Combination With Seliciclib for Patients With Metastatic Triple Negative Breast Cancer (TNBC)
The goal of this clinical research study is to find the highest tolerable dose of seliciclib that can be given in combination with liposomal doxorubicin to patients with metastatic breast cancer.
- Trial name
- NCT01333423
- Testing
- Liposomal Doxorubicin, Seliciclib
- Sponsor
- M.D. Anderson Cancer Center
ER+, HER2-, Metastatic Breast Cancer
AZD9833 China PK Study
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer
- Trial name
- AZD9833 (NCT04818632)
- Testing
- AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus
- Where
- 4 sites in China
- Volunteers
- 28 people
- Sponsor
- AstraZeneca
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, Hematologic Neoplasms
Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients
This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose.
- Trial name
- NCT00526045
- Testing
- AUY922 2 mg/m2
- Where
- 10 sites in United States, Netherlands and 2 more
- Volunteers
- 117 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)].
- Trial name
- VERU-024 (NCT05065411)
- Testing
- Enobosarm & Abemaciclib Combo, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
- Where
- 30 sites in United States
- Volunteers
- 5 people
- Sponsor
- Veru Inc.
Metastatic Triple Negative Breast Cancer
Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer
This study will evaluate the effectiveness and safety of the combination of two drugs, Veliparib and Lapatinib, given to participants with metastatic triple negative breast cancer that have undergone previous treatment.
- Trial name
- NCT02158507
- Testing
- Combination of Veliparib + Lapatinib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer
Veliparib, Cisplatin, and Vinorelbine Ditartrate in Treating Patients With Recurrent and/or Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of veliparib when given together with cisplatin and vinorelbine ditartrate in treating patients with breast cancer that has returned or spread to other parts of the body.
- Conditions
- Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Hereditary Breast/Ovarian Cancer - BRCA1, Hereditary Breast/Ovarian Cancer - BRCA2
- Trial name
- NCT01104259
- Testing
- veliparib, cisplatin, vinorelbine tartrate
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Washington
ER+, HER2- Advanced Breast Cancer, Metastatic Breast Cancer
Study of TFX06 in Women With Advanced Breast Cancer.
A Phase 1/2 Dose Escalation and Expansion Study of TFX06 tablet Alone in Women with ER Positive, HER2 Negative Advanced Breast Cancer
- Trial name
- NCT05927779
- Testing
- TFX06 tablet
- Where
- 2 sites in China
- Volunteers
- 74 people
- Sponsor
- Zhejiang Yangli Pharmaceutical Technology Co., Ltd.
Breast Cancer
Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00232505
- Testing
- cetuximab, carboplatin
- Where
- 14 sites in United States
- Volunteers
- 112 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center