Clinical trials: HER2-negative Breast Cancer
Breast Cancer Metastatic
A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations
This research study is evaluating the efficacy and safety of TSL-1502 capsules in patients with breast cancer, will be included HER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations.
- Trial name
- NCT05420779
- Testing
- TSL-1502 capsules(low dose), TSL-1502 capsules(high dose), Investigator's choice of chemotherapy
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
Breast Cancer, Colorectal Cancer
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
- Conditions
- Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
- Trial name
- NCT04172597
- Testing
- Poziotinib Hydrochloride, Loperamide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by…
- Trial name
- NCT00875979
- Testing
- Trastuzumab emtansine [Kadcyla] 3.0 mg/kg, Trastuzumab emtansine [Kadcyla] 3.6 mg/kg, Pertuzumab 420 mg
- Where
- 20 sites in United States, Belgium and 5 more
- Volunteers
- 67 people
- Sponsor
- Hoffmann-La Roche
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
The goal of this study was to determine the effect on overall survival and progression free survival by adding iniparib (BSI-201/SAR240550) to the combination of gemcitabine/carboplatin in adult patients with triple negative…
- Trial name
- NCT00938652
- Testing
- gemcitabine/carboplatin, Iniparib
- Where
- 102 sites in United States
- Volunteers
- 519 people
- Sponsor
- Sanofi
Breast Cancer, Hormone Receptor Positive Tumor
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- INGE-B (NCT02894398)
- Testing
- Palbociclib, Letrozole, Anastrozole
- Where
- 70 sites in Germany
- Volunteers
- 388 people
- Sponsor
- iOMEDICO AG
Breast Cancer, Cancer
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
- Trial name
- CheckMate 7A8 (NCT04075604)
- Testing
- Nivolumab, Anastrozole, Palbociclib
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer, Hormone Receptor Positive Tumor
Ribociclib and Endocrine Therapy or Chemotherapy With or Without Bevacizumab for Metastatic Breast Cancer in First Line
This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or fulvestrant OR capecitabine with bevacizumab OR paclitaxel with / without bevacizumab…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, HER 2 Negative Breast Cancer
- Trial name
- RIBBIT (NCT03462251)
- Testing
- Ribociclib and aromatase inhibitor or fulvestrant, Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab
- Where
- 27 sites in Germany
- Volunteers
- 41 people
- Sponsor
- iOMEDICO AG
Breast Neoplasms
Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated…
- Trial name
- NCT02258451
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Exemestane, Everolimus
- Where
- 92 sites in United States, Austria and 15 more
- Volunteers
- 283 people
- Sponsor
- Bayer
Advanced Breast Cancer
A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer
A study to learn about a new medicine called ARV-471 (PF-07850327) in people who have advanced metastatic breast cancer.
- Trial name
- VERITAC-2 (NCT05654623)
- Testing
- ARV-471, Fulvestrant
- Where
- 312 sites in United States, Argentina and 29 more
- Volunteers
- 624 people
- Sponsor
- Pfizer
Advanced Solid Tumor, HR+/HER2- Breast Cancer
Study of AVZO-021 in Patients With Advanced Solid Tumors
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification
- Trial name
- NCT05867251
- Testing
- AVZO-021, Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Australia
- Volunteers
- 430 people
- Sponsor
- Avenzo Therapeutics, Inc.
Breast Cancer
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate…
- Trial name
- NCT03471663
- Testing
- D-0502, palbociclib
- Where
- 15 sites in United States, China
- Volunteers
- 200 people
- Sponsor
- InventisBio Co., Ltd
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 18 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
Breast Cancer
Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating a drug called AC699 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05654532
- Testing
- AC699
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Accutar Biotechnology Inc
Advanced or Metastatic Breast Cancer
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with…
- Trial name
- NCT05187832
- Testing
- AND019 PO QD
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Kind Pharmaceuticals LLC
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in…
- Trial name
- INAVO123 (NCT06790693)
- Testing
- Inavolisib, CDK4/6i, Letrozole
- Where
- 242 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
ER+ HER2- Advanced Breast Cancer
A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to…
- Trial name
- NCT04541433
- Testing
- AZD9833
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Breast Cancer
Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC
CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC).
- Trial name
- CONTESSA TRIO (NCT03952325)
- Testing
- Tesetaxel, Nivolumab, Pembrolizumab
- Where
- 12 sites in United States, Singapore and 1 more
- Volunteers
- 294 people
- Sponsor
- Odonate Therapeutics, Inc.
Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)
- Trial name
- DUAL-NK-BC (NCT07486089)
- Testing
- Dual-target CAR-NK cells (EB-DT-CAR-NK), Lymphodepleting chemotherapy, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Breast Neoplasm
Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin…
- Trial name
- PRECYCLE (NCT03220178)
- Testing
- Palbociclib, Fulvestrant, Anastrozole
- Where
- Germany
- Volunteers
- 532 people
- Sponsor
- Palleos Healthcare GmbH