Clinical trials: HER2 Negative Breast Cancer
Advanced Unresectable, Metastatic
Biomarker-Guided Dual-Target CAR-T Cells for Advanced Solid Tumors
This is a multicenter, open-label, Phase 1/2 master protocol evaluating autologous dual-target CAR-T cell therapy in adults with advanced solid cancers.
- Trial name
- SELECT-2CAR (NCT07523529)
- Testing
- Autologous dual-target CAR-T cells selected from the predefined target library., Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Beijing Biotech
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
A Study of PF-06873600 in People With Cancer
The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer.
- Trial name
- NCT03519178
- Testing
- PF-06873600, Endocrine Therapy 1, Endocrine Therapy 2
- Where
- 54 sites in United States, Bulgaria and 4 more
- Volunteers
- 155 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
Breast Cancer
A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer.
- Trial name
- NCT00846027
- Testing
- Bevacizumab, Paclitaxel, Gemcitabine
- Where
- 23 sites in Spain
- Volunteers
- 90 people
- Sponsor
- Hoffmann-La Roche
Advanced Estrogen Receptor Positive HER2- Breast Cancer
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD)…
- Trial name
- NCT02983604
- Testing
- GS-5829, Exemestane, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Gilead Sciences
Neoplasms, Breast
Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer
Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole
- Trial name
- NCT00422903
- Testing
- lapatinib, letrozole
- Where
- 14 sites in Italy, Spain
- Volunteers
- 92 people
- Sponsor
- GlaxoSmithKline
Advanced Breast Cancer
SHIELD: Surveillance of HR+/HER2- : Implementing ESR1m Long-term Monitoring and Detection in 1L aBC
This is a multicountry, multicenter, observational study in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer receiving first-line endocrine-based therapy with an…
- Trial name
- SHIELD (NCT07701070)
- Testing
- Blood sampling
- Volunteers
- 3,000 people
- Sponsor
- AstraZeneca
Breast Cancer
Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer
This Phase I/II study is designed to assess the safety and therapeutic effect of INCB007839 in combination with trastuzumab and vinorelbine in patients with metastatic HER2+ breast cancer.
- Trial name
- NCT01254136
- Testing
- INCB007839 300mg BID, Trastuzumab, Vinorelbine
- Where
- 14 sites in United States
- Volunteers
- 20 people
- Sponsor
- Incyte Corporation
Metastatic Breast Cancer
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-)…
- Trial name
- ELCIN (NCT05596409)
- Testing
- Elacestrant
- Where
- 22 sites in United States, Brazil and 4 more
- Volunteers
- 61 people
- Sponsor
- Stemline Therapeutics, Inc.
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with…
- Trial name
- NCT04546009
- Testing
- Giredestrant, Letrozole, Palbociclib
- Where
- 255 sites in United States, Argentina and 28 more
- Volunteers
- 992 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Evaluate the Antitumor Activity and Safety of IPI-504 in Patients With Advanced Breast Cancer
To evaluate the antitumor activity following treatment with IPI-504 in patients with breast cancer.
- Trial name
- NCT00627627
- Testing
- IPI-504
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- MedImmune LLC
Breast Cancer
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment.
- Trial name
- NCT06126003
- Testing
- Observation
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BioCorteX Inc
Breast Cancer
Study of Zelenectide Pevedotin in Participants With Advanced Breast Cancer
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with NECTIN4-amplified recurrent, unresectable, or metastatic breast cancer who have received…
- Trial name
- NCT06840483
- Testing
- Zelenectide pevedotin (BT8009)
- Where
- 18 sites in United States, Australia and 5 more
- Volunteers
- 66 people
- Sponsor
- BicycleTx Limited
HER2-positive Breast Cancer
MagSense® Human Epidermal Growth Factor Receptor 2 (HER2) Imaging Agent (MSH2IA)
This Phase 1b/2 study is designed as an open-label, multicenter, 3 group, interventional study in which Phase 1b will evaluate the pharmacokinetics (PK) of MSH2IA and Phase 2 will confirm lowest effective dose as well as evaluate…
- Trial name
- NCT07885683
- Testing
- The MagSense® HER2 Imaging Agent (MSH2IA)
- Volunteers
- 70 people
- Sponsor
- Imagion Biosystems, Inc.
HER2-negative Metastatic Breast Cancer
A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer
This was an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in combination with niraparib: Part A is dose…
- Trial name
- NCT05261269
- Testing
- DAN-222, Niraparib
- Where
- 9 sites in United States
- Volunteers
- 30 people
- Sponsor
- Dantari, Inc.
Hormone Receptor Positive HER-2 Negative Breast Cancer
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
This is a Phase II Study of HLX43 in Hormone Receptor Positive，HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care.
- Trial name
- NCT07459738
- Testing
- HLX43
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech
Metastatic Triple Negative Breast Cancer
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and…
- Trial name
- NCT03330847
- Testing
- Olaparib Continuous (28-Day cycle) 300 mg BD., Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle)., Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).
- Where
- 141 sites in United States, Belgium and 13 more
- Volunteers
- 273 people
- Sponsor
- AstraZeneca
HR-positive, HER2-negative Breast Neoplasms
To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer
A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant…
- Trial name
- NCT05365178
- Testing
- TQB3616 capsule, Fulvestrant injection
- Where
- 88 sites in China
- Volunteers
- 432 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Advanced ER+, HER2-Negative Breast Cancer
A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
- Trial name
- NCT02338349
- Testing
- Elacestrant
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen…
- Trial name
- NCT05293964
- Testing
- SIM0270, Palbociclib, everolimus
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.