Clinical trials: HER2 Negative Breast Cancer
Primary Invasive Breast Cancer
EndoPredict® Extended Endocrine Trial (EXET)
The purpose of this study is to evaluate the impact of using EndoPredict® clinically to inform treatment decisions for extended endocrine therapy, and the subsequent impact on patient outcomes.
- Trial name
- NCT04016935
- Testing
- Observational
- Where
- 52 sites in United States
- Volunteers
- 855 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
Breast Neoplasms
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone…
- Trial name
- NCT04895358
- Testing
- pembrolizumab, paclitaxel, nab-paclitaxel
- Where
- 256 sites in United States, Argentina and 29 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer
This study to learn more about olaparib and olaparib plus durvalumab combination therapy and also to better understand the studied disease, breast cancer, and associated health problems.
- Trial name
- OlympiaN (NCT05498155)
- Testing
- Neoadjuvant Olaparib monotherapy group, Neoadjuvant combination therapy with olaparib plus durvalumab
- Where
- 36 sites in United States, Australia and 7 more
- Volunteers
- 50 people
- Sponsor
- AstraZeneca
Her2 Negative Breast Cancer Patients
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone
- Trial name
- NCT01151046
- Testing
- MM-121, Exemestane
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 118 people
- Sponsor
- Merrimack Pharmaceuticals
Breast Cancer
Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative…
- Trial name
- NCT06702618
- Testing
- TQB3616 capsule+Fulvestrant Injection
- Where
- 13 sites in China
- Volunteers
- 33 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer Metastatic
DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer
DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who…
- Trial name
- NCT04509596
- Testing
- DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C
- Where
- 3 sites in United States, China
- Volunteers
- 23 people
- Sponsor
- Dizal Pharmaceuticals
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
Advanced Solid Tumor, Cholangiocarcinoma
To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors
This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors (solid tumor, BTC and…
- Conditions
- Advanced Solid Tumor, Cholangiocarcinoma, Biliary Tract Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05253053
- Testing
- TT-00420, Combination Product: Atezolizumab, Combination Product: Nab-Paclitaxel
- Where
- 9 sites in China
- Volunteers
- 84 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Advanced Breast Cancer
A Clinical Trial of TQB3909 Tablets in Patients With Breast Cancer
TQB3909 is an inhibitor targeting B-cell lymphoma (BCL)-2 protein. By binding to BCL-2 protein, TQB3909 releases Pro apoptotic proteins such as BCL-2-Anatagonist/Killer 1(BAK), BCL-2 associated X (BAX) protein and BCL-2…
- Trial name
- NCT05775575
- Testing
- TQB3909 tablets
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Advanced Breast Cancer Female
Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate
The purpose of this study is to provide access to palbociclib in Mexico and in selected Latin American countries before it becomes commercially available to patients with HR positive/HER2-negative ABC who are appropriate…
- Trial name
- NCT02600923
- Testing
- Palbociclib, Letrozole
- Where
- 24 sites in Argentina, Brazil and 2 more
- Volunteers
- 131 people
- Sponsor
- Pfizer
Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.
- Trial name
- NCT01446159
- Testing
- MEDI-573, Aromatase Inhibitor
- Where
- 71 sites in United States, Belgium and 9 more
- Volunteers
- 188 people
- Sponsor
- MedImmune LLC
Breast Cancer
A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Participants With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
This was a Phase 1/2 dose escalation and cohort expansion study and assessed the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE®) in participants with estrogen receptor…
- Trial name
- mBC (NCT04072952)
- Testing
- Vepdegestrant, Palbociclib
- Where
- 16 sites in United States
- Volunteers
- 219 people
- Sponsor
- Arvinas Estrogen Receptor, Inc.
Breast Cancer
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in…
- Trial name
- NCT01923168
- Testing
- alpelisib, buparlisib
- Where
- 86 sites in United States, Australia and 15 more
- Volunteers
- 340 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.
- Trial name
- NCT06797635
- Testing
- Patritumab deruxtecan, Pembrolizumab, Paclitaxel
- Where
- 17 sites in United States, South Korea and 2 more
- Volunteers
- 372 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
- Trial name
- DARE (NCT04567420)
- Testing
- Palbociclib, Fulvestrant, Adjuvant Therapy
- Where
- 19 sites in United States
- Volunteers
- 70 people
- Sponsor
- Criterium, Inc.
ER Positive, Her2 Negative Breast Cancer Patients, Triple Negative Breast Cancer Patients
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer…
- Trial name
- NCT01421472
- Testing
- MM-121, Paclitaxel
- Where
- 38 sites in United States
- Volunteers
- 196 people
- Sponsor
- Merrimack Pharmaceuticals
Advanced Solid Tumours, Endometrial Cancer
A Phase 1 Study of [225Ac]-FPI-1434 Injection
This is a first-in-human Phase 1/2, non-randomized, multi-centre, open-label clinical study designed to investigate safety, tolerability, PK, and preliminary anti-tumour activity of [225Ac]-FPI-1434 (radioimmuno-therapeutic…
- Conditions
- Advanced Solid Tumours, Endometrial Cancer, Cervical Cancer, Ovarian Cancer
- Trial name
- NCT03746431
- Testing
- [111In]-FPI-1547 Injection, [225Ac]-FPI-1434 Injection multi-dose, FPI-1175 Infusion
- Where
- 13 sites in United States, Australia and 1 more
- Volunteers
- 78 people
- Sponsor
- Fusion Pharmaceuticals Inc.
ER-Positive, HER2-Negative Breast Cancer
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum…
- Trial name
- NCT04993430
- Testing
- HRS8807, HRS8807、SHR6390
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,466 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
This was a randomized, double-blind, placebo-controlled study conducted in Chinese women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, plus an open-label…
- Trial name
- NCT03671330
- Testing
- Ribociclib, NSAI: Letrozole or Anastrazole, Goserelin
- Where
- 24 sites in China
- Volunteers
- 327 people
- Sponsor
- Novartis Pharmaceuticals