Clinical trials: HER2 Negative
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Breast Cancer
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal…
- Trial name
- NCT02561832
- Testing
- Olaparib, Carboplatin, Anthracycline
- Where
- 7 sites in United States, Spain
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity…
- Conditions
- Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative
- Trial name
- DUET-3 (NCT03752398)
- Testing
- XmAb®23104, Yervoy® (ipilimumab)
- Where
- 18 sites in United States
- Volunteers
- 198 people
- Sponsor
- Xencor, Inc.
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Metastatic Breast Cancer
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2…
- Trial name
- NCT01288092
- Testing
- BEZ235
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer
This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer.
- Trial name
- NCT00773695
- Testing
- Aromatase Inhibitor, Bevacizumab, Epirubicine
- Where
- 3 sites in Norway
- Volunteers
- 150 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2…
- Trial name
- NCT02163694
- Testing
- Veliparib, Carboplatin, Paclitaxel
- Where
- 219 sites in United States, Argentina and 35 more
- Volunteers
- 513 people
- Sponsor
- AbbVie
Metastatic Breast Cancer
Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national…
- Trial name
- NCT05132101
- Testing
- Patients who received Palbociclib as first line therapy in MBC setting
- Where
- South Korea
- Volunteers
- 2,758 people
- Sponsor
- Pfizer
Breast Cancer
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen…
- Trial name
- NCT02273973
- Testing
- Letrozole, Taselisib
- Where
- 117 sites in United States, Australia and 20 more
- Volunteers
- 334 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer
This Phase II trial evaluates the safety and immunogenicity of two doses of the Folate Receptor Alpha (FRα) peptide vaccine mixed with GM-CSF as a vaccine adjuvant, with or without a immune priming with cyclophosphamide, as a…
- Trial name
- NCT02593227
- Testing
- Low dose FRα vaccine, Cyclophosphamide, High dose FRα vaccine
- Where
- 11 sites in United States
- Volunteers
- 80 people
- Sponsor
- Marker Therapeutics, Inc.
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer.
- Trial name
- NCT05645536
- Testing
- TOL2506, Tamoxifen, Letrozole tablets
- Where
- 46 sites in United States, Argentina and 4 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Breast Cancer
A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05080842
- Testing
- AC682
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Accutar Biotechnology Inc
Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients aged ≥ 18 years with solid tumors
- Conditions
- Pancreatic Ductal Adenocarcinoma, Non-Small Cell Lung Cancer, HR+/HER2- Ductal and Lobular Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT07261631
- Testing
- 68Ga-NNS309, 177Lu-DFC413
- Where
- 9 sites in United States, Canada and 5 more
- Volunteers
- 180 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast Cancer
This study is a randomized controlled study.The primary objective is to evaluate the Progression-Free Survival(PFS) of Utidelone Capsule combined with Capecitabine compared with Utidelone Injection combined with Capecitabine in…
- Trial name
- NCT07684456
- Testing
- Utidelone Capsule, Utidelone Injection, Capecitabine
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.