Clinical trials: HER2 Negative Breast Cancer
Locally Advanced or Metastatic Breast Cancer
Evaluation of Lasofoxifene Versus Fulvestrant in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
This is an open label, randomized, multicenter study evaluating the activity of lasofoxifene relative to fulvestrant for the treatment of pre- and postmenopausal women with locally advanced or metastatic ER+/HER2- breast cancer…
- Trial name
- NCT03781063
- Testing
- Lasofoxifene, Fulvestrant
- Where
- 51 sites in United States, Canada and 1 more
- Volunteers
- 100 people
- Sponsor
- Sermonix Pharmaceuticals Inc.
Advanced Solid Tumor, HER2-negative Breast Cancer
Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HER2-negative Breast Cancer, Metastatic Castration-resistant Prostate Cancer (mCRPC), Pancreatic Cancer
- Trial name
- NCT06334432
- Testing
- NUV-1511
- Where
- 8 sites in United States
- Volunteers
- 466 people
- Sponsor
- Nuvation Bio Inc.
ER-Positive HER2-Negative Breast Cancer
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in…
- Trial name
- SERENA-6 (NCT04964934)
- Testing
- AZD9833, Anastrozole, Letrozole
- Where
- 264 sites in United States, Australia and 21 more
- Volunteers
- 315 people
- Sponsor
- AstraZeneca
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
Disease Progression
Treatment Resistance Following Anti-cancer Therapies
The TRANSLATE study aims to better understand why tumors become resistant to standard anti-cancer therapies. New tumor biopsy and blood samples are collected after disease progression on standard-of-care anti-cancer treatment and…
- Trial name
- NCT04436120
- Testing
- De novo tumor tissue biopsy, Research blood draws
- Where
- 33 sites in United States, Argentina and 3 more
- Volunteers
- 38 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Clinical Utility of FES F18 PET/CT in Metastatic Breast Cancer Patients
This is a phase 4, multi-center, open-label, prospective cohort study to evaluate the clinical utility of Fluoroestradiol F18 (Cerianna) PET/CT to guide therapeutic management in ER-positive, HER2-negative metastatic breast…
- Trial name
- NCT05068726
- Testing
- 18F Fluoroestradiol Radiopharmaceutical with PET/CT
- Where
- 24 sites in United States
- Volunteers
- 51 people
- Sponsor
- GE Healthcare
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.
Metastatic Breast Cancer, Recurrent Breast Cancer
ModraDoc006/r in Patients With Breast Cancer
This is a multicenter phase IIa study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with recurrent or metastatic HER-2 negative breast cancer, that are…
- Trial name
- NCT03890744
- Testing
- ModraDoc006/r
- Where
- 4 sites in Belgium, Denmark and 1 more
- Volunteers
- 12 people
- Sponsor
- Modra Pharmaceuticals
Breast Cancer
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer.
- Trial name
- NCT00121836
- Testing
- Capecitabine, Bevacizumab
- Where
- 57 sites in United States
- Volunteers
- 109 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Non-small Lung Cancer
A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel.
- Trial name
- NCT01862081
- Testing
- Docetaxel, GDC-0032, Paclitaxel
- Where
- 14 sites in United States, Belgium and 2 more
- Volunteers
- 80 people
- Sponsor
- Genentech, Inc.
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
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
Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan
This is a retrospective, multicenter, observational study in Japan by medical record review of advanced breast cancer (ABC) patients who have received palbociclib plus endocrine therapy (ET) as first line or second line setting.
- Trial name
- NCT05399329
- Testing
- Palbociclib, Endocrine therapy
- Where
- 20 sites in Japan
- Volunteers
- 693 people
- Sponsor
- Pfizer
Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer
Study of PF-07248144 in Advanced or Metastatic Solid Tumors
This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination…
- Conditions
- Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Trial name
- KAT6 (NCT04606446)
- Testing
- PF-07248144, Fulvestrant, Letrozole
- Where
- 43 sites in United States, Australia and 3 more
- Volunteers
- 320 people
- Sponsor
- Pfizer
Breast Cancer
A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease
This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel…
- Trial name
- NCT00679341
- Testing
- Trastuzumab emtansine [Kadcyla], Trastuzumab, Docetaxel
- Volunteers
- 137 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
The purpose of study is to determine tolerability and safety profile of H3B-6545 in Japanese women with ER-positive, HER2-negative breast cancer, and also to confirm the dose applicability to Japanese.
- Trial name
- NCT04568902
- Testing
- H3B-6545, Antihistamine
- Where
- 2 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Eisai Co., Ltd.
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
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 Cancer
Dose Escalation Study of HBI-8000 in Combination With Paclitaxel and Trastuzumab in Women With Advanced or Metastatic HER2+ Breast Cancer
This is a phase I multi-center dose escalation study of the histone deacetylase inhibitor (HDACi) HBI-8000 when given in combination with paclitaxel and trastuzumab in women with advanced or metastatic HER2+ breast cancer.
- Trial name
- NCT02569489
- Testing
- HBI-8000, Trastuzumab, Paclitaxel
- Sponsor
- HUYABIO International, LLC.
Advanced Breast Cancer
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a…
- Trial name
- SERENA-1b (NCT07427394)
- Testing
- Camizestrant, Atirmociclib
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 24 people
- Sponsor
- AstraZeneca