Clinical trials: HER2-Negative Breast Cancer
HER2-positive Breast Cancer, ER-Negative Breast Cancer
De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade
DECRESCENDO is a multicentre, open-label, dual-phase single-arm phase II de-escalation study evaluating neoadjuvant treatment with 12 administrations of weekly IV paclitaxel 80 mg/m2 (or IV docetaxel 75 mg/m2 every 3 weeks for 4…
- Conditions
- HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer, Node-negative Breast Cancer
- Trial name
- Decrescendo (NCT04675827)
- Testing
- Pertuzumab and tratuzumab fixed dose combination, Trastuzumab emtansine
- Where
- 85 sites in Australia, Belgium and 4 more
- Volunteers
- 139 people
- Sponsor
- Jules Bordet Institute
Breast Cancer
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with…
- Trial name
- NCT06112379
- Testing
- Dato-DXd, Durvalumab, Pembrolizumab
- Where
- 283 sites in United States, Australia and 24 more
- Volunteers
- 1,902 people
- Sponsor
- AstraZeneca
Primary Breast Cancer
Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)
Cabazitaxel is a new taxoid which promotes the tubulin assembly in vitro and stabilizes microtubules against cold-induced depolymerization as efficiently as docetaxel and was selected for development based on a better…
- Trial name
- NCT01779479
- Testing
- Cabacitaxel, Paclitaxel
- Where
- Germany
- Volunteers
- 333 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer
PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative…
- Trial name
- NCT01074970
- Testing
- Cisplatin, Rucaparib
- Where
- 27 sites in United States
- Volunteers
- 135 people
- Sponsor
- Hoosier Cancer Research Network
Breast Cancer Metastatic
Efficacy and Safety of Biweekly Regimen of Eribulin Versus a Standard Regimen for the Treatment of Locally Recurrent or Metastatic HER2-negative Breast Cancer: a Multicenter, Randomized, Open-label, Phase III Trial
Eribulin is a soft spongin-like inhibitor of mitotic microtubule dynamics in cells. From the evidence of efficacy, the STUDY 305 and STUDY 301 studies suggest that eribulin improves PFS and OS in patients with breast cancer.
- Trial name
- NCT06857305
- Testing
- Eribulin biweekly regimen, Eribulin standard regimen
- Where
- China
- Volunteers
- 192 people
- Sponsor
- Ma Fei，MD
Breast Neoplasm
SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.
- Trial name
- STEM (NCT02970682)
- Testing
- SFX-01, Fulvestrant, Tamoxifen
- Where
- 10 sites in Belgium, France and 2 more
- Volunteers
- 60 people
- Sponsor
- Evgen Pharma
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
Patients who have histologically confirmed metastatic or unresectable (not amenable to curative therapy) breast cancer may be screened for eligibility.
- Conditions
- Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer, PIK3CA Mutant Metastatic Breast Cancer
- Trial name
- NCT04762979
- Testing
- Alpelisib, Fulvestrant, Aromatase inhibitor
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Marina N Sharifi
Breast Cancer
A Phase 1b/2 Trial Evaluating Safety and Efficacy of CAPecitabine in Combination With Ni-rapaRIb in HER2-negative Advanced Breast canCEr
This study will be to combine oral capecitabine and oral niraparib such thz association may increase clinical benefits of PARP inhibitors in germline BRCA mutated HER2 negative advanced breast cancer patients.
- Trial name
- CAPRICE (NCT05519670)
- Testing
- Niraparib Oral Product
- Volunteers
- 72 people
- Sponsor
- Institut Paoli-Calmettes
Breast Cancer
A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients
This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.).
- Trial name
- NCT05266105
- Testing
- Palazestrant, Palbociclib
- Where
- 8 sites in Australia
- Volunteers
- 60 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Estrogen Receptor Positive, HER2/Neu Negative
RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer
This partially randomized phase I trial is studying the side effects and the best dose of RO4929097 when given together with exemestane and to see how well it works compared to exemestane alone in treating premenopausal and…
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Recurrent Breast Carcinoma
- Trial name
- NCT01149356
- Testing
- Exemestane, Gamma-Secretase Inhibitor RO4929097, Goserelin Acetate
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
- Trial name
- NCT06081959
- Testing
- SKB264, Eribulin, Capecitabine
- Where
- China
- Volunteers
- 376 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Triple Negative Breast Neoplasms
Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab
Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients.
- Trial name
- A-Brave (NCT02926196)
- Testing
- MSB0010718C
- Where
- 70 sites in Italy, United Kingdom
- Volunteers
- 474 people
- Sponsor
- Istituto Oncologico Veneto IRCCS
Breast Cancer
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer.
- Trial name
- TACTIVE-E (NCT05501769)
- Testing
- ARV-471 in combination with Everolimus
- Where
- 9 sites in United States, Spain
- Volunteers
- 32 people
- Sponsor
- Arvinas Estrogen Receptor, Inc.
Metastatic Breast Cancer
Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer
This randomized, double blind, placebo controlled trial will evaluate the impact of adding everolimus to the combination of weekly paclitaxel plus bevacizumab in the first-line treatment of women with HER2-negative metastatic…
- Trial name
- NCT00915603
- Testing
- Everolimus, Bevacizumab, Paclitaxel
- Where
- 15 sites in United States
- Volunteers
- 113 people
- Sponsor
- SCRI Development Innovations, LLC
Advanced Cancer, Metastatic Cancer
A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors
This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to: Find the recommended dose of ART4215 that can be given safely to participants…
- Conditions
- Advanced Cancer, Metastatic Cancer, Breast Cancer
- Trial name
- NCT04991480
- Testing
- ART4215, Talazoparib, Niraparib
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 93 people
- Sponsor
- Artios Pharma Ltd
Breast Cancer
Ph II Study of Pembrolizumab & Eribulin in Patients With HR+/HER2- MBC Previously Treated With Anthracyclines & Taxanes
This a multicenter, open-label, phase II clinical trial to assess the efficacy of pembrolizumab in combination with eribulin in female patients older than 18 years old with hormone receptor-(HR)positive/HER2-negative metastatic…
- Trial name
- KELLY (NCT03222856)
- Testing
- Pembrolizumab, Eribulin
- Where
- 11 sites in Spain
- Volunteers
- 44 people
- Sponsor
- MedSIR
HER-2 Positive Breast Cancer
Characteristics of Disseminated Her2+ Breast Cancer Patients Treated With Trastuzumab That Have Reached Complete, Partial Remission or Stabilization of Disease During More Than 3 Years
Main objective: To analyze the clinical and biological characteristics of patients with disseminated breast cancer HER2 + treated with trastuzumab that have achieved a complete remission, partial or stable disease for a period…
- Trial name
- LongHer (NCT01433926)
- Where
- 39 sites in Spain
- Volunteers
- 114 people
- Sponsor
- Asociación para el Progreso de la Oncología en Málaga
Breast Cancer - Infiltrating Ductal Carcinoma, HER-2 Positive Breast Cancer
Concurrent Neoadjuvant Chemo/Endocrine Therapy in HER2+ Breast Cancer
The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery.
- Trial name
- NCT07506876
- Testing
- Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Legacy Health System
Breast Cancer, Cancer of the Breast
NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer
This study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection. It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage II/III ER-positive…
- Trial name
- NCT05837455
- Testing
- VENTANA MIB-1 Ki67 assay, Oncotype DX® Recurrence Score, PAM50-based Prosigna breast cancer gene signature assay
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer
This is an international, multi-center, randomized, double-blinded, placebo-controlled clinical study evaluating the efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone…
- Trial name
- EarLEE-2 (NCT03081234)
- Testing
- Ribociclib, Adjuvant endocrine therapy
- Sponsor
- Novartis Pharmaceuticals