Clinical trials: Early-Stage Breast Cancer
Breast Cancer
A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by…
- Trial name
- IMpassion050 (NCT03726879)
- Testing
- Atezolizumab, Doxorubicin, Cyclophosphamide
- Where
- 76 sites in United States, Brazil and 10 more
- Volunteers
- 454 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Colon Cancer
EXoPERT EMERALD Clinical Study
The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software.
- Conditions
- Breast Cancer, Colon Cancer, Pancreatic Cancer, Ovarian Cancer
- Trial name
- NCT07186296
- Testing
- EXoPred
- Where
- 9 sites in United States
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- EXoPERT
Breast Cancer, Breast Neoplasms
A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer
- Trial name
- NCT05346224
- Testing
- HLX11, EU-Perjeta®
- Where
- 79 sites in China, Hungary and 2 more
- Volunteers
- 900 people
- Sponsor
- Shanghai Henlius Biotech
Triple Negative Breast Cancer
A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants…
- Trial name
- NCT04613674
- Testing
- Camrelizumab Plus Chemotherapy
- Where
- China
- Volunteers
- 441 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer
The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin plus cyclophosphamide in patients with early…
- Trial name
- NCT00455533
- Testing
- Ixabepilone, Paclitaxel, Cyclophosphamide
- Where
- 49 sites in United States, Argentina and 13 more
- Volunteers
- 384 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants
This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth…
- Trial name
- HOMERUS (NCT02040935)
- Testing
- Trastuzumab
- Where
- 17 sites in Netherlands
- Volunteers
- 128 people
- Sponsor
- Hoffmann-La Roche
HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer
Safety and Pharmacokinetics of Atezolizumab Combination Treatments in Participants With HER2-Positive and HER2-Negative Breast Cancer
This is a Phase Ib, open-label, two-stage study with two active regimens in each stage designed to evaluate the safety and tolerability of combination treatment with atezolizumab, trastuzumab, and pertuzumab (with and without…
- Conditions
- HER2-Positive Metastatic Breast Cancer, HER2-Negative Metastatic Breast Cancer, Locally Advanced or Early Breast Cancer
- Trial name
- NCT02605915
- Testing
- Atezolizumab, Carboplatin, Docetaxel
- Where
- 20 sites in United States
- Volunteers
- 98 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer
RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. PURPOSE: Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of…
- Trial name
- NCT00036998
- Testing
- conventional surgery, neoadjuvant therapy, thermal ablation therapy
- Where
- 8 sites in United States, United Kingdom
- Sponsor
- Imunon
Breast Cancer
Decision Impact Study of PreciseDx Breast
The investigator's developed a digital LDT to predict invasive breast cancer (IBC) recurrence within 6 years by combining histologic features extracted from an H\&E image of the patients IBC with clinical data including the…
- Trial name
- PDxBRUTILITY (NCT06309615)
- Testing
- Standard of Care
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Precise Dx, Inc.
Advanced Breast Cancer, Early Breast Cancer
A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.
- Trial name
- NCT07310420
- Testing
- ZOLADEX
- Where
- 26 sites in United States
- Volunteers
- 176 people
- Sponsor
- TerSera Therapeutics LLC
HER2 Positive Early or Locally Advanced Breast Cancer
A Study to Compare the Effect of SB3 and Herceptin® in Women With HER2 Positive Breast Cancer
A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB3 (proposed trastuzumab biosimilar) and Herceptin® in Women with Newly…
- Trial name
- NCT02149524
- Testing
- Herceptin (trastuzuamb), SB3 (proposed trastuzumab biosimilar)
- Where
- Czechia
- Volunteers
- 875 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Metastatic Breast Cancer
An Early Phase Study of Abraxane Combined With Phenelzine Sulfate in Patients With Metastatic or Advanced Breast Cancer
This phase 1b study will determine the safety and efficacy of combined treatment of Abraxane and phenelzine sulfate (Nardil) for metastatic or locally advanced breast cancer.
- Trial name
- Epi-PRIMED (NCT03505528)
- Testing
- Nanoparticle albumin-bound paclitaxel, Phenelzine Sulfate
- Where
- 3 sites in Australia
- Volunteers
- 8 people
- Sponsor
- EpiAxis Therapeutics
HER2 Positive Breast Cancer
A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients
In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.
- Trial name
- TROIKA (NCT03013504)
- Testing
- HD201, Herceptin, Docetaxel
- Where
- 15 sites in Belarus, Bulgaria and 11 more
- Volunteers
- 503 people
- Sponsor
- Prestige Biopharma Limited
Breast Neoplasms
A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer
This study will include two groups of patients: Cohort 1 and Cohort 2. Cohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer.
- Trial name
- preEMBER (NCT07287098)
- Testing
- Imlunestrant, Goserelin, Tamoxifen 20 mg
- Where
- 87 sites in United States, Belgium and 5 more
- Volunteers
- 600 people
- Sponsor
- Eli Lilly and Company
Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Validation of the Oncoliq Test for the Early Detection of Breast Cancer.
Cancer continues to be one of the most significant public health issues worldwide. Thanks to early detection, the mortality rate of certain types of cancer has decreased significantly.
- Conditions
- Breast Cancer Detection, Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Female, Breast Cancer - Ductal Carcinoma in Situ (DCIS)
- Trial name
- NCT07331506
- Testing
- Peripheral blood draw
- Where
- Argentina
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Oncoliq US Inc
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
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
Breast Cancer
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who…
- Trial name
- AMEERA-6 (NCT05128773)
- Testing
- Amcenestrant, Tamoxifen
- Where
- 2 sites in Chile, China
- Volunteers
- 3 people
- Sponsor
- Sanofi
Breast Cancer
Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of…
- Trial name
- NCT03725059
- Testing
- Pembrolizumab (K), Paclitaxel (X), Doxorubicin (A)
- Where
- 244 sites in United States, Australia and 22 more
- Volunteers
- 1,240 people
- Sponsor
- Merck Sharp & Dohme LLC