Clinical trials: Early Breast Cancer
Breast Cancer, Metastatic, Breast Cancer Invasive
Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device
Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.
- Conditions
- Breast Cancer, Metastatic, Breast Cancer Invasive, Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- Trial name
- PROBE-CTC (NCT06807502)
- Testing
- The DM/DIV ScreenCell is the experimental product studied during this research
- Where
- France
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- ScreenCell
Breast Cancer, Early Breast Cancer
Independent, External, Blinded Retrospective Validation of an AI-based Prognostic Assay in ER-Positive/HER2-Negative Early Breast Cancer
This retrospective observational study evaluates the prognostic performance of a locked Artificial Intelligence (AI)-based assay in patients with Estrogen Receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer, Early Breast Cancer, ER-Positive HER2-Negative Breast Cancer
- Trial name
- NCT07541703
- Testing
- Locked AI-based prognostic assay
- Where
- Austria
- Volunteers
- 2,200 people
- Sponsor
- Spotlight Medical
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Breast Cancer, Liquid Biopsy, Early Detection
Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening
Breast cancer is the most common cancer that spreads beyond the initial layer of tissue it developed in, and grows into surrounding healthy tissue in women worldwide. It is associated with significant illness and death.
- Trial name
- NCT07219277
- Where
- 4 sites in United States, Canada and 1 more
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Syantra Inc.
Breast Cancer Female, Breast Cancer
Robotic vs. Open NSM for Early Stage Breast Cancer
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease
- Trial name
- SP NSM (NCT05720039)
- Testing
- Robotic NSM, Open NSM
- Where
- 15 sites in United States
- Volunteers
- 204 people
- Sponsor
- Intuitive Surgical
HER2-positive Early Breast Cancer
A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer
This study will evaluate the pharmacokinetics, efficacy, and safety of the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) as compared with those of the pertuzumab intravenous (IV)…
- Trial name
- NCT04024462
- Testing
- Pertuzumab IV, Trastuzumab IV, Pertuzumab and Trastuzumab FDC SC
- Where
- 18 sites in China
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Early Triple Negative Breast Cancer
A Clinical Study of Boserolimab (MK-5890) With Pembrolizumab and Chemotherapy in People With Early Triple-Negative Breast Cancer (MK-5890-003)
Researchers want to learn if giving boserolimab (MK-5890) with standard treatment (pembrolizumab and chemotherapy) before surgery can help treat triple negative breast cancer (TNBC).
- Trial name
- NCT06829199
- Testing
- Pembrolizumab, Paclitaxel, Carboplatin
- Where
- 2 sites in United States, Taiwan
- Sponsor
- Merck Sharp & Dohme LLC
Early Breast Cancer, Locally Advanced Breast Cancer
A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home…
- Conditions
- Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer
- Trial name
- ProHer (NCT05415215)
- Testing
- Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC), Pertuzumab IV, Trastuzumab IV
- Where
- 45 sites in Argentina, Bosnia and Herzegovina and 15 more
- Volunteers
- 346 people
- Sponsor
- Hoffmann-La Roche
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
Early Breast Cancer, Skin Condition
An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients With Early Breast Cancer Treated With Adjuvant Endocrine Therapy - BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological Adverse Events)
The goal of this European observational study (Frane, Spain, italy, Spain and Greece) is to describe the quality of life related to dermatological toxicities, in adult women patients with Early Breast Cancer (EBC), treated with…
- Conditions
- Early Breast Cancer, Skin Condition, Quality of Life
- Trial name
- BCARE (NCT06690489)
- Where
- 9 sites in France, Greece and 2 more
- Volunteers
- 155 people
- Sponsor
- Pierre Fabre Medicament
Early Breast Cancer
Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.
The purpose of this research study is to compare the efficacy and safety of EG1206A with Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant treatment for 18 weeks, followed by surgery and subsequent EG1206A…
- Trial name
- EGC102 (NCT06884254)
- Testing
- EG1206A, Perjeta
- Where
- United States
- Sponsor
- EirGenix, Inc.
Breast Cancer, Early Detection of Cancer
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.
- Trial name
- NCT04688086
- Testing
- Thermalytix
- Where
- India
- Volunteers
- 687 people, healthy volunteers welcome
- Sponsor
- Niramai Health Analytix Private Limited
Untreated Early-stage or Locally Advanced Breast Cancer
Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients
The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally…
- Trial name
- NCT06592625
- Testing
- SHR-A1811, Adebrelimab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.
- Trial name
- NCT04842617
- Testing
- SHR6390
- Where
- China
- Volunteers
- 5,274 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Early Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC)…
- Trial name
- FeDeriCa (NCT03493854)
- Testing
- Cyclophosphamide, Doxorubicin, Docetaxel
- Where
- 107 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Cancer, Breast, Triple Negative Breast Cancer
VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study
Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis.
- Conditions
- Cancer, Breast, Triple Negative Breast Cancer, Early-stage Breast Cancer
- Trial name
- NCT06409221
- Testing
- Non-interventional study, Observational only
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Concr
HER2-Positive Early Breast Cancer
A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer
This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical…
- Trial name
- PHranceSCa (NCT03674112)
- Testing
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC), Pertuzumab IV, Trastuzumab IV
- Where
- 40 sites in United States, Argentina and 15 more
- Volunteers
- 160 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Early Breast Cancer
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel…
- Trial name
- NCT03989037
- Testing
- SIBP-01, Herceptin, Docetaxel
- Where
- China
- Volunteers
- 580 people
- Sponsor
- Shanghai Institute Of Biological Products
Early Breast Cancer
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus…
- Trial name
- NCT04436744
- Testing
- Giredestrant, Anastrozole, Palbociclib
- Where
- 65 sites in United States, Australia and 9 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer, Early-stage Breast Cancer
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and…
- Conditions
- HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer, Breast Neoplasms
- Trial name
- NCT04109391
- Testing
- TX05 (trastuzumab), Herceptin (trastuzumab)
- Where
- 86 sites in Belarus, Chile and 8 more
- Volunteers
- 338 people
- Sponsor
- Tanvex BioPharma USA, Inc.