Clinical trials: Early Triple-Negative Breast Cancer, open to volunteers
Triple Negative Breast Cancer, Breast Cancer
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from…
- Trial name
- NCT04768426
- Testing
- Capecitabine
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University
TNBC - Triple-Negative Breast Cancer, TNBC
Phase II Trial of Pembrolizumab/Chemotherapy With Live Biotherapeutic Product MO-03 in Patients With Early Stage Triple Negative Breast Cancer
This is a single-arm and single site phase II trial combination of chemotherapy and pembrolizumab with LBP MO-03 in 50 trial participants with early triple negative breast cancer.
- Conditions
- TNBC - Triple-Negative Breast Cancer, TNBC, Early Stage Triple-Negative Breast Carcinoma
- Trial name
- NCT07552181
- Testing
- Live biotherapeutic product: MO-03 1 capsule PO BID
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yuan Yuan
Breast Cancer, Triple-negative Breast Cancer
NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer
TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes.
- Trial name
- ADAPT-TN-IV (NCT07178730)
- Testing
- Sacituzumab govitecan, Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA], SoC Chemotherapy
- Where
- 26 sites in Germany
- Volunteers
- 765 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Neoplasms, Breast Cancer
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Tumors, Angiosarcoma
- Trial name
- I-SPY (NCT01042379)
- Testing
- Standard Therapy, AMG 386 with or without Trastuzumab, AMG 479 (Ganitumab) plus Metformin
- Where
- 42 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Triple-Negative Breast Cancer (TNBC)
Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer
This randomized, multicenter, open-label clinical study will evaluate whether adding the Fasten Onco digital therapy, which supports a fasting-mimicking diet (FMD), to standard neoadjuvant treatment can reduce treatment-related…
- Trial name
- FAST-01 (NCT07884721)
- Testing
- Fasten Onco, Standard Neoadjuvant Treatment
- Where
- 7 sites in France
- Volunteers
- 144 people
- Sponsor
- FASTEN
Breast Neoplasm, Breast Cancer
Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy
The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for…
- Conditions
- Breast Neoplasm, Breast Cancer, Breast Tumors, Triple-Negative Breast Cancer (TNBC)
- Trial name
- FASCINATE-N (NCT05582499)
- Testing
- Dalpiciclib, Pyrotinib, SHR-A1811
- Where
- China
- Volunteers
- 716 people
- Sponsor
- Fudan University
Breast Cancer
FMD and Neoadjuvant Chemo-immunotherapy in TNBC
The primary objective of this study is to investigate the efficacy and safety of a fasting-mimicking diet (FMD) intervention combined with standard neoadjuvant chemoimmunotherapy in early-stage or locally advanced triple-negative…
- Trial name
- FACT-TN (NCT07378306)
- Testing
- Fasting-mimicking diet, Chemotherapy, Toripalimab
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Sun Yat-sen University
TNBC - Triple-Negative Breast Cancer
Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer…
- Trial name
- NCT05914961
- Where
- Germany
- Volunteers
- 225 people
- Sponsor
- University Hospital Tuebingen
Triple Negative Breast Cancer (TNBC), Early Setting
Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
CAPTIVATE is a multi-center translational and observational trial, that aims to investigate the impact of the gut microbiome on treatment outcomes in women with untreated, stage I-III Triple Negative undergoing neoadjuvant…
- Trial name
- CAPTIVATE (NCT07551765)
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Barts & The London NHS Trust
TNBC
A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer
Camrelizumab + Chemoradiotherapy for Early TNBC Sponsor/Leading Center: Tianjin Medical University Cancer Institute and Hospital Study Type: Single-arm, single-center, Phase Ⅱ clinical study Planned Enrollment: 43 patients…
- Trial name
- NCT07491822
- Testing
- treatment group
- Volunteers
- 43 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
TNBC, Triple Negative Breast Cancer
TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer
Refining neoadjuvant chemoimmunotherapy and establishing predictive biomarkers remain pivotal challenges in early TNBC. Although SG/I (sacituzumab govitecan/PD-1 inhibitor) shows clinical promise, validation of responder…
- Trial name
- TREND-02 (NCT07271992)
- Testing
- SG+I
- Volunteers
- 30 people
- Sponsor
- First Hospital of China Medical University
TNBC, Triple Negative Breast Cancer
A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC
Triple-negative breast cancer (TNBC) accounts for about 20% of breast cancers, is poorly differentiated, progresses rapidly, and frequently recurs, making it the subtype with the worst prognosis.
- Trial name
- NCT07178171
- Testing
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4), Pirarubicin, Nab-paclitaxel
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xijing Hospital
Triple Negative Breast Cancer
Predictive Biomarkers of Response to Checkpoint Inhibitors in Triple Negative Breast Cancer: a Multiomics Platform
Patients with stage II-III Triple negative breast cancer (TNBC) candidates to receive neoadjuvant chemotherapy (NACT) +/- immune checkpoint inhibitor (ICI) will be included.
- Trial name
- PORTRAIT (NCT05916755)
- Testing
- Whole Genome Sequencing, RNA-Sequencing, Microbiome analysis
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Vall d'Hebron Institute of Oncology
TNBC - Triple-Negative Breast Cancer
SHR-A2102 Combined With Adebrelimab as Neoadjuvant Therapy for Early Triple-Negative Breast Cancer
This is a prospective, open-label, multicenter Phase II study evaluating the efficacy and safety of of SHR-A2102 in combination with Adebrelimab in Early Triple-Negative Breast Cancer(TNBC)
- Trial name
- NCT06819319
- Testing
- SHR-A2102 ; Adebrelimab injection
- Volunteers
- 52 people
- Sponsor
- Henan Cancer Hospital
Triple Negative Breast Cancer (TNBC), Elevated Tumor-Infiltrating Lymphocytes
A Phase II Study of Biomarker-Guided De-escalation Using Anthracycline-Free Neoadjuvant Chemoimmunotherapy in Early-Stage Triple Negative Breast Cancer (TNBC) Patients With High Tumor-Infiltrating Lymphocytes (TILs)
This study tests a new treatment approach for people with early-stage triple negative breast cancer whose tumors have a high number of immune cells, called tumor-infiltrating lymphocytes or TILs, as seen by a pathologist on…
- Trial name
- NeoTILs (NCT07743190)
- Testing
- Carboplatin, Paclitaxcel, Pembrolizumab
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Medical University of South Carolina
Breast Neoplasms
Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy
This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC)…
- Trial name
- NCT06313463
- Testing
- Carrellizumab + Capecitabine
- Where
- China
- Volunteers
- 375 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer, Breast Neoplasm
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when…
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Cancer Female, Breast Cancer Invasive
- Trial name
- RESPONSE (NCT05020860)
- Testing
- Paclitaxel, Carboplatin, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 185 people
- Sponsor
- Baylor Breast Care Center
Triple-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK
About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast…
- Trial name
- NCT06358573
- Testing
- INT230-6, neoadjuvant immuno-chemotherapy
- Where
- 10 sites in France, Switzerland
- Volunteers
- 61 people
- Sponsor
- Swiss Cancer Institute
Triple Negative Breast Cancer
NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)
TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour…
- Trial name
- ADAPT-TN-III (NCT06081244)
- Testing
- Sacituzumab govitecan, Pembrolizumab
- Where
- 43 sites in Germany
- Volunteers
- 348 people
- Sponsor
- Women's Cancer Study Group GmbH
TNBC, Triple Negative Breast Cancer, Early Breast Cancer
MRI-Guided Neoadjuvant Treatment De-Escalation in Stage II-III TNBC
Breast cancer is the most common malignancy among women worldwide. Triple-negative breast cancer (TNBC), defined by the lack of estrogen receptor, progesterone receptor, and HER2 expression, comprises approximately 15% of all…
- Trial name
- NOGA (NCT07327021)
- Testing
- Treatment De-Escalation and Early Surgery
- Where
- 2 sites in Israel
- Volunteers
- 54 people
- Sponsor
- Tel-Aviv Sourasky Medical Center