Clinical trials: TNBC, open to volunteers
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
Triple Negative Breast Cancer
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
Eligible patients with stage 2 and 3 triple negative breast cancer will be treated with 4 cycles of neoadjuvant paclitaxel/carboplatin/pembrolizumab. A PET scan will be performed at baseline and after 1 cycle of therapy.
- Trial name
- NeoADAPT (NCT06245889)
- Testing
- Paclitaxel, Carboplatin, Pembrolizumab
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer, Triple Negative Breast Cancer
Viscum Album for TNBC on Adjuvant Pembrolizumab
The goal of this clinical trial is to evaluate the efficacy and safety of Viscum album extract when used in combination with pembrolizumab as adjuvant chemotherapy in adult patients (aged 19 and older) who have been diagnosed…
- Trial name
- TNBNOBA (NCT06920810)
- Testing
- viscum album
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Ilsan Cha hospital
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
Breast Cancers, Triple Negative Breast Cancer (TNBC)
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study.
- Trial name
- OPT-PEMBRO (NCT06606730)
- Testing
- Pembrolizumab, Deescalation
- Where
- 2 sites in Belgium, France
- Volunteers
- 2,454 people
- Sponsor
- UNICANCER
Triple-Negative Breast Cancer (TNBC)
AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally…
- Trial name
- NCT06767527
- Testing
- AK112, Nab-paclitaxel
- Where
- China
- Volunteers
- 416 people
- Sponsor
- Akeso
Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0111 when administered intratumorally in…
- Conditions
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- Trial name
- NCT06700070
- Testing
- PBA-0111
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Pure Biologics S.A.
Breast Cancer, Triple Negative Breast Cancer (TNBC)
Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer
This is a prospective radiation dose-finding, phase 2 expansion study of the Triple Negative (TN) cohort of the multicenter randomized study P-RAD (A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2-Negative Breast Carcinoma, Node-positive Breast Cancer
- Trial name
- P-RAD(+)TN-DCT (NCT07276880)
- Testing
- Neoadjuvant Pembrolizumab, low dose neoadjuvant boost, High dose neoadjuvant boost
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Neoplasm, Triple Negative Breast Cancer (TNBC)
PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition With or Without Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Treatment Resistant Residual Triple Negative Breast Cancer
PHOENIX is a window of opportunity (WOP), open-label, multi-centre, phase IIa trial comprising multiple non-comparative treatment cohorts with patient allocation via minimisation (cohorts A-D) or allocation according to HRD and…
- Conditions
- Breast Neoplasm, Triple Negative Breast Cancer (TNBC), HRD
- Trial name
- PHOENIX (NCT03740893)
- Testing
- AZD6738, Olaparib, Durvalumab
- Where
- 6 sites in United Kingdom
- Volunteers
- 119 people
- Sponsor
- Institute of Cancer Research, United Kingdom
TNBC - Triple-Negative Breast Cancer, TNBC
A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation
This is an open-label, Simon's optimal two-stage design, single-arm, Phase II study with first 6 patients in the safety run-in portion.
- Trial name
- NCT07441512
- Testing
- Inavolisib in Combination With Eribulin
- Volunteers
- 26 people
- Sponsor
- Hu Hai
TNBC - Triple-Negative Breast Cancer, Breast Cancer
ASTRAEA: ReinvigorAting ReSponse To ImmunotheRApy in MEtAstatic TNBC With Combination Myeloid Inhibition and Radiation
Open label, single-arm, prospective therapeutic trial. Pembrolizumab (MK-3475), 200 mg IV Q3W starting at C1D1/Week 1 for up to 2 years, until disease progression, or treatment intolerance.
- Trial name
- NCT07015853
- Testing
- Pembrolizumab, Radiotherapy, Axatilimab
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Stephen Shiao
Breast Cancer, Triple Negative Breast Cancer
Use of Imatinib to Convert Triple Negative Breast Cancer Into ER-positive Breast Cancer (I-CONIC)
This is a single centre Window-of-Opportunity trial investigating the efficacy and feasibility of short term imatinib in patients with newly diagnosed triple negative breast cancer (TNBC) planned for surgery, with tumours ≥ 15…
- Trial name
- I-CONIC (NCT05722795)
- Testing
- Imatinib 400 MG Oral Tablet
- Where
- Sweden
- Volunteers
- 40 people
- Sponsor
- Vastra Gotaland Region
Breast Cancer, TNBC - Triple-Negative Breast Cancer
Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies
For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, HER2 + Breast Cancer
- Trial name
- GEMINI Breast (NCT07211178)
- Testing
- There are no interventions in this observational study.
- Where
- 16 sites in United States
- Volunteers
- 900 people
- Sponsor
- Tempus AI
Triple Negative Breast Cancer (TNBC)
Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer
This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC).
- Trial name
- VITAL-TNBC (NCT07652242)
- Testing
- ITI-5000 mRNA Vaccine, Pembrolizumab, Olaparib
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Immunomic Therapeutics, Inc.
Triple Negative Breast Cancer (TNBC), Advanced Solid Tumors Cancer
PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer
The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for…
- Trial name
- NCT07190469
- Testing
- PQ203
- Where
- 4 sites in United States, Canada
- Volunteers
- 80 people
- Sponsor
- ProteinQure Inc.
Breast Neoplasms
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group.
- Trial name
- NCT07173751
- Testing
- Pumitamig, Nab-paclitaxel/Paclitaxel, Gemcitabine
- Where
- 224 sites in United States, Argentina and 17 more
- Volunteers
- 558 people
- Sponsor
- BioNTech SE
TNBC - Triple-Negative Breast Cancer
Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07)
This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR） of treatment of TNBC breast cancer with neoadjuvant chemotherapy…
- Trial name
- NCT07351487
- Testing
- Neoadjuvant chemotherapy combined with Sintilimab and Bevacizumab
- Where
- 2 sites in China
- Volunteers
- 37 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
TNBC, Triple Negative Breast Cancer
QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC
This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r/mTNBC
- Trial name
- NCT06786026
- Testing
- bevacizumab, QL1706, Nab paclitaxel
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Fudan University
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
Triple-Negative Breast Cancer (TNBC)
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
This Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 in patients with advanced triple-negative breast cancer (TNBC) who have progressed after prior therapy.
- Trial name
- NCT07208149
- Testing
- MR001 Bispecific Antibody for Injection
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Shenzhen Majory Biotechnology Co., Ltd.