Triple Negative Breast Neoplasms

17

Review clinical trials related to Triple Negative Breast Neoplasms. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Participants needed: 2,400
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Merck Sharp & Dohme LLCUpdated: Jul 2, 2026Locations: 310
Eligibility criteria

cT1c, N1-N2 [+7]

Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involve... [+10]

Status: Recruiting

A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Participants needed: 1,109
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Bristol-Myers SquibbUpdated: Jun 30, 2026Locations: 47
Eligibility criteria

Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker... [+5]

Women who are pregnant or breastfeeding. [+11]

Status: Recruiting

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Participants needed: 1,000
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Merck Sharp & Dohme LLCUpdated: Jun 29, 2026Locations: 263
Eligibility criteria

Has locally recurrent unresectable or metastatic TNBC that cannot be treated wit... [+6]

Has breast cancer amenable to treatment with curative intent [+16]

Status: Recruiting

A Study of LY4170156 in Participants With Selected Advanced Solid Tumors

The purpose of this study is to find out whether the study drug, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Participants needed: 495
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Eli Lilly and CompanyUpdated: Jun 18, 2026Locations: 23
Eligibility criteria

Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian... [+2]

Individual with known or suspected uncontrolled central nervous system (CNS) met... [+8]

Status: Not yet recruiting

A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.

This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors who are refractory to, intolerant of, or ineligible for standard of care.

Participants needed: 227
Trial details
Phase: Phase 2Age: 18-80Biological sex: AllType: InterventionalSponsor: GV20 TherapeuticsUpdated: Jun 8, 2026Locations: 2
Eligibility criteria

Voluntarily signed written informed consent (ICF) prior to any study-specific pr... [+17]

Prior immunotherapy discontinued due to ≥ Grade 3 immune-related adverse events... [+24]

Status: Recruiting

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.

Participants needed: 30
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: May 20, 2026Locations: 7
Eligibility criteria

Patients ≥ 18 years of age [+21]

Patient not eligible for PD-1 inhibitor per the patient's medical oncologist [+2]

Status: Recruiting

A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer

This clinical trial is looking at UCB4594. This is the first time the drug is being tested in humans. UCB4594 is a type of drug called a monoclonal antibody. It has been designed to work by targeting a protein called human leucocyte antigen G (HLA-G) that is found in high levels on some cancer cells. By attaching itself to this protein it may help the immune system to attack and kill the cancer cells. The four main aims of the clinical trial are to find out: 1. The best dose of UCB4594 that can be given safely to participants in the trial. 2. What the side effects of UCB4594 are and how they can be managed. 3. What happens to UCB4594 inside the body and how it affects cancer cells. 4. Whether UCB4594 can cause cancer to shrink.

Participants needed: 167
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Cancer Research UKUpdated: May 8, 2026Locations: 4
Eligibility criteria

Written (signed and dated) informed consent and capable of co-operating with inv... [+6]

Radiotherapy (except palliative), endocrine therapy (unless for non-malignant di... [+19]

Status: Recruiting

A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors

This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.

Participants needed: 714
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Seagen, a wholly owned subsidiary of PfizerUpdated: Apr 20, 2026Locations: 61
Eligibility criteria

Participants must have one of the following histologically- or cytologically-con... [+24]

History of another malignancy within 3 years of first dose of study treatment or... [+7]

Status: Recruiting

A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors

The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).

Participants needed: 150
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: NiKang Therapeutics, Inc.Updated: Apr 21, 2026Locations: 19
Eligibility criteria

Ovarian cancer [+10]

Locally advanced solid tumor that is a candidate for curative treatment through... [+13]

Status: Recruiting

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.

Participants needed: 53
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: Universitaire Ziekenhuizen KU LeuvenUpdated: Apr 1, 2026Locations: 6
Eligibility criteria

Provision of signed and dated, written informed consent prior to any study speci... [+16]

Major surgery (excluding placement of vascular access) within 4 weeks of the fir... [+33]

Status: Recruiting

Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery

The goal of this clinical trial is to evaluate the efficacity and safety of pembrolizumab and capecitabine on the invasive disease-free survival, in participants who have triple negative breast cancer (TNBC) with residual disease after neoadjuvant chemotherapy associated with pembrolizumab.

Participants needed: 220
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: UNICANCERUpdated: Nov 17, 2025Locations: 20
Eligibility criteria

Patient must have signed a written informed consent prior to any trial specific... [+40]

Radiological or clinical evidence of metastatic disease documented by imaging or... [+3]

Status: Not yet recruiting

A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC

This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1 positive. Eligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter. The primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.

Participants needed: 150
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUpdated: Sep 8, 2025Locations: 1
Eligibility criteria

Female patients aged ≥18 years. [+8]

Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies. [+6]

Status: Not yet recruiting

Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer

This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer. The goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?

Participants needed: 260
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: UNICANCERUpdated: Sep 3, 2025Locations: 2
Eligibility criteria

Patient must have signed a written informed consent prior to any trial specific... [+8]

Patient previously treated with any ADC targeting HER2 or TROP2 [+11]

Status: Recruiting

Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

This is a Phase II, single-arm, open label study to evaluate Olaparib plus Pembrolizumab following platinum-based chemotherapy plus Pembrolizumab as neoadjuvant therapy for germline BRCA (gBRCA) 1/2 mutated triple negative breast cancer (TNBC). Pembrolizumab in combination with weekly paclitaxel and carboplatin (treatment 1) is followed by Pembrolizumab in combination with Olaparib (treatment 2) in neoadjuvant setting and Pembrolizumab in combination with Olaparib in adjuvant setting will be studied

Participants needed: 23
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Okayama UniversityUpdated: Mar 20, 2025Locations: 3
Eligibility criteria

Male/female subjects who are at least 18 years of age on the day of signing info... [+10]

Subjects who has a positive urine pregnancy test within 72 hours prior to regist... [+27]

Status: Recruiting

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 surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.

Participants needed: 185
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Baylor Breast Care CenterUpdated: Feb 27, 2025Locations: 2
Eligibility criteria

At least 18 years of age, and legally able to provide informed consent. Both men... [+14]

Definitive clinical or radiologic evidence of Stage IV disease [+18]

Status: Recruiting

Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy

This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug. Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.

Participants needed: 53
Trial details
Phase: Phase 2Age: 18-70Biological sex: FemaleType: InterventionalSponsor: Hunan Cancer HospitalUpdated: Apr 26, 2024Locations: 1
Eligibility criteria

Signed informed consent; [+9]

Metastatic breast cancer at diagnosis; [+14]

Status: Not yet recruiting

Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study

CAREGIVER is a prospective, randomized, multicenter, open, five-arm study with unequal allocation ratios of 1:1:2:1:2 (palbociclib : paclitaxel : palbociclib + paclitaxel : carboplatin : carboplatin + paclitaxel). Study will be performed in untreated patients with triple-negative breast cancer (TNBC). Potential candidates without previously established diagnosis of TNBC will be included in a Pre-screening Phase, when a biopsy of breast tumor will be taken to confirm the diagnosis of cancer, select patients with TNBC and collect tissue for translational research.

Participants needed: 126
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Medical University of GdanskUpdated: Oct 5, 2021Locations: 6
Eligibility criteria

females or males >18 years old at the time of informed consent signature; [+24]

inflammatory breast cancer; [+16]