Clinical Trials for Breast Cancer

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced, unresectable or metastatic solid tumors, generally after standard therapy, receive DB-1310, a HER3-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, alone or with trastuzumab or osimertinib in selected cohorts. Expansion cohorts include molecularly defined lung, breast, prostate, head and neck, esophageal, and biliary tract cancers; selected osimertinib combination cohorts enroll previously untreated EGFR-mutated NSCLC.

ClinicalTrials.gov ID: NCT05785741

An Open-label, Phase 1, Multicenter Study to Evaluate the Safety and Preliminary Anti-tumor Activity of NT-175 in Human Leukocyte Antigen-A*02:01-Positive Adult Subjects With Unresectable, Advanced and/or Metastatic Solid Tumors That Are Positive for the TP53 R175H Mutation

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with HLA-A*02:01-positive, TP53 R175H-mutant unresectable advanced or metastatic solid tumors who have received at least one approved systemic regimen and have no curative option receive lymphodepleting chemotherapy followed by a single NT-175 infusion and interleukin-2. NT-175 is an autologous T-cell therapy engineered with a T-cell receptor targeting HLA-A*02:01-presented TP53 R175H and edited to reduce TGF-β-mediated suppression.

ClinicalTrials.gov ID: NCT05877599

A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with previously treated, locally advanced or metastatic, HER2 IHC 3+ solid tumors (excluding biliary tract cancers) who have progressed after at least one prior systemic therapy and lack standard treatment options; patients receive zanidatamab, a bispecific antibody targeting two HER2 epitopes. Eligible patients must have measurable disease, ECOG 0–1, and no active CNS metastases.

ClinicalTrials.gov ID: NCT06695845

A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With Advanced or Metastatic Solid Tumors.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Adults with advanced or metastatic ER-positive/HER2-negative breast cancer after endocrine therapy and a CDK4/6 inhibitor are the main population; monotherapy dose escalation also includes castration-resistant prostate cancer and non-small cell lung cancer. The study tests oral PF-07248144, a KAT6A/KAT6B histone acetyltransferase inhibitor, alone or with fulvestrant, letrozole plus palbociclib, or fulvestrant plus the selective CDK4 inhibitor atirmociclib.

ClinicalTrials.gov ID: NCT04606446

A Pragmatic Phase II Trial of SOC Chemotherapy +/- Tocilizumab for Metastatic Triple Negative and ER-low Breast Cancers

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Eligible adults with locally recurrent, unresectable or metastatic triple negative or ER-low breast cancer (≤9% ER, ECOG 0-1, ≤1 prior metastatic chemo) are randomized to receive standard of care chemotherapy with or without tocilizumab, an anti-IL-6 receptor monoclonal antibody, with cohorts stratified by race. Prior immune checkpoint inhibitor therapy is allowed, but patients with active CNS disease, known HER2+ tumors, or prior tocilizumab are excluded.

ClinicalTrials.gov ID: NCT05846789

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Patients with advanced solid tumors are enrolled in biomarker- and tumor-specific cohorts, including homologous-recombination-repair–mutated breast, ovarian, pancreatic or castration-resistant prostate cancer; recurrent IDH-mutant glioma; HER2-expressing or HER2-mutant tumors; and previously treated triple-negative breast, endometrial, ovarian or prostate cancer. They receive the brain-penetrant, PARP1-selective inhibitor palacaparib (AZD9574) alone or with temozolomide, the HER2-directed antibody–drug conjugate trastuzumab deruxtecan, or the TROP2-directed antibody–drug conjugate datopotamab deruxtecan.

ClinicalTrials.gov ID: NCT05417594

A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with HER2-negative metastatic breast cancer and measurable brain metastases (ECOG 0-1, ≤3 prior chemo regimens) to receive utidelone, a microtubule-stabilizing epothilone analog, alone or with capecitabine. Key exclusions include prior capecitabine failure, leptomeningeal disease, or lesions needing urgent intervention.

ClinicalTrials.gov ID: NCT06764940

Safety and Efficacy of Brodalumab in the Treatment of Immune-Related Adverse Events: A Pilot Study

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with advanced or metastatic solid tumors who developed IL-17–mediated immune-related adverse events after immunotherapy and require systemic steroids, testing brodalumab (an IL-17 receptor A inhibitor) as a potential steroid-sparing treatment for irAEs. Patients receive subcutaneous brodalumab alongside a planned steroid taper.

ClinicalTrials.gov ID: NCT06673329

Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with metastatic or locally advanced, inoperable triple negative breast cancer who have at least one lesion suitable for cryoablation and are eligible for pembrolizumab, a PD-1 inhibitor. It compares pembrolizumab alone to pembrolizumab combined with cryoablation to assess whether the addition of local ablation enhances immune response.

ClinicalTrials.gov ID: NCT06246968

A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

TrialFetch AI summary: Patients aged 12 years or older with metastatic or unresectable solid tumors, including breast cancer and NUT carcinoma, may enter dose escalation if standard options are unavailable or ineffective; expansion is limited to measurable, laboratory-confirmed NUT carcinoma. Treatment combines oral ZEN003694, an investigational BET protein inhibitor, with oral abemaciclib, a CDK4/6 inhibitor.

ClinicalTrials.gov ID: NCT05372640