Clinical Trials for Breast Cancer

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected Advanced 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.

HealthScout AI summary: This trial investigates GSK4381562, a monoclonal antibody targeting PVRIG to enhance NK and T cell activation, as monotherapy and in combination with anticancer agents such as dostarlimab, belrestotug, nelistotug, and GSK5764227 in patients with advanced solid tumors who lack standard treatment options. Eligible participants have locally recurrent or metastatic solid tumors, have progressed after standard therapies, and possess an ECOG performance status of 0-1 with adequate organ function.

ClinicalTrials.gov ID: NCT05277051

IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 β/γ Alone or in Combination With Pembrolizumab, TransCon TLR7/8 Agonist, or Other Anticancer Therapies, in Adult Participants With Locally Advanced or Metastatic Solid Tumor Malignancies

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.

HealthScout AI summary: This trial targets adult patients with locally advanced or metastatic solid tumor malignancies, evaluating the safety and tolerability of TransCon IL-2 β/γ, a long-acting IL-2Rβ/γ receptor-targeting prodrug, alone or in combination with pembrolizumab, TransCon TLR7/8 agonist, or other anticancer therapies.

ClinicalTrials.gov ID: NCT05081609

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression

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.

HealthScout AI summary: This trial involves patients over 18 with advanced solid tumors expressing high levels of EphA2, testing the safety and efficacy of BT5528, a targeted Bicycle Toxin Conjugate linked to MMAE, as a monotherapy and in combination with the PD-1 inhibitor nivolumab, particularly in ovarian, urothelial, lung, breast, head and neck, and gastric cancers after progression on standard treatments.

ClinicalTrials.gov ID: NCT04180371

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

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.

HealthScout AI summary: This trial targets adults with breast cancer or NSCLC with leptomeningeal metastases, using craniospinal irradiation with hippocampal avoidance via proton or VMAT to reduce neurological side effects while effectively treating the cancer. Participants require a KPS of ≥ 60 and suitable blood counts, and treatment is given over two weeks.

ClinicalTrials.gov ID: NCT06518057

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)

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.

HealthScout AI summary: This trial compares proton craniospinal irradiation (pCSI) versus involved-field radiotherapy (IFRT) in adult patients with leptomeningeal metastasis from breast cancer or non-small cell lung cancer, focusing on overall survival and other CNS outcomes.

ClinicalTrials.gov ID: NCT06500481

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)

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.

HealthScout AI summary: This trial enrolls adults with metastatic HER2-positive breast cancer who have progressed after taxane, trastuzumab, and trastuzumab deruxtecan (T-DXd), including those with stable, treated brain metastases, to receive sacituzumab govitecan (a Trop-2-directed antibody-drug conjugate delivering SN-38) in combination with trastuzumab. Prior treatment with a Trop-2-directed ADC is not allowed.

ClinicalTrials.gov ID: NCT06100874

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination with Eribulin and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ 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.

HealthScout AI summary: This trial enrolls adults with unresectable or metastatic HER2-positive breast cancer who have progressed after or were intolerant to trastuzumab, a taxane, and trastuzumab deruxtecan, including those with controlled brain metastases and prior tucatinib exposure. Patients receive tucatinib (a selective HER2 tyrosine kinase inhibitor), eribulin (a microtubule inhibitor), and trastuzumab.

ClinicalTrials.gov ID: NCT05458674

A Phase 1/2 Study of [225Ac]-FPI-1434 Injection in Patients With Locally Advanced or Metastatic Solid Tumours

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.

HealthScout AI summary: Eligible patients are adults with advanced, metastatic, or recurrent solid tumors (including endometrial, cervical, ovarian, triple-negative or HER2-negative breast, head and neck, adrenocortical, or uveal melanoma) that express IGF-1R and lack standard treatment options. Treatment involves [225Ac]-FPI-1434, a humanized anti-IGF-1R monoclonal antibody conjugated to the alpha-emitter actinium-225 for targeted alpha radioimmunotherapy, with optional use of unlabeled antibody (FPI-1175) to optimize safety and efficacy.

ClinicalTrials.gov ID: NCT03746431

An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, and Pharmacokinetics of BTX A51 Alone and in Combination With Fulvestrant in Subjects With Advanced Solid Tumors and Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer

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.

HealthScout AI summary: This trial enrolls adults with advanced solid tumors or ER-positive, HER2-negative metastatic breast cancer who are refractory to standard therapy, evaluating the novel oral multi-kinase inhibitor BTX-A51 (targeting CK1α, CDK7, and CDK9) alone or with fulvestrant. Patients must have adequate organ function and no significant comorbidities.

ClinicalTrials.gov ID: NCT04872166

A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

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.

HealthScout AI summary: This trial enrolls adults with relapsed or metastatic solid tumors—particularly breast, ovarian, endometrial, biliary tract, and squamous NSCLC—who have received prior therapy, evaluating the antibody-drug conjugate AZD8205 (targets B7-H4 and delivers a topoisomerase I inhibitor) as monotherapy or in combination with the PD-1/TIGIT bispecific antibody rilvegostomig or the PARP inhibitor saruparib. Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function, with some sub-studies focusing on select tumor types.

ClinicalTrials.gov ID: NCT05123482