Clinical Trials for Breast Cancer

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced 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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: This trial enrolls adults with advanced HRR-mutated solid tumors—including previously treated breast, ovarian, fallopian tube, primary peritoneal, castration-resistant prostate, or pancreatic cancers—who may have had limited prior PARP inhibitor exposure and CNS metastases if stable. Patients receive EIK1004 (IMP1707), a highly selective CNS-penetrant PARP1 inhibitor, as oral monotherapy.

ClinicalTrials.gov ID: NCT06907043

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

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.

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 metastatic breast cancer (ER+/HER2- or any HER2+) who have had at least 6 months of response to systemic therapy and now show a solitary progressing metastasis; patients will receive SBRT to the progressive lesion while continuing their current systemic therapy. SBRT is delivered to the single progressing site with the intent to prolong systemic disease control.

ClinicalTrials.gov ID: NCT05534438

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

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.

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 have metastatic breast cancer with at least two untreated brain metastases (≥5 mm), are ECOG 0-1, and may continue concurrent hormonal or anti-HER2 treatment; participants receive stereotactic radiosurgery (SRS) to one lesion followed by pembrolizumab, an anti-PD-1 monoclonal antibody immunotherapy, to assess responses in non-irradiated brain lesions and systemically. Prior SRS is permitted if new lesions are targeted, and key exclusions include active autoimmune disease and recent complete CNS resection.

ClinicalTrials.gov ID: NCT03449238

This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic 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.

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 HER2-positive, PIK3CA-mutant locally advanced unresectable or metastatic breast cancer (HR+ or HR-, ECOG 0-1) previously treated with at least two HER2-directed therapies, including those with stable or treated CNS metastases. Participants receive tucatinib (HER2-selective tyrosine kinase inhibitor) plus alpelisib (PIK3CA-selective PI3K inhibitor), with the addition of fulvestrant for HR+ disease.

ClinicalTrials.gov ID: NCT05230810

A Phase I Study of M5A-IL2 Immunocytokine Combined With Stereotactic Body Radiation Therapy (SBRT) in Patients With Metastatic Colorectal Cancer or CEA-Positive Metastatic Breast Cancer

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.

HealthScout AI summary: This trial enrolls adults with metastatic, unresectable colorectal cancer or CEA-positive metastatic breast cancer who have failed standard therapy, testing the combination of stereotactic body radiation therapy (SBRT) and M5A-IL2 immunocytokine—a novel agent that targets CEA-expressing tumors by delivering interleukin-2 directly to the tumor microenvironment. Patients must have 1-5 metastatic lesions amenable to SBRT and good performance status; CNS metastases and significant comorbidities are excluded.

ClinicalTrials.gov ID: NCT06130826

A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients With ESR1 Mutations

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.

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 have metastatic or unresectable ERα-positive, HER2-negative breast cancer with ESR1 mutations and prior progression on endocrine therapy; participants receive escalating doses of oral tamoxifen, a selective estrogen receptor modulator, with FES-PET/CT imaging used to evaluate ER blockade and optimize tamoxifen dosing for this population.

ClinicalTrials.gov ID: NCT04174352

A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02)

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.

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 locally advanced, unresectable, or metastatic HER2-expressing solid tumors (excluding breast, gastric, and colorectal), including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare tumors, who have progressed after prior therapy or lack alternative options. All patients receive trastuzumab deruxtecan, a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor to HER2-expressing tumor cells.

ClinicalTrials.gov ID: NCT04482309

Phase Ib Clinical Trial of Autologous Anti-NY-ESO-1 TCR-Engineered T Cells in Patients With Relapsed/Refractory Locally Advanced or Metastatic NY-ESO-1-Expressing Triple Negative Breast Cancer

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.

HealthScout AI summary: This trial enrolls adult women with HLA-A2-positive, relapsed or refractory advanced or metastatic triple negative breast cancer that overexpresses NY-ESO-1. Participants receive autologous T cells genetically engineered to express a T-cell receptor targeting HLA-A2/NY-ESO-1 (A2-ESO-1 TCR-T cells) after lymphodepletion, followed by low-dose IL-2 to support T cell activity.

ClinicalTrials.gov ID: NCT05989828

AKTive-001: A Phase 1/1b Multiple Cohort Trial of ALTA2618 in Patients With Advanced Solid Tumors With AKT1 E17K Mutation

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: Eligible patients are adults with unresectable or metastatic solid tumors harboring the AKT1 E17K mutation who have not previously received PI3K or mTOR inhibitors and have good performance status. The study tests ALTA2618, an oral, mutation-selective covalent allosteric inhibitor of AKT1 E17K.

ClinicalTrials.gov ID: NCT06533059

A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: Adults with hormone receptor-positive, HER2-negative metastatic breast cancer—particularly those with progressive bone metastases after prior endocrine therapy (including CDK4/6 inhibitors) and ≤1 prior chemotherapy for metastatic disease—are eligible for a randomized trial comparing capecitabine plus standard anti-resorptive therapy to capecitabine plus zunsemetinib, an oral MK2 inhibitor targeting pro-inflammatory cytokine signaling.

ClinicalTrials.gov ID: NCT06374459