Clinical Trials for Breast Cancer

A Phase 2 Study of TheraBionic P1 Device for Patients With Metastatic Hormone Positive Breast Cancer Post Endocrine Therapy

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: Women aged 22 or older with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer are eligible after progression on or intolerance to endocrine therapy plus a CDK4/6 inhibitor and at least one cytotoxic therapy. Participants self-administer the TheraBionic P1 device three times daily; it delivers amplitude-modulated electromagnetic fields, with no specified molecular target.

ClinicalTrials.gov ID: NCT07227831

Image-Guided Pulsed Electric Field (PEF) Ablation of Soft Tissue Lesions in Metastatic Breast Cancer: 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: Adults with metastatic breast cancer and 1–3 image-accessible cutaneous or subcutaneous lesions (1–5 cm) receive a single image-guided ablation using the Aliya Pulsed Electric Field System. This nonthermal treatment uses brief electrical pulses to disrupt tumor-cell membranes; patients must be able to pause systemic therapy around the procedure.

ClinicalTrials.gov ID: NCT07487844

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)

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.

TrialFetch AI summary: The INSIGHT trial investigates early chemotherapy with capecitabine versus endocrine-based therapy in patients with non-Luminal A hormone receptor-positive metastatic breast cancer who have previously been treated with aromatase inhibitors, CDK4/6 inhibitors, or selective estrogen receptor modulators/downregulators, but not chemotherapy in the metastatic setting. The study aims to evaluate the anti-tumor effects, safety, and tolerability of these treatments while assessing cfDNA mutations as early indicators of response and potential genomic alterations linked to treatment resistance.

ClinicalTrials.gov ID: NCT05693766

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC) and Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC)

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.

TrialFetch AI summary: This trial enrolls adults with HER2-positive metastatic breast, gastric, gastroesophageal junction, or esophageal adenocarcinoma who have progressed after standard therapy, testing the selective HER2 tyrosine kinase inhibitor zongertinib (BI 1810631) alone or in combination with HER2-targeted agents (T-DXd, T-DM1, trastuzumab, capecitabine). Eligible patients must have measurable disease and good performance status (ECOG 0-1).

ClinicalTrials.gov ID: NCT06324357

PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung 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.

TrialFetch AI summary: This trial enrolls adults with oligometastatic breast cancer (all subtypes) or non-small cell lung cancer (1-5 measurable metastases) who are randomized to receive either standard systemic therapy or standard systemic therapy plus stereotactic body radiotherapy (SBRT) to all metastatic sites. Eligible patients may have newly diagnosed or stable metastatic disease and must have lesions suitable for SBRT or local therapy.

ClinicalTrials.gov ID: NCT03808337

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue 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.

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: This trial enrolls adults with advanced or metastatic solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected 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

TrialFetch AI summary: Adults with ECOG 0–1 and selected unresectable or metastatic solid tumors without a standard treatment option receive oral APL-5125, an investigational CK2α inhibitor. The expansion cohort focuses on colorectal cancer after fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy, plus anti-EGFR therapy for RAS-wild-type disease.

ClinicalTrials.gov ID: NCT06399757

Single Arm Study to Assess the Immune Effects of Fermented Wheat Germ (FWG) Nutritional Supplementation in Patients With Advanced Malignancies Being Treated With Standard of Care Checkpoint Inhibitor-Based Therapy

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.

TrialFetch AI summary: Adults with advanced non-small cell lung, renal cell, melanoma, colorectal, or triple-negative breast cancers eligible for standard checkpoint inhibitor immunotherapy will receive oral fermented wheat germ supplementation (a nutritional product with proposed but unproven immunomodulatory effects) alongside their standard immunotherapy regimen. No chemotherapy, radiotherapy, or recent immunomodulatory agents are allowed prior to enrollment.

ClinicalTrials.gov ID: NCT05967533

Phase II Trial of Photon Craniospinal Irradiation for Leptomeningeal Disease Secondary to Solid Tumor Malignancy

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.

TrialFetch AI summary: This trial enrolls adults with leptomeningeal disease secondary to breast cancer or non-small cell lung cancer who have adequate performance status and organ function, and treats them with photon craniospinal irradiation using VMAT, an advanced conformal radiation therapy technique. All patients receive 10 fractions of CSI over 10 to 20 days to assess efficacy and safety in controlling central nervous system progression.

ClinicalTrials.gov ID: NCT06910761

Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated 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.

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: This trial enrolls adults with recurrent or second primary tumors in body sites previously treated with radiotherapy—including CNS, head and neck, breast, thoracic, GI, GU, and gynecological cancers—to evaluate reirradiation using pencil beam scanning proton therapy, which aims to provide effective tumor control with reduced toxicity compared to standard photon techniques. No investigational drugs are included, and some cohorts may not allow concurrent chemotherapy.

ClinicalTrials.gov ID: NCT05313191