Clinical Trials for Breast Cancer

An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)

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 measurable advanced or metastatic solid tumors and ECOG 0–1 receive GI-102 alone or with selected anticancer agents; a dose-optimization cohort focuses on checkpoint inhibitor–refractory metastatic melanoma after at least one prior line of therapy. GI-102 is an investigational CD80–IL-2 variant fusion protein designed to block CTLA-4 signaling and stimulate CD8 T and natural killer cells; combination partners include doxorubicin, paclitaxel/bevacizumab, eribulin, pembrolizumab, and trastuzumab deruxtecan.

ClinicalTrials.gov ID: NCT05824975

A Phase 1a/1b Multicenter, Open-label Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of PLN-101095 as Monotherapy and in Combination With Pembrolizumab in Adult Participants With Advanced or Metastatic Solid Tumors Who Have Disease Progression While on Pembrolizumab

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 measurable advanced or metastatic solid tumors that progressed after at least 3 months of pembrolizumab, and who have no effective treatment options, receive oral PLN-101095 alone or with continued pembrolizumab. PLN-101095 inhibits αvβ8 and αvβ1 integrins to reduce activation of immunosuppressive TGF-β in the tumor microenvironment.

ClinicalTrials.gov ID: NCT06270706

A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal 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 solid tumors (excluding CNS primaries and radiosensitive histologies) who have up to three contiguous vertebral levels of spinal metastases and minimal neurological deficit, treating them with spine-directed stereotactic body radiation therapy (SBRT) as definitive therapy instead of surgery. Prior intervention to the target site, unstable spines, and radiosensitive tumors are excluded.

ClinicalTrials.gov ID: NCT06165419

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant 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.

TrialFetch AI summary: Adults with advanced or metastatic refractory/resistant solid tumors, including selected colorectal, head and neck, lung, breast, renal, and acral melanoma cohorts, receive TTX-080, an investigational HLA-G–blocking antibody, alone or with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. A colorectal cancer cohort compares FOLFIRI plus cetuximab with or without TTX-080.

ClinicalTrials.gov ID: NCT04485013

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable 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 HR+ HER2- metastatic or unresectable breast cancer starting first-line endocrine therapy plus a CDK4/6 inhibitor; patients are monitored using the DiviTum TKa assay, with early therapeutic switching to second-line treatment recommended for those whose thymidine kinase activity is not suppressed after two weeks. The study investigates whether this biomarker-guided approach can optimize progression-free survival and imaging schedules.

ClinicalTrials.gov ID: NCT05977036

A Single Arm Phase 1/2 Trial of Abemaciclib + VS-6766 + Fulvestrant in Metastatic HR+/HER2- 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.

TrialFetch AI summary: Adults with HR-positive, HER2-negative metastatic or unresectable locally recurrent breast cancer who have progressed on a CDK4/6 inhibitor regimen and fulvestrant receive VS-6766 (avutometinib), a RAF/MEK inhibitor, with abemaciclib and fulvestrant. Eligible patients must have ECOG performance status 0–1; stable, treated brain metastases are permitted.

ClinicalTrials.gov ID: NCT05608252

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed Against HER2/HER3 in Patients With Leptomeningeal Disease (LMD) From Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

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: This trial enrolls adults with leptomeningeal disease from either triple-negative or HER2-positive breast cancer, using an intrathecal dendritic cell vaccine pulsed with HER2/HER3 peptides to stimulate an anti-tumor immune response in the CNS. Eligible patients must have an Ommaya reservoir or equivalent device for vaccine administration.

ClinicalTrials.gov ID: NCT05809752

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-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.

TrialFetch AI summary: For patients with inoperable locally advanced or metastatic ER-positive breast cancer, treatment cohorts include HER2-negative disease after CDK4/6 inhibitor–containing endocrine therapy, HER2-positive disease after trastuzumab–taxane and HER2-directed therapy, and HER2-negative, PIK3CA-mutated disease recurring during or shortly after adjuvant endocrine therapy. Arms test giredestrant, an investigational oral estrogen receptor degrader, alone or with CDK4/6, PI3K, AKT, mTOR, or CDK7 inhibitors, atezolizumab, and/or pertuzumab–trastuzumab, depending on cohort.

ClinicalTrials.gov ID: NCT04802759

Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive 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 biopsy-proven estrogen receptor (ER)-positive breast cancer and new or recurrent brain metastases who are candidates for planned radiation therapy, using investigational brain imaging with 18F-FES PET/CT (a radiotracer targeting ER expression) in addition to standard imaging to potentially enhance radiotherapy planning and response assessment.

ClinicalTrials.gov ID: NCT06072807

A Phase IA/IB Trial of Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 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 advanced or metastatic solid tumors harboring PTEN loss/mutation or those with HER2 negative breast cancer who have progressed on standard therapies; patients receive oral leflunomide, a DHODH inhibitor targeting de novo pyrimidine synthesis, to assess safety and preliminary anti-tumor activity. Patients may have had prior chemotherapy, targeted therapy, and treated/stable brain metastases; those with primary CNS tumors or active hepatitis are excluded.

ClinicalTrials.gov ID: NCT04997993