Clinical Trials for Breast Cancer

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced 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.

TrialFetch AI summary: This trial enrolls adults with PIK3CA-mutated, HER2-positive locally advanced or metastatic breast cancer after first-line taxane plus Phesgo induction, randomizing them to maintenance with inavolisib (an oral PI3Kα inhibitor) plus Phesgo versus placebo plus Phesgo. Prior PI3K inhibitor use and significant comorbidities are excluded.

ClinicalTrials.gov ID: NCT05894239

A Randomized Clinical Trial Comparing ctDNA-Directed Therapy Change With Standard of Care in Patients With Metastatic 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: Adults with newly diagnosed, measurable metastatic triple negative breast cancer (PD-L1 negative or ineligible for checkpoint inhibitors, no prior chemotherapy for metastatic disease) are randomized to receive standard chemotherapy with or without early therapy switch to sacituzumab govitecan (a TROP2-targeted antibody-drug conjugate delivering SN-38) based on ctDNA dynamics versus standard imaging assessment.

ClinicalTrials.gov ID: NCT05770531

An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 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.

TrialFetch AI summary: This trial enrolls pre- and postmenopausal women and men with locally advanced or metastatic ER+/HER2- breast cancer harboring an ESR1 mutation who have progressed on prior aromatase inhibitor plus CDK4/6 inhibitor therapy, and compares lasofoxifene (an oral SERM active against ESR1-mutant tumors) plus abemaciclib to the standard regimen of fulvestrant plus abemaciclib.

ClinicalTrials.gov ID: NCT05696626

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: This trial enrolls adults with advanced or metastatic solid tumors (including HNSCC, NSCLC, colorectal, TNBC, RCC, and acral melanoma) that are refractory or resistant to standard therapies, testing the investigational HLA-G antagonist monoclonal antibody TTX-080 alone or combined with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. Control arms include standard regimens for comparison in metastatic colorectal cancer.

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: This trial enrolls adults with metastatic or unresectable HR+/HER2- breast cancer that has progressed on prior CDK4/6 inhibitor and fulvestrant therapy, allowing up to two prior chemotherapy lines. Patients receive the investigational dual RAF/MEK inhibitor VS-6766 (which allosterically inhibits both RAF and MEK to overcome resistance), in combination with standard abemaciclib and fulvestrant.

ClinicalTrials.gov ID: NCT05608252

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: This trial enrolls postmenopausal women with advanced ER+ and/or HER2+ breast cancer who have progressed after standard therapies into multiple cohorts based on subtype, randomizing them to investigational combinations featuring the oral SERD giredestrant (estrogen receptor degrader), CDK7 inhibitor samuraciclib, pan-AKT inhibitor ipatasertib, PI3K inhibitor inavolisib, HER2-targeted agents, immune checkpoint blockade (atezolizumab), and/or standard partners. Patients must have good performance status and meet strict eligibility criteria, with adaptive assignment to novel regimens as new data emerge.

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