Clinical Trials for Breast Cancer

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced 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 HR-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed during or within 12 months of (neo)adjuvant endocrine therapy and who have not received prior systemic therapy for advanced disease; participants are randomized to receive standard fulvestrant plus a CDK4/6 inhibitor with or without gedatolisib, an investigational pan-PI3K/mTOR inhibitor that targets key resistance pathways.

ClinicalTrials.gov ID: NCT06757634

Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced 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 post-menopausal women with incurable, ER-positive metastatic or recurrent breast cancer who have progressed on at least one prior endocrine therapy, and treats them with oral 17b-estradiol (an estrogen receptor agonist) monotherapy to evaluate benefit, including in patients with tumors harboring ESR1 mutations. Concurrent anti-cancer therapies are not allowed except trastuzumab for HER2-positive disease and anti-resorptive agents.

ClinicalTrials.gov ID: NCT05716516

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)

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 ER-positive, HER2-negative unresectable or metastatic breast cancer that has progressed after prior endocrine therapy (including a CDK4/6 inhibitor), randomizing them to the HIF-2α inhibitor belzutifan plus fulvestrant versus the standard-of-care everolimus plus endocrine therapy. Belzutifan targets hypoxia-induced pathways and has a safety profile notable for anemia and hypoxia.

ClinicalTrials.gov ID: NCT06428396

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.

HealthScout 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.

HealthScout 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.

HealthScout 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 2 Clinical Trial of Talazoparib Monotherapy for PALB2 Mutation Associated Advanced 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 metastatic or recurrent HER2-negative breast cancer and a deleterious PALB2 mutation (but without BRCA1/2 mutations or prior PARP inhibitor use), treating them with talazoparib, an oral PARP1/2 inhibitor targeting homologous recombination DNA repair defects. Patients must have measurable disease, good performance status, and no recent progression on platinum therapy.

ClinicalTrials.gov ID: NCT04756765

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.

HealthScout 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 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH 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 enrolls adults with advanced solid tumors, primarily HR+/HER2- breast cancer refractory to standard therapies, and tests PF-07220060 (atirmociclib)—a selective oral CDK4 inhibitor with reduced expected hematologic toxicity—given alone or in combination with standard endocrine therapies or enzalutamide. Select other tumor types, including HR+/HER2+ breast cancer, NSCLC, prostate, colorectal cancer, liposarcoma, and CDK4/CCND1-amplified tumors, are also eligible.

ClinicalTrials.gov ID: NCT04557449

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.

HealthScout 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