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.

TrialFetch 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.

TrialFetch 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.

TrialFetch 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 1, First-in-human, Dose Escalation and Expansion, Multicenter Study of XMT-1660 in Participants With 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.

TrialFetch AI summary: Adults with advanced, recurrent, or metastatic solid tumors (including breast, endometrial, and ovarian cancers) who have progressed on standard therapy and meet eligibility criteria are treated with XMT-1660, a B7-H4-targeted antibody-drug conjugate delivering an auristatin payload to B7-H4-positive tumor cells. Prior B7-H4 therapy or auristatin ADCs, untreated CNS metastases, and significant comorbidities are excluded.

ClinicalTrials.gov ID: NCT05377996

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