Clinical Trials for Breast Cancer

A Phase I/II Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced 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.

TrialFetch AI summary: Adults with measurable advanced solid tumors, ECOG 0–1, and limited treatment options receive oral VLS-1488 monotherapy; eligible cancers include high-grade serous ovarian, squamous non-small cell lung, triple-negative breast, and selected gastrointestinal, head and neck, and gynecologic tumors. VLS-1488 inhibits KIF18A, a mitotic kinesin involved in chromosome alignment.

ClinicalTrials.gov ID: NCT05902988

A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced 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.

TrialFetch AI summary: Adults with previously treated, locally advanced unresectable or metastatic melanoma, head and neck squamous cell carcinoma, non-small-cell lung cancer, triple-negative breast cancer, or classical Hodgkin lymphoma receive intravenous CTX-8371 monotherapy every 2 weeks. CTX-8371 is a bispecific antibody targeting PD-1 and PD-L1; most solid-tumor cohorts require progression after prior PD-1/PD-L1 therapy.

ClinicalTrials.gov ID: NCT06150664

Phase III Trial of Single Fraction Stereotactic Radiosurgery (SRS) Versus Fractionated SRS (FSRS) for Intact Brain Metastases

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with 1-8 intact (unresected), non-brainstem brain metastases from solid tumors (such as NSCLC, melanoma, breast, renal, or GI cancers), good performance status, and no prior brain radiotherapy are randomized to receive either single-session stereotactic radiosurgery (SRS) or fractionated SRS (three sessions). Both approaches are non-invasive, high-precision outpatient radiotherapy options for brain metastases.

ClinicalTrials.gov ID: NCT06500455

A Phase 1, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of IPH4502 as a Single Agent in 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.

TrialFetch AI summary: Adults with previously treated, unresectable locally advanced or metastatic Nectin-4–expressing solid tumors, measurable disease, and no remaining therapy with demonstrated benefit receive IPH4502 monotherapy. IPH4502 is an investigational Nectin-4–targeted antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT06781983

HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic 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.

TrialFetch AI summary: Patients with HER2-positive unresectable locally advanced or metastatic breast cancer and ECOG performance status 0–1 receive patritumab deruxtecan with trastuzumab, trastuzumab plus pertuzumab, or trastuzumab plus tucatinib. Patritumab deruxtecan is an investigational HER3-directed antibody–drug conjugate carrying a topoisomerase I inhibitor; two arms require prior progression on trastuzumab deruxtecan.

ClinicalTrials.gov ID: NCT06686394

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: This trial enrolls adults with stage IV solid tumors—including NSCLC, colorectal, breast, or bladder cancer—who are candidates for NGS testing prior to first or second-line metastatic therapy, and evaluates centralized precision oncology navigation and expert NGS review to increase use of existing targeted therapies and biomarker-driven clinical trial referrals. No investigational drugs are provided; the study focuses on optimizing precision oncology care using standard of care treatments.

ClinicalTrials.gov ID: NCT06896162

A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas

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.

TrialFetch AI summary: For adults with progressing, unresectable or recurrent advanced solid tumors or lymphomas who have no remaining standard treatment options and at least one injectable, measurable lesion, this study evaluates intratumoral ONM-501 alone or with cemiplimab. ONM-501 is an investigational STING-directed immunotherapy designed to enhance intracellular cGAMP delivery and sustain STING activation; cemiplimab inhibits PD-1.

ClinicalTrials.gov ID: NCT06022029

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced 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.

TrialFetch AI summary: Adults with advanced solid tumors harboring PIK3CA H1047R and no appropriate effective standard option receive oral OKI-219, an investigational mutant-selective PI3Kα inhibitor. Previously treated patients with HR-positive/HER2-negative or HER2-positive advanced breast cancer receive OKI-219 with fulvestrant or trastuzumab, respectively.

ClinicalTrials.gov ID: NCT06239467

A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

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.

TrialFetch AI summary: Adults with measurable, GRPR-positive, ER-positive/HER2-negative metastatic breast cancer that progressed after endocrine therapy plus a CDK4/6 inhibitor receive capecitabine with [177Lu]Lu-NeoB, an investigational GRPR-binding radioligand that delivers radiation to receptor-expressing tumors. The trial evaluates different [177Lu]Lu-NeoB doses and schedules; prior capecitabine or therapeutic radiopharmaceutical treatment is excluded.

ClinicalTrials.gov ID: NCT06247995

Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: This trial enrolls women aged 60 or older, or younger but frail, with unresectable locally advanced or metastatic HR+ HER2-negative or triple negative breast cancer who have progressed on at least one prior systemic therapy, and treats them with low-dose capecitabine (1000 mg orally once daily), a prodrug of 5-fluorouracil. The study is focused on balancing efficacy and tolerability in this higher-risk population.

ClinicalTrials.gov ID: NCT06105684