Clinical Trials for Breast Cancer

Phase 1b/2 Open-label Trial of 225Ac-DOTATATE (RYZ101) in Subjects with Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)-negative, Locally Advanced and Unresectable or Metastatic Breast Cancer Expressing Somatostatin Receptors (SSTRs) and Progressed After Antibody-drug Conjugates And/or Chemotherapy (TRACY-1).

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.

HealthScout AI summary: This trial enrolls adults with ER+, HER2-negative unresectable or metastatic breast cancer expressing somatostatin receptors (by SSTR-PET) who have progressed after antibody-drug conjugates and/or chemotherapy, and evaluates RYZ101 (225Ac-DOTATATE), an SSTR-targeted alpha-emitting radiopharmaceutical. Patients must have no prior radiopharmaceutical therapy and meet standard organ function criteria.

ClinicalTrials.gov ID: NCT06590857

A Phase 1 Study of SGN-PDL1V 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.

HealthScout AI summary: This trial enrolls adults with metastatic or unresectable, PD-L1–expressing solid tumors (including NSCLC, HNSCC, esophageal SCC, TNBC, ovarian cancer, melanoma, and gastric cancer) who have failed or are ineligible for standard therapies. Patients receive either SGN-PDL1V, an antibody-drug conjugate targeting PD-L1 and delivering MMAE, or a combination of SGN-PDL1V plus pembrolizumab.

ClinicalTrials.gov ID: NCT05208762

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.

HealthScout 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

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.

HealthScout AI summary: This study enrolls adults with HER2-positive unresectable locally advanced or metastatic breast cancer who have received at least two prior lines of anti-HER2 therapy, and evaluates patritumab deruxtecan (a HER3-directed antibody-drug conjugate) in combination with standard anti-HER2 therapies (trastuzumab with or without pertuzumab or tucatinib). Eligibility excludes those with active CNS metastases and certain comorbidities.

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.

HealthScout 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 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other 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.

HealthScout AI summary: This trial enrolls patients aged 12 and older with metastatic or unresectable NUT carcinoma, breast cancer, or other solid tumors who have no standard treatments remaining, including those previously treated with BET or CDK4/6 inhibitors. Participants receive oral ZEN003694, an investigational BET bromodomain inhibitor targeting oncogenic gene transcription, in combination with the CDK4/6 inhibitor abemaciclib.

ClinicalTrials.gov ID: NCT05372640

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic cancers—specifically HR+/HER2- breast cancer resistant to prior CDK4/6 inhibitors, platinum-resistant/refractory ovarian cancers with CCNE1 amplification, and other CCNE1-amplified solid tumors—treating them with INX-315, an oral selective CDK2 inhibitor, as monotherapy or in combination with fulvestrant and abemaciclib. Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT05735080

A Phase 1b Trial of ZEN003694 (ZEN-3694) With Pembrolizumab and Nab-Paclitaxel in Patients With Metastatic Triple-Negative 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.

HealthScout AI summary: This trial enrolls adults with unresectable locally advanced or metastatic triple-negative breast cancer—including those with stable CNS metastases—to receive a combination of the BET bromodomain inhibitor ZEN003694 (targets epigenetic regulation), pembrolizumab, and nab-paclitaxel. Dose escalation includes any prior therapy and PD-L1 status, while expansion focuses on PD-L1–negative patients with limited prior lines and biopsy-accessible disease.

ClinicalTrials.gov ID: NCT05422794

A Phase 1/2, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Anti-tumor Activity of TNG462 as a Single Agent and in Combination in Patients With MTAP-deleted Advanced or Metastatic 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.

HealthScout AI summary: Adults with advanced or metastatic solid tumors harboring homozygous MTAP deletions who have progressed on standard therapy are eligible for treatment with TNG462, a selective PRMT5 inhibitor targeting MTAP-deleted tumor cells, either as monotherapy or in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT05732831

Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative 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.

HealthScout AI summary: This trial enrolls adults with relapsed or refractory triple-negative breast cancer (TNBC) and tests autologous iC9-CAR.B7-H3 T cell therapy, a CAR-T product targeting the B7-H3 antigen with an inducible caspase 9 safety switch, after lymphodepleting chemotherapy. Patients with symptomatic CNS metastases or other interfering cancers are excluded.

ClinicalTrials.gov ID: NCT06347068