Clinical Trials for Breast Cancer

The STOP-HER2 Trial: a Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients with HER2+ 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 unresectable locally advanced or metastatic HER2-positive breast cancer (both ER-positive and ER-negative) who have been progression-free for at least three years on first-line anti-HER2 therapy, including those with controlled brain-only or limited progression. It evaluates the safety of discontinuing anti-HER2 therapies such as trastuzumab in these exceptional responders.

ClinicalTrials.gov ID: NCT05721248

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases From Breast Carcinoma Involving the Spine

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 metastatic breast cancer and MRI/CSF-confirmed spinal leptomeningeal metastases receive tumor treating fields (TTF) therapy using the portable NovoTTF-200T device, a noninvasive treatment that disrupts tumor cell division via alternating electric fields. No concurrent high-dose intrathecal or CNS-directed cytotoxic therapy is allowed.

ClinicalTrials.gov ID: NCT05746325

A Phase I Dose Escalation / Dose Expansion Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated with an Anti-PD-1 Therapy

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 patients with advanced, injectable metastatic or recurrent head and neck squamous cell carcinoma, NSCLC, melanoma, hepatocellular, renal, urothelial, cervical, or triple-negative breast cancer—regardless of anti-PD-1 status—to receive a single intratumoral injection of NBTXR3 (a hafnium oxide nanoparticle radioenhancer) activated by SABR, followed by anti-PD-1 therapy with nivolumab or pembrolizumab.

ClinicalTrials.gov ID: NCT03589339

A First in Human Phase I Trial of Binary Oncolytic Adenovirus in Combination With HER2-Specific Autologous CAR T Cells in Patients With Advanced HER2 Positive 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: Eligible adult patients have advanced, refractory HER2-positive solid tumors with at least one injectable lesion. The trial evaluates safety and preliminary efficacy of intratumoral CAdVEC, an oncolytic adenovirus expressing IL-12 and a PD-L1 blocker, alone or in combination with intravenous HER2-specific autologous CAR T cells at higher dose levels.

ClinicalTrials.gov ID: NCT03740256

HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic 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.

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: Adults with metastatic breast cancer (up to one prior line of metastatic therapy) are eligible to have their tumor tissue analyzed using PAM50 RNA-based molecular subtyping, with results shared with their treating oncologist to inform and potentially change treatment planning; no investigational drugs are administered.

ClinicalTrials.gov ID: NCT03769415

An Open-Labeled, Single Arm Phase 2 Efficacy and Safety Study of REM-001 Photodynamic Therapy (PDT) for Treatment of Cutaneous Metastatic Breast Cancer (CMBC) That is Refractory or Not Eligible for Radiotherapy or Surgery

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 cutaneous metastatic breast cancer refractory to or ineligible for surgery or radiotherapy, with stable systemic disease and progression on at least two prior systemic treatments, receive REM-001 photodynamic therapy—a photosensitizer activated by light to locally ablate tumor tissue via reactive oxygen species generation.

ClinicalTrials.gov ID: NCT05374915

A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, As a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients 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.

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 PIK3CA-mutated solid tumors—including HR+ HER2- breast cancer and endometrial cancer—to receive the mutant-selective PI3Kα inhibitor RLY-2608 (oral, allosteric, isoform- and mutant-specific) as monotherapy or in combination with fulvestrant, CDK4/6 inhibitors, or the investigational CDK4-only inhibitor PF-07220060. Eligible patients include those who are refractory or intolerant to standard therapies, including prior endocrine and CDK4/6 inhibitor treatments.

ClinicalTrials.gov ID: NCT05216432

Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ 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 HER2-positive locally advanced or metastatic breast cancer and measurable disease who have received prior anti-HER2 therapy, excluding those with prior anthracycline use or significant cardiac issues. Patients receive tucatinib, a selective HER2 tyrosine kinase inhibitor, in combination with Doxil (pegylated liposomal doxorubicin).

ClinicalTrials.gov ID: NCT05748834

An Open-Label, Phase 1/2 Study of ORIC-114 As a Single Agent or in Combination with Chemotherapy, in Patients with Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

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: Eligible patients have advanced or metastatic solid tumors (including NSCLC and breast cancer) with EGFR exon 20 insertions, atypical EGFR mutations, HER2 exon 20 insertions, or HER2 amplification/overexpression, who have progressed after standard therapies or are unsuitable for them. The trial evaluates ORIC-114, an oral, CNS-penetrant, irreversible EGFR/HER2 inhibitor, as monotherapy or combined with carboplatin/pemetrexed chemotherapy.

ClinicalTrials.gov ID: NCT05315700

Phase 1 Pilot Study With Dose Expansion of Chemotherapy in Combination With CD40 Agonist and Flt3 Ligand in Metastatic HER2 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.

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 unresectable stage III or IV HER2 negative metastatic breast cancer (including both triple negative and hormone receptor positive disease) who have progressed after prior therapy, testing the combination of pegylated liposomal doxorubicin with the CD40 agonist antibody CDX-1140 and the Flt3 ligand CDX-301 (a dendritic cell growth factor) to evaluate safety and early efficacy. All participants ultimately receive all three agents, with sequencing varying by cohort.

ClinicalTrials.gov ID: NCT05029999