Clinical Trials for Breast Cancer

A Phase II Trial of Cancer Response Using Axelopran in Patients With Advanced Cancers on Opioids (AxeCan)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Single-arm study enrolling adults with advanced/metastatic prostate, breast, pancreatic, or NSCLC progressing after standard systemic therapy who are on opioids and can briefly defer next-line cancer treatment. Participants receive daily oral axelopran monotherapy, an investigational peripherally acting μ-opioid receptor antagonist intended to block GI opioid effects, with response assessed at about 6 weeks.

ClinicalTrials.gov ID: NCT07354919

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

TrialFetch AI summary: Adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer who have not received systemic therapy for advanced disease are randomized to letrozole plus BGB-43395, a selective CDK4 inhibitor, or letrozole plus investigator’s choice of abemaciclib, palbociclib, or ribociclib.

ClinicalTrials.gov ID: NCT07492641

PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial

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 eligible advanced solid tumors or breast cancer receive arm-specific combinations of evorpacept, an investigational CD47–SIRPα blocker, plus HER2-directed trastuzumab deruxtecan, or zanidatamab, a bispecific HER2 antibody, plus the HER2 kinase inhibitor tucatinib. Molecular and histologic eligibility varies by arm.

ClinicalTrials.gov ID: NCT05868226

Phase I Study of MEM-288 Oncolytic Virus Alone and in Combination With Nivolumab in Solid Tumors Including Non-Small Cell Lung Cancer (NSCLC)

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 ECOG 0–1, measurable disease, and an injectable, biopsy-accessible lesion may receive intratumoral MEM-288 alone after standard therapy for selected advanced solid tumors, or with nivolumab after first progression on frontline PD-1/PD-L1–based therapy for advanced NSCLC. MEM-288 is an oncolytic adenovirus designed to lyse tumor cells and express interferon beta and a CD40-ligand construct to stimulate antitumor immunity; nivolumab inhibits PD-1.

ClinicalTrials.gov ID: NCT05076760

A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid 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: Adults with relapsed or refractory advanced solid tumors who have exhausted or are unlikely to benefit from standard therapy receive autologous CRX100, activated immune cells carrying a tumor-selective oncolytic vaccinia virus, alone or with pembrolizumab. Eligible patients need measurable disease and ECOG performance status 0–1.

ClinicalTrials.gov ID: NCT04282044

A Phase 1 Study Evaluating the Safety, Tolerability, and Efficacy of BL-B01D1 in Subjects With Metastatic or Unresectable Non-Small Cell Lung 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.

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 study enrolls patients with incurable locally advanced or metastatic epithelial solid tumors, particularly NSCLC, who have measurable disease and ECOG performance status 0–1. Patients receive intravenous BL-B01D1 (izalontamab brengitecan), an investigational EGFR/HER3-targeting bispecific antibody–drug conjugate that delivers a topoisomerase I inhibitor, on one of two 21-day dosing schedules.

ClinicalTrials.gov ID: NCT05983432

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

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 previously treated, progressing ovarian or endometrial cancer are the main population; dose-escalation cohorts also include metastatic triple-negative breast cancer and non-small-cell lung adenocarcinoma. Patients receive intravenous farletuzumab ecteribulin (MORAb-202), an investigational FRα-targeting antibody–drug conjugate that delivers eribulin; one cohort also receives short-course corticosteroids to assess whether they reduce ILD.

ClinicalTrials.gov ID: NCT04300556

A Multi-Center Phase 2 Study of Hippocampal Avoidance in Craniospinal Irradiation for Leptomeningeal Metastases From Solid Tumors

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 targets adults with breast cancer or NSCLC with leptomeningeal metastases, using craniospinal irradiation with hippocampal avoidance via proton or VMAT to reduce neurological side effects while effectively treating the cancer. Participants require a KPS of ≥ 60 and suitable blood counts, and treatment is given over two weeks.

ClinicalTrials.gov ID: NCT06518057

A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients With Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)

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 compares proton craniospinal irradiation (pCSI) versus involved-field radiotherapy (IFRT) in adult patients with leptomeningeal metastasis from breast cancer or non-small cell lung cancer, focusing on overall survival and other CNS outcomes.

ClinicalTrials.gov ID: NCT06500481

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination with Eribulin and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ 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 unresectable or metastatic HER2-positive breast cancer who have progressed after or were intolerant to trastuzumab, a taxane, and trastuzumab deruxtecan, including those with controlled brain metastases and prior tucatinib exposure. Patients receive tucatinib (a selective HER2 tyrosine kinase inhibitor), eribulin (a microtubule inhibitor), and trastuzumab.

ClinicalTrials.gov ID: NCT05458674