Clinical Trials for Breast Cancer

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

An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, and Pharmacokinetics of BTX A51 Alone and in Combination With Fulvestrant in Subjects With Advanced Solid Tumors and Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative 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.

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 solid tumors or ER-positive, HER2-negative metastatic breast cancer who are refractory to standard therapy, evaluating the novel oral multi-kinase inhibitor BTX-A51 (targeting CK1α, CDK7, and CDK9) alone or with fulvestrant. Patients must have adequate organ function and no significant comorbidities.

ClinicalTrials.gov ID: NCT04872166

A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

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 relapsed or metastatic solid tumors—particularly breast, ovarian, endometrial, biliary tract, and squamous NSCLC—who have received prior therapy, evaluating the antibody-drug conjugate AZD8205 (targets B7-H4 and delivers a topoisomerase I inhibitor) as monotherapy or in combination with the PD-1/TIGIT bispecific antibody rilvegostomig or the PARP inhibitor saruparib. Eligible patients must have measurable disease, ECOG 0-1, and adequate organ function, with some sub-studies focusing on select tumor types.

ClinicalTrials.gov ID: NCT05123482

A Phase 1 Study of SGN-B6A 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.

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 metastatic or unresectable solid tumors (including NSCLC, HNSCC, HER2-negative breast, esophageal, cutaneous SCC, ovarian, bladder, cervical, pancreatic, and gastric cancers), evaluating the antibody-drug conjugate sigvotatug vedotin—targeting integrin beta-6—with or without pembrolizumab and/or platinum chemotherapy. Eligibility varies by cohort, including both treatment-naïve and previously treated/refractory patients, with fresh or recent tumor biopsy required in some arms.

ClinicalTrials.gov ID: NCT04389632

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/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.

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 or metastatic solid tumors expressing HER2 (including HER2-low), who are refractory or intolerant to standard therapies, receive the investigational HER2-targeted antibody-drug conjugate DB-1303/BNT323 (anti-HER2 IgG1 linked to a DNA topoisomerase I inhibitor) IV every 3 weeks; select cohorts also examine combinations with pertuzumab or CYP inhibitors for drug-drug interaction assessment.

ClinicalTrials.gov ID: NCT05150691

Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/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.

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: Eligible patients are adults with locally advanced or metastatic solid tumors (including ovarian, endometrial, non-small cell lung, breast cancer, and mesothelioma) who have progressed after standard therapies, with cohorts defined by tumor type, platinum sensitivity, and folate receptor alpha (FRα) status. The trial investigates Rina-S (rinatabart sesutecan), a folate receptor alpha-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor, as monotherapy and in combination with carboplatin, bevacizumab, or pembrolizumab depending on cohort.

ClinicalTrials.gov ID: NCT05579366

A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With 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.

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 or metastatic solid tumors who have progressed on, or are not candidates for, standard therapies (including anti-PD-1 where appropriate) may be eligible for this trial of BMS-986340, an investigational anti-CCR8 monoclonal antibody targeting tumor-infiltrating regulatory T cells, given as monotherapy or in combination with nivolumab or docetaxel. Patients must have measurable disease, ECOG 0-1, and be able to undergo mandatory tumor biopsies.

ClinicalTrials.gov ID: NCT04895709

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

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: Eligible patients have locally advanced or metastatic solid tumors with HER2 expression—including NSCLC, breast (both HER2+ and HER2-), urothelial, gastric, esophageal, or other Erbb2-amplified cancers—who have progressed on or are intolerant to standard treatments. Patients receive DF1001, a tri-specific NK cell engager targeting HER2 and activating NK and T cells, as monotherapy or in combination with nivolumab, nab-paclitaxel, or sacituzumab govitecan-hziy.

ClinicalTrials.gov ID: NCT04143711

A Pilot Study of Spatially Fractionated Radiation Therapy in Patients with Extra-Cranial Soft Tissue 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 advanced or metastatic solid tumors and at least two extracranial soft tissue metastases (one ≥4 cm) requiring palliative radiation, comparing lattice radiation therapy (LRT)—a spatially fractionated radiotherapy technique that may enhance immune effects—to standard SBRT, with each patient receiving both treatments at different sites.

ClinicalTrials.gov ID: NCT05837767