Clinical Trials for Breast Cancer

Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive 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: For patients with HER2-positive metastatic breast cancer that has progressed on trastuzumab, this single-arm study gives HER2-pulsed dendritic cell vaccines with trastuzumab and pepinemab, an investigational anti-SEMA4D antibody. Patients then receive cyclophosphamide lymphodepletion and expanded HER2-specific CD4+ T cells, followed by maintenance antibodies and booster vaccines.

ClinicalTrials.gov ID: NCT05378464

A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative 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 metastatic or inoperable locally advanced triple negative breast cancer who have received at least two prior therapies and have good performance status, treating them with a combination of daily oral tamoxifen and intravenous pegylated liposomal doxorubicin every 28 days. Pegylated liposomal doxorubicin acts as a DNA intercalator and topoisomerase II inhibitor, while tamoxifen is an estrogen receptor modulator; their combination is investigational in this setting.

ClinicalTrials.gov ID: NCT06434064

Locally AblatiVe TherApy in OLigO-pRogressive SOlid TUmorS (VALOROUS)

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 various solid tumors (including breast, gynecologic, head and neck cancers, and sarcomas) who have oligo-progressive disease (≤5 progressing metastatic lesions) despite ongoing benefit from systemic therapy; patients continue their current systemic treatment and receive locally ablative therapy (via stereotactic ablative radiotherapy or image-guided ablation) to all progressing sites.

ClinicalTrials.gov ID: NCT06103669

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (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 metastatic hormone receptor-positive, HER2-negative breast cancer who require radiation for bone metastasis, including those with prior CDK4/6 inhibitor exposure. Patients receive focal radiation therapy combined with abemaciclib, an oral CDK4/6 inhibitor that blocks cell cycle progression, with abemaciclib dose escalation to determine safety and tolerability.

ClinicalTrials.gov ID: NCT06678269

A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select 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 incurable locally advanced, recurrent, or metastatic HR-positive/HER2-negative breast, head and neck squamous cell, urothelial, or endometrial cancer harboring a PIK3CA mutation or amplification receive oral TOS-358, an investigational covalent PI3Kα inhibitor. The single-arm study escalates the dose before enrolling tumor-specific expansion cohorts.

ClinicalTrials.gov ID: NCT05683418

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation

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 progressing, measurable pancreatic, prostate, breast, or ovarian cancer and a germline BRCA2 and/or PALB2 mutation receive IV CX-5461 (pidnarulex), an investigational DNA G-quadruplex stabilizer; an exploratory cohort includes patients with high-grade ovarian, fallopian tube, or primary peritoneal cancer and BRCA1 or other HRD-associated alterations. CX-5461 is given on days 1 and 8 of each 28-day cycle, with no control arm.

ClinicalTrials.gov ID: NCT04890613

SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW 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.

TrialFetch AI summary: This trial enrolls adults with metastatic, hormone receptor positive (HR+)/HER2-low breast cancer who are endocrine-refractory and have progressed after prior trastuzumab deruxtecan (T-DXd); all participants receive sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2 and delivering SN-38, to assess its efficacy in this setting.

ClinicalTrials.gov ID: NCT06263543

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative 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 metastatic or locally advanced unresectable, ER-positive, HER2-negative breast cancer (no prior abemaciclib) to receive abemaciclib (a selective CDK4/6 inhibitor) plus standard endocrine therapy, with pre-treatment functional imaging to assess predictive biomarkers of response. Both men and premenopausal women are eligible with appropriate endocrine management.

ClinicalTrials.gov ID: NCT06179303

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents 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 metastatic or unresectable locally advanced PIK3CA-mutant solid tumors, including HR-positive breast cancer, receive STX-478, an investigational oral mutant-selective PI3Kα inhibitor, alone or with fulvestrant or other endocrine therapy plus a CDK4/6 inhibitor.

ClinicalTrials.gov ID: NCT05768139

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.

TrialFetch AI summary: Adults with advanced, refractory solid tumors and an injectable lesion receive intratumoral CAdVEC alone or followed by autologous HER2-specific CAR T cells; HER2 positivity is required only for the combination cohorts. CAdVEC is an oncolytic adenovirus designed to destroy tumor cells and deliver IL-12, PD-L1 blockade, and a safety switch.

ClinicalTrials.gov ID: NCT03740256