Clinical Trials for Breast Cancer

Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced 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 locally advanced, inoperable triple negative breast cancer who have at least one lesion suitable for cryoablation and are eligible for pembrolizumab, a PD-1 inhibitor. It compares pembrolizumab alone to pembrolizumab combined with cryoablation to assess whether the addition of local ablation enhances immune response.

ClinicalTrials.gov ID: NCT06246968

A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, or Are Intolerant to, Previous Trastuzumab Deruxtecan Treatment

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 on or are intolerant to prior trastuzumab deruxtecan, randomizing them to zanidatamab (a bispecific anti-HER2 antibody) plus physician’s choice chemotherapy versus trastuzumab plus physician’s choice chemotherapy. Patients may have stable or treated CNS metastases, and chemotherapy options include eribulin, vinorelbine, gemcitabine, or capecitabine.

ClinicalTrials.gov ID: NCT06435429

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW 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 AR-positive triple-negative or ER-low breast cancer (≥10% AR by IHC), randomized to receive either enzalutamide (androgen receptor inhibitor), enzalutamide plus mifepristone (glucocorticoid receptor antagonist), or standard single-agent chemotherapy. Patients may have received up to two prior metastatic chemotherapy lines and may cross over to the investigational arm at progression if eligible.

ClinicalTrials.gov ID: NCT06099769

Primary Breast Oligoprogressive Sites Treated With Radiotherapy to Obviate the Need to Change Systemic Therapy (BOSS)

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 adult women with metastatic, non–triple-negative breast cancer who have 1-3 extracranial oligoprogressive lesions despite ongoing benefit from current systemic therapy, treating these lesions with stereotactic body radiotherapy (SBRT) while patients remain on their existing systemic regimen. Eligible patients must have adequate performance status, no active CNS disease, and no more than three extracranial progressing sites.

ClinicalTrials.gov ID: NCT06055881

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE)

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 postmenopausal women with ER+/HER2- metastatic or recurrent breast cancer who have progressed after CDK4/6 inhibitor therapy, assigning patients to combinations of fulvestrant with targeted agents (neratinib for ERBB2 mutations, alpelisib for PIK3CA mutations, everolimus for AKT1/MTOR/PTEN alterations, or abemaciclib for others) based on tumor genetic profiling. Targeted agents address specific molecular drivers: neratinib (pan-HER TKI), alpelisib (PI3K alpha inhibitor), everolimus (mTOR inhibitor), and abemaciclib (CDK4/6 inhibitor).

ClinicalTrials.gov ID: NCT05933395

A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab Deruxtecan as Induction Treatment for HER2+ Unresectable Locally Recurrent or 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 HER2-positive unresectable locally recurrent or metastatic breast cancer (ECOG 0-1) who have not received prior chemotherapy or HER2-targeted therapy for advanced disease, and tests intravenous trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor) as induction, followed by maintenance therapy with subcutaneous fixed-dose pertuzumab and trastuzumab (PHESGO).

ClinicalTrials.gov ID: NCT06172127

Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced 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 breast cancer strictly classified as HER2-IHC 0 (never HER2-positive or HER2-low), who have received 1–2 prior lines of systemic therapy and no prior anti-HER2 therapy, to evaluate trastuzumab deruxtecan (T-DXd), a HER2-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor, given IV every 3 weeks.

ClinicalTrials.gov ID: NCT06750484

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: This trial enrolls adults with metastatic HER2-positive breast cancer who have progressed on trastuzumab and received up to three prior chemotherapy lines, and tests sequential treatment with HER2-pulsed dendritic cell vaccine, trastuzumab, and pepinemab (a SEMA4D inhibitor) followed by adoptive transfer of ex vivo expanded, HER2-specific CD4+ Th1 cells. Booster vaccines and continued trastuzumab/pepinemab maintenance follow adoptive cell infusion.

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