Clinical Trials for Breast Cancer

BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable 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 HR+ HER2- metastatic or unresectable breast cancer starting first-line endocrine therapy plus a CDK4/6 inhibitor; patients are monitored using the DiviTum TKa assay, with early therapeutic switching to second-line treatment recommended for those whose thymidine kinase activity is not suppressed after two weeks. The study investigates whether this biomarker-guided approach can optimize progression-free survival and imaging schedules.

ClinicalTrials.gov ID: NCT05977036

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-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 postmenopausal women with advanced ER+ and/or HER2+ breast cancer who have progressed after standard therapies into multiple cohorts based on subtype, randomizing them to investigational combinations featuring the oral SERD giredestrant (estrogen receptor degrader), CDK7 inhibitor samuraciclib, pan-AKT inhibitor ipatasertib, PI3K inhibitor inavolisib, HER2-targeted agents, immune checkpoint blockade (atezolizumab), and/or standard partners. Patients must have good performance status and meet strict eligibility criteria, with adaptive assignment to novel regimens as new data emerge.

ClinicalTrials.gov ID: NCT04802759

Brain [18F]-FES PET/CT in the Diagnosis, Treatment Planning and Response Assessment of Brain Metastases in Patients With Estrogen-Receptor Positive 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 biopsy-proven estrogen receptor (ER)-positive breast cancer and new or recurrent brain metastases who are candidates for planned radiation therapy, using investigational brain imaging with 18F-FES PET/CT (a radiotracer targeting ER expression) in addition to standard imaging to potentially enhance radiotherapy planning and response assessment.

ClinicalTrials.gov ID: NCT06072807

A Phase IA/IB Trial of Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic solid tumors harboring PTEN loss/mutation or those with HER2 negative breast cancer who have progressed on standard therapies; patients receive oral leflunomide, a DHODH inhibitor targeting de novo pyrimidine synthesis, to assess safety and preliminary anti-tumor activity. Patients may have had prior chemotherapy, targeted therapy, and treated/stable brain metastases; those with primary CNS tumors or active hepatitis are excluded.

ClinicalTrials.gov ID: NCT04997993

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative 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.

HealthScout AI summary: This trial enrolls adults with endocrine-sensitive, PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced or metastatic breast cancer who are treatment-naïve for advanced disease, evaluating inavolisib (a selective PI3Kα inhibitor) in combination with a CDK4/6 inhibitor and letrozole versus placebo with standard therapy. Key exclusions include prior systemic therapy for advanced disease and untreated CNS metastases.

ClinicalTrials.gov ID: NCT06790693

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative 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: Eligible patients are adults with unresectable, locally advanced, or metastatic ER-positive, HER2-negative breast cancer who have progressed on prior endocrine therapy with a CDK4/6 inhibitor (allowing up to two prior lines of chemotherapy and stable treated brain metastases), receiving lenvatinib (VEGFR/FGFR/PDGFRα/RET/KIT inhibitor) plus pembrolizumab (PD-1 inhibitor) and fulvestrant. Both premenopausal (with ovarian suppression) and postmenopausal women, as well as men, are eligible.

ClinicalTrials.gov ID: NCT06110793

Phase 1/1B Study of DS-8201a in Combination With ATR Inhibition (AZD6738) in Advanced Solid Tumors With HER2 Expression (DASH 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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic HER2-expressing solid tumors—particularly colorectal and gastroesophageal cancers after progression on standard therapy—and evaluates intravenous trastuzumab deruxtecan (a HER2-targeted antibody-drug conjugate) in combination with oral ceralasertib (a selective ATR kinase inhibitor targeting DNA damage response pathways).

ClinicalTrials.gov ID: NCT04704661

A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)

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 or metastatic breast cancer that is HER2-low (IHC 1+ or 2+/ISH-) or HER2 IHC 0 (regardless of hormone receptor status), who have had 1-2 prior lines of therapy but no prior anti-HER2 agents or antibody-drug conjugates in the metastatic setting. All patients receive trastuzumab deruxtecan (T-DXd), an antibody-drug conjugate delivering a topoisomerase I inhibitor to HER2-expressing tumor cells, to assess clinical benefit and safety.

ClinicalTrials.gov ID: NCT05950945

A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive 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 estrogen receptor positive (ER+) metastatic breast cancer and 1–4 sites of extracranial oligoprogressive disease who are candidates for SBRT to all progressing lesions. Participants receive stereotactic body radiation therapy to progressive sites while remaining on their current systemic therapy, and undergo F-18 fluoroestradiol PET/CT imaging to guide detection and monitoring of ER+ lesions.

ClinicalTrials.gov ID: NCT06260033

A Phase 1 Study of ZEN003694 in Combination With Binimetinib in Solid Tumors With RAS Pathway Alterations and Triple 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: Eligible patients are adults with advanced or metastatic solid tumors harboring RAS pathway alterations (KRAS, NRAS, HRAS, BRAF, or NF1), including those with triple negative breast cancer, who have progressed after standard therapy. Treatment consists of the BET inhibitor ZEN003694 (targets transcriptional regulation) in combination with the MEK inhibitor binimetinib, both given orally.

ClinicalTrials.gov ID: NCT05111561