Clinical Trials for Breast Cancer

A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)

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: Adults (women or men) with ER-positive (≥10%), HER2-negative metastatic or unresectable locally recurrent breast cancer, ECOG 0–1, measurable/evaluable disease, known ESR1 mutation status, and progression after prior CDK4/6 inhibitor–based endocrine therapy (no prior chemotherapy for metastatic disease; prior fulvestrant allowed). Patients are randomized to capecitabine alone versus capecitabine plus elacestrant (an oral selective estrogen receptor degrader that binds and promotes degradation of ER to inhibit ER signaling), with an optional switch to elacestrant monotherapy at progression for ESR1-mutant patients initially assigned to capecitabine.

ClinicalTrials.gov ID: NCT07222215

Initial Safety Lead-in Followed by a Phase II Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (The Breast CMV Study)

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: Adults with metastatic breast cancer, progressive brain metastases, and CMV viremia or seropositivity receive oral valganciclovir added to standard-of-care systemic and/or local CNS therapy, with at least one untreated progressive brain lesion followed for response. Valganciclovir is a ganciclovir prodrug that inhibits viral DNA polymerase to suppress CMV replication; its antitumor role in CMV-associated breast cancer brain metastases is investigational.

ClinicalTrials.gov ID: NCT07383649

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation

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: Enrolls first-line patients with endocrine-resistant HR+/HER2− unresectable locally advanced or metastatic breast cancer, measurable disease, centrally confirmed heterozygous chromosome 8p loss, and no PIK3CA mutation. Patients are randomized to inavolisib, an oral PI3K-alpha inhibitor, plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant.

ClinicalTrials.gov ID: NCT07405801

TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)

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: Adaptive biomarker-directed platform for adults with ER+/HER2− or triple-negative metastatic breast cancer after progression on first-line therapy, requiring an accessible metastatic lesion for biopsy. ER+/HER2− patients receive SERD-based therapy combined with abemaciclib, everolimus, or in some arms capecitabine; TNBC patients receive biomarker-directed treatment including antiandrogen therapy for AR-positive disease or standard-of-care therapy for AR-negative disease.

ClinicalTrials.gov ID: NCT07340541

A Phase II Trial of the Immunogenicity of a DNA Plasmid-Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDH3, CD105) in Patients With Metastatic Triple-Negative Breast Cancer

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.

No known activity

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

TrialFetch AI summary: Adults with PD-L1-negative, measurable metastatic triple-negative breast cancer who have received no more than one prior metastatic therapy and no prior immunotherapy in that setting receive oncologist-selected chemotherapy plus STEMVAC. This investigational plasmid DNA vaccine, given intradermally with sargramostim, encodes five breast cancer stem-cell–associated antigens and is designed to induce antigen-specific Th1 responses.

ClinicalTrials.gov ID: NCT07078604

Elacestrant in Advanced Triple Positive Breast Cancer, a Phase II Evaluation (ELATE)

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: Women with previously treated ER-positive/PR-positive/HER2-positive advanced breast cancer, including ESR1-mutated and wild-type tumors, receive oral elacestrant, a selective estrogen receptor degrader/antagonist, plus dual HER2 blockade with trastuzumab and pertuzumab.

ClinicalTrials.gov ID: NCT07612215

Phase 1 Single-arm, Open-label, Multicenter Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) 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: Premenopausal women aged 18–55 with unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer receive subcutaneous goserelin 10.8 mg every 12 weeks for 24 weeks, with stable endocrine or targeted therapy permitted. Goserelin is a GnRH agonist that suppresses pituitary LH secretion and ovarian estradiol production.

ClinicalTrials.gov ID: NCT07310420

A Single Arm, Open-label Phase Ib/II Study of Asciminib in HER2+ Breast Cancer Brain Metastases (ASCENdANT)

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: Adults with HER2-positive metastatic breast cancer and new or progressive brain metastases after at least one metastatic regimen, generally including trastuzumab deruxtecan and tucatinib, receive oral asciminib plus trastuzumab. Asciminib is an investigational allosteric ABL kinase inhibitor that binds the ABL myristoyl pocket.

ClinicalTrials.gov ID: NCT07136428

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R 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 advanced breast cancer or other solid tumors harboring PIK3CA H1047R or selected activating PIK3CA mutations receive oral LOXO-783, a mutant-selective PI3Kα inhibitor, alone or with endocrine therapy, abemaciclib, or paclitaxel. The sponsor terminated the LOXO-783 development program in 2024.

ClinicalTrials.gov ID: NCT05307705

A Phase II Study Evaluating the Efficacy and Safety of Romosozumab as a Bone-Modifying Agent in Patients With Metastatic Breast Cancer to Bones and Osteoporosis With High Fracture Risk (REMOLD-Breast)

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: Adults with hormone receptor–positive breast cancer metastatic to bone who are receiving endocrine therapy and have osteoporosis or a prior fragility fracture receive monthly subcutaneous romosozumab in this single-arm study. Romosozumab targets sclerostin to increase bone formation and reduce bone resorption.

ClinicalTrials.gov ID: NCT07776613