Clinical Trials for Breast Cancer

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.

TrialFetch 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.

TrialFetch 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.

TrialFetch AI summary: Adults with previously treated, unresectable or metastatic HER2-expressing or HER2-amplified solid tumors receive trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate carrying a topoisomerase I inhibitor, plus the oral ATR inhibitor ceralasertib. Expansion cohorts are limited to patients with gastroesophageal or colorectal cancer and a biopsiable lesion.

ClinicalTrials.gov ID: NCT04704661

A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia

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 study enrolls adults with advanced solid tumors lacking beneficial standard options or relapsed/refractory AML without suitable standard options, with expansion cohorts for previously treated metastatic triple-negative breast cancer and gastric/gastroesophageal junction adenocarcinoma. Patients receive intravenous BAL0891, an investigational TTK/MPS1 and PLK1 inhibitor, alone or, for solid tumors, with carboplatin or paclitaxel.

ClinicalTrials.gov ID: NCT05768932

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.

TrialFetch 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.

TrialFetch 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 Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Metastatic Breast Cancer (Morpheus-panBC)

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 inoperable locally advanced breast cancer are assigned by subtype and treatment history to regimens for PD-L1-positive or previously treated TNBC, PIK3CA-mutated HR-positive/HER2-negative disease, or PIK3CA-mutated HER2-positive/HER2-low disease. Treatments include atezolizumab-based combinations or capecitabine for TNBC, as well as investigational AKT inhibitor ipatasertib, LIV-1–directed antibody–drug conjugate ladiratuzumab vedotin, or CD40 agonist selicrelumab; PIK3CA-mutated cohorts receive investigational PI3K inhibitor inavolisib with endocrine/CDK4/6 therapy or trastuzumab deruxtecan.

ClinicalTrials.gov ID: NCT03424005

A Study of PARG Inhibitor IDE161 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 non-CNS solid tumors and a BRCA1/2 or other specified homologous-recombination repair alteration receive the investigational oral PARG inhibitor IDE161 alone after progression on or intolerance to standard therapy. A separate cohort with recurrent or advanced endometrial cancer progressing after anti-PD-1/PD-L1 therapy receives IDE161 plus pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable,or Metastatic Triple-negative Breast Cancer (TNBC)or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 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: Adults with untreated, locally advanced/inoperable or metastatic TNBC (PD‑L1–ineligible or contraindicated for anti–PD-(L)1) or ER-low, HER2‑negative breast cancer ineligible for endocrine therapy, with measurable disease, are randomized to izalontamab brengitecan (BMS‑986507)—a bispecific EGFR/HER3-targeted antibody‑drug conjugate delivering a topoisomerase I inhibitor—versus physician’s choice of paclitaxel, nab‑paclitaxel, capecitabine, or carboplatin/gemcitabine. Key efficacy is assessed by blinded central review, with PFS primary and OS/ORR secondary.

ClinicalTrials.gov ID: NCT06926868

Phase 1 Clinical Trial of Avasopasem in Patients With Metastatic Hormone Receptor Positive Breast Cancer With Progression on a CDK 4/6 Inhibitor and Hormonal Therapy (CTMS# 24-0096)

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 HR-positive, HER2-negative metastatic breast cancer who have radiographic progression on a CDK4/6 inhibitor plus endocrine therapy (ribociclib or abemaciclib with an AI or fulvestrant) continue their current regimen with the addition of avasopasem, a small-molecule superoxide dismutase mimetic that modulates reactive oxygen species. Includes patients with treated/stable brain metastases; excludes current palbociclib and tamoxifen users and those requiring strong CYP3A4 modulators.

ClinicalTrials.gov ID: NCT07137871