Clinical Trials for Breast Cancer

Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

HealthScout AI summary: This trial enrolls women aged 60 or older, or younger but frail, with unresectable locally advanced or metastatic HR+ HER2-negative or triple negative breast cancer who have progressed on at least one prior systemic therapy, and treats them with low-dose capecitabine (1000 mg orally once daily), a prodrug of 5-fluorouracil. The study is focused on balancing efficacy and tolerability in this higher-risk population.

ClinicalTrials.gov ID: NCT06105684

Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic 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.

HealthScout AI summary: Adults with metastatic or locally advanced HER2 low, ultra-low, or null breast cancer (IHC 1+/2+/0, ISH-) who have progressed on prior endocrine therapy (if HR+) and at least one line of chemotherapy receive valemetostat, an oral dual EZH1/2 histone methyltransferase inhibitor, in combination with trastuzumab deruxtecan. Prior anti-HER2 therapy (including T-DXd and EZH inhibitors) is not allowed.

ClinicalTrials.gov ID: NCT05633979

A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

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.

HealthScout AI summary: This trial enrolls adults with select locally advanced or metastatic solid tumors—including hepatocellular, pancreatic, biliary tract, esophageal, breast, head and neck, and certain gynecologic cancers—who have measurable disease and adequate organ function. Patients receive intravenous ABBV-400, an antibody-drug conjugate targeting c-Met and delivering a topoisomerase 1 inhibitor, as monotherapy.

ClinicalTrials.gov ID: NCT06084481

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic HR+/HER2- breast cancer, squamous head and neck, urothelial, or endometrial cancers harboring PIK3CA mutations or amplifications, who have not previously received PI3K, AKT, or mTOR inhibitors. Patients receive TOS-358, a first-in-class, covalent, and selective PI3Kα inhibitor, administered orally as a single agent.

ClinicalTrials.gov ID: NCT05683418

TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY B (ARV-471 IN COMBINATION WITH RIBOCICLIB)

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.

HealthScout AI summary: Enrolling adults with ER+/HER2- advanced or metastatic breast cancer who have progressed on 1–2 prior lines of therapy (including a CDK4/6 inhibitor), this study investigates the combination of ARV-471, a novel oral PROTAC estrogen receptor degrader, with ribociclib. Patients must have measurable disease and good performance status, and key exclusions include life-threatening visceral crisis, significant lung or heart disease, untreated brain metastases, or active infections.

ClinicalTrials.gov ID: NCT05573555

A Phase I Study of In Situ Immunomodulation With CDX-301, Radiotherapy, CDX-1140, and Poly-ICLC in Patients With Unresectable and Metastatic Solid Tumors With Injectable Palpable Disease

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.

HealthScout AI summary: Adult patients with unresectable and metastatic melanoma, cutaneous SCC, BCC, Merkel cell carcinoma, high-grade sarcomas, or HER2-negative breast cancer with palpable, injectable lesions are eligible for this trial evaluating intratumoral CDX-301 (Flt3 ligand), radiotherapy, CDX-1140 (agonistic anti-CD40 antibody), and Poly-ICLC, with additional arms including pembrolizumab (PD-1 inhibitor) and tocilizumab (IL-6 receptor antagonist). The study focuses on safety and immunologic activity of this multi-agent in situ immunomodulation approach.

ClinicalTrials.gov ID: NCT04616248

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.

HealthScout AI summary: This trial is enrolling adults with advanced, unresectable, or metastatic solid tumors harboring PIK3CA (PI3Kα) mutations, including HR+ breast, gynecologic, endometrial, and head and neck cancers, to receive the investigational orally administered mutant-selective PI3Kα inhibitor STX-478 as monotherapy or in combination with standard endocrine and CDK4/6 inhibitors. Eligible patients must have ECOG 0-1 and adequate organ function; those with uncontrolled diabetes or symptomatic CNS metastases are excluded.

ClinicalTrials.gov ID: NCT05768139

A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Combination of CLBR001, an Engineered Autologous T Cell Product, and ABBV-461, an Antibody-Based Biologic, in Subjects With Locally Advanced or Metastatic 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.

HealthScout AI summary: This trial enrolls adults with refractory or relapsed locally advanced or metastatic breast cancer who have exhausted standard therapies, testing a novel regimen combining CLBR001, a universal switchable autologous CAR-T cell therapy, with ABBV-461, an adapter antibody that controls CAR-T activation and tumor targeting. Patients receive a single infusion of CLBR001 followed by cycles of ABBV-461 to evaluate safety, tolerability, and preliminary efficacy.

ClinicalTrials.gov ID: NCT06878248

Phase 2 Study of Zelenectide Pevedotin in Participants With NECTIN4 Amplified Advanced 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.

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.

No known activity

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

HealthScout AI summary: This trial enrolls adults with measurable, recurrent, unresectable, or metastatic NECTIN4-amplified breast cancer (either HR+/HER2-negative or triple-negative) who have received up to three prior lines of therapy. All participants receive zelenectide pevedotin (BT8009), a NECTIN4-targeting Bicycle Toxin Conjugate delivering MMAE.

ClinicalTrials.gov ID: NCT06840483

ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies

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.

HealthScout AI summary: This trial enrolls adults with either HER2-positive metastatic breast cancer that has progressed after prior therapy including T-DXd, or RAS/BRAF wild-type, pMMR/MSS metastatic colorectal cancer that has progressed after oxaliplatin-based first-line therapy, to receive the investigational CD47-blocking fusion protein evorpacept (which enhances macrophage-mediated phagocytosis) in combination with trastuzumab plus chemotherapy or with cetuximab and FOLFIRI, respectively. Candidates must have measurable disease, ECOG 0-1, and adequate organ function.

ClinicalTrials.gov ID: NCT07007559