A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
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A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer
High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer
A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
What is metastatic breast cancer?
Metastatic, or stage 4, breast cancer has spread beyond the breast and nearby lymph nodes to distant organs, most often the bones, liver, lungs, or brain. About 6 percent of people have metastatic disease when breast cancer is first found, called de novo; the rest develop it later as a recurrence, and an estimated 20 to 30 percent of early stage breast cancers eventually spread. Symptoms depend on where the cancer goes: bone pain, cough or breathlessness, abdominal discomfort, or headaches.
Treatment is chosen by subtype. Hormone receptor positive cancer is treated first with endocrine therapy and targeted drugs, HER2 positive cancer with HER2 directed medicines, and triple negative cancer with chemotherapy, immunotherapy, and antibody drug conjugates. In US data, about 3 in 10 people with distant disease are alive five years after diagnosis, with wide differences by subtype and steady improvement as new drugs arrive. Early stage disease is on our breast cancer clinical trials page.
Our breast cancer treatment guide explains the approved options by subtype.
Types of metastatic breast cancer clinical trials
Antibody drug conjugate trials. Chemotherapy carried by an antibody straight to the cancer cell, now tested against standard chemotherapy in Phase 3 for several subtypes.
Endocrine therapy trials. Oral SERDs and other drugs for hormone receptor positive cancer that has stopped responding, often chosen by ESR1 or PIK3CA mutations.
Biomarker matched trials. National programs that test the tumor and assign a targeted drug, including a National Cancer Institute study at hundreds of sites.
HER2 targeted trials. New HER2 drugs, including for HER2 low cancer and for spread to the brain.
Local therapy trials. Precise radiation or surgery to a few metastases in people with limited spread, called oligometastatic disease.
Quality of life studies. Bone health, symptom control, and support for people on treatment for many years.
Is metastatic breast cancer curable?
It is generally not curable, but it is increasingly treatable as a long term condition. Many people live for years through several lines of treatment, and new approvals have come faster for this stage than for any other in recent years.
Who can participate in metastatic breast cancer clinical trials?
Trials sort people by subtype and by how many treatments they have had. Most require hormone receptor and HER2 status from a biopsy, sometimes a mutation result such as ESR1 or PIK3CA, and progression after a set number of prior treatments, for example one or two endocrine based therapies. Many accept people with treated, stable brain metastases, and some are designed specifically for them. Adequate blood counts and organ function and the ability to manage daily activities are usual requirements, and men with metastatic breast cancer are eligible for most studies. Eligibility always varies by study.
Subtypes of metastatic breast cancer, and why they decide which trials fit
HR positive, HER2 negative. About 6 in 10 metastatic cases. Treated first with endocrine therapy plus a CDK4/6 inhibitor; trials test what comes after.
HER2 positive. Treated with HER2 directed antibodies and antibody drug conjugates; trials test new HER2 drugs and brain penetrating options.
HER2 low. HER2 negative cancers with some HER2 protein, now eligible for certain antibody drug conjugates and their trials.
Triple negative. No hormone receptors or HER2; see our TNBC page.
How to enroll in a metastatic breast cancer clinical trial
Identify your trial. Use the filters and match the subtype and line of treatment in the study title to your own history.
Select your preferred location. Enter your city or state. Phase 3 trials run at dozens of sites, including community oncology practices.
Explore study details. Click "Learn More" for biomarker requirements, prior treatment rules, brain metastasis rules, and the visit schedule.
Complete the health profile. Click "Get started" to begin the 5-step application. Have ready your hormone receptor and HER2 status, any tumor mutation results, and every treatment you have had in order.
Submit the application. A clinical trial coordinator reviews it and contacts you. Nothing is decided until informed consent, and participation is voluntary at every step.