METASTATIC BREAST CANCER

This study tests whether adding surgery and targeted radiation to standard treatment can cure HER2-positive breast cancer that has spread to up to 5 spots in the body. About 178 adults with this condition will be randomly assigned to get either usual care alone or usual care plus…

This early-phase study tests a new drug called BGB-43395, which blocks a protein (CDK4) that helps cancer cells grow. It is for people with advanced hormone receptor-positive, HER2-negative breast cancer or other solid tumors that have spread. The study aims to find the safest an…

This study tests whether combining two drugs—elacestrant and trastuzumab deruxtecan—can shrink tumors in people with a certain type of advanced breast cancer (HR+, HER2-low or ultra-low) that has stopped responding to standard hormone therapy and CDK4/6 inhibitors. About 65 parti…

This study tests a new drug called OP-1250 (palazestrant) against standard treatments (fulvestrant or an aromatase inhibitor) in 510 people with a common type of advanced breast cancer (ER+, HER2-). Participants must have already tried hormone therapy plus a CDK4/6 inhibitor. The…

This early-phase trial tests the safety of an experimental oral drug called PMD-026 in people with metastatic breast cancer that has spread and cannot be cured. The drug targets a protein called RSK2 found on tumor cells. About 61 participants will receive the drug alone or with …

This phase 3 study tests whether adding capivasertib to standard hormone therapy helps people with HR+/HER2- advanced breast cancer stay on treatment longer and maintain quality of life. About 250 adults whose cancer worsened after prior hormone therapy will take capivasertib plu…

This study tests whether adding the immunotherapy drug pembrolizumab, with or without the targeted drug olaparib, to standard radiation therapy is safe and effective for people with metastatic triple-negative or hormone-receptor-positive/HER2-negative breast cancer. About 34 part…

This study is for people with a certain type of advanced breast cancer (ER+/HER2-). It tests the drug elacestrant together with other targeted therapies to see if these combinations are safe and can help control the cancer. About 435 adults will take part. The goal is to find the…

This study tests a new drug called SKB264 against standard chemotherapy in 430 people with advanced hormone receptor-positive, HER2-negative breast cancer that has stopped responding to hormone therapy. The goal is to see if SKB264 can delay cancer growth and improve survival. Pa…

This study tests whether giving high-precision radiation (SBRT) to all visible cancer spots can delay the disease from getting worse in people with 1 to 5 metastases from breast or lung cancer. About 145 participants will be randomly assigned to receive either standard care alone…

This study tests a new drug, palazestrant, combined with ribociclib against the standard letrozole with ribociclib for people with ER+, HER2- advanced breast cancer that has not been treated before. About 1,000 adults with locally advanced or metastatic breast cancer will take pa…

This study tests a new drug called EP0062 in people with advanced breast cancer that has come back after treatment. The goal is to find the best dose and see if it is safe and works, either alone or with other standard treatments. About 95 adults with a specific type of breast ca…

This study is for people with advanced breast cancer that is triple-negative or has low estrogen receptors and tests positive for androgen receptors. It compares two experimental treatments—enzalutamide alone or with mifepristone—against standard chemotherapy. The goal is to see …

This study tests a new drug called FWD1802 combined with other treatments for people with ER-positive/HER2-negative breast cancer that has spread or cannot be removed by surgery. About 196 participants will join to find safe doses and see if the combinations shrink tumors. The go…

This study tests an experimental drug called patritumab deruxtecan in people with advanced breast cancer that is hormone-receptor positive but no longer responds to hormone therapy or CDK4/6 inhibitors. About 139 participants will receive the drug every three weeks to see if it s…

This study tests a high dose of the chemotherapy drug methotrexate given through a vein in people with breast cancer that has spread to the lining of the brain. The goal is to see if it helps them live longer. The trial is for adults with certain types of breast cancer and is cur…

This study tests a lower daily dose of the chemotherapy drug capecitabine in 40 patients aged 60 or older, or those who are frail, with advanced breast cancer. The goal is to see if this gentler approach can still shrink tumors or slow the disease while being easier to tolerate. …

This study tests whether giving a precise, high-dose radiation treatment (SBRT) to a single spot where breast cancer has worsened can help keep the disease from spreading further. Participants continue their usual drug therapy while receiving SBRT. The goal is to see if this appr…

This study tests a new drug called SKB264 in people with a common type of advanced breast cancer (HR+/HER2-) that has not responded to at least one round of chemotherapy. About 376 participants will receive either SKB264 or a standard treatment chosen by their doctor. The goal is…

This study tests two experimental drugs (BNT323 and BNT327) together in people with advanced breast cancer that has spread or cannot be removed by surgery. The goal is to see if the combination can shrink tumors and control the disease. About 380 adults with various types of HER2…

This study tests a new drug called alisertib combined with hormone therapy for people with a common type of advanced breast cancer (HR+, HER2-). It is for those whose cancer has worsened after at least two prior hormone treatments. The goal is to find the best dose and see if the…

This early-phase study tests a new drug called HLD-0117 in about 33 women with a type of advanced breast cancer (ER-positive) that has spread or is locally advanced and has not responded to prior treatments. The main goals are to check the drug's safety and find the right dose. R…

This study tests whether adding belzutifan to fulvestrant works better than standard treatments for people with a common type of advanced breast cancer (ER+/HER2-) that has stopped responding to hormone therapy. About 120 adults will receive either the new combination or standard…

This early-stage study tests the safety of combining two drugs—olaparib and estradiol—in postmenopausal women with advanced ER+/HER2- breast cancer that has spread or come back. The goal is to find the best dose and see if the combination can help control the disease. Only 6 part…

This study looks at whether giving focused radiation to a few growing cancer spots can let patients with metastatic breast cancer stay on their current drug longer. About 45 adults whose cancer has started to progress after at least a year on first-line treatment will receive rad…

This study tests whether a gene test can help doctors pick the best second-line chemotherapy for people with a common type of advanced breast cancer (HR+ metastatic). About 64 participants will receive the drug capecitabine, and researchers will track how long their cancer stays …

This study tests whether combining lenvatinib, pembrolizumab, and fulvestrant is safe and works against ER-positive, HER2-negative breast cancer that has spread. About 54 adults with advanced disease will receive the drug combo. The goal is to find the best dose and see if tumors…

This study looks at whether a simple blood test can help doctors decide early on if a treatment is working for people with a certain type of advanced breast cancer (HR+ HER2-). About 65 participants will start standard therapy, and those whose blood test shows a poor response wil…

This early-phase study tests a new drug called BBO-10203 in about 392 adults with advanced solid tumors (like breast, lung, or colorectal cancer) that have not responded to other treatments. The drug works by blocking a key cancer growth pathway. The main goals are to find the sa…

This early-phase study tests an experimental oral drug called BBI-940 in people with advanced or metastatic breast cancer. The drug works by breaking down a protein that cancer cells need to grow. The study will find the safest dose and see if it works alone or with another drug.…

This early-stage study tests a new drug, RLY-2608, designed to target a specific genetic mutation (PIK3CA) found in some advanced solid tumors and breast cancers. The trial will enroll about 930 adults whose cancer has not responded to other treatments. Researchers aim to find th…

This early-phase trial tests a new treatment called p95HER2.CAR-TECH2Me for people with advanced HER2-positive cancers (breast, stomach, or endometrial cancer that has spread). The treatment uses a patient's own immune cells, which are modified in a lab to better recognize and at…

This early-phase trial tests whether freezing a tumor (cryoablation) can boost the immune system's response to the drug pembrolizumab in people with advanced triple-negative breast cancer. About 30 participants will either receive the combination or pembrolizumab alone. The goal …

This study tests several different drug combinations in people with metastatic breast cancer that has spread or cannot be removed by surgery. The goal is to see which combinations work best to shrink tumors or slow the disease. About 792 adults with specific breast cancer types w…

This study tests a new drug, evexomostat, added to two standard treatments for a common type of advanced breast cancer (HR+, HER2-). The goal is to see if the triple combination is safe and can reduce severe blood sugar spikes, a common side effect of current therapies. About 52 …

This study tests whether combining the drug pembrolizumab with precise radiation can help control breast cancer that has spread to the brain. About 41 adults with at least two brain tumors will receive the drug every three weeks and radiation to one tumor. The goal is to see if t…

This study tests if a new combination of two drugs (lasofoxifene and abemaciclib) works better than a standard combo (fulvestrant and abemaciclib) for people with advanced ER+/HER2- breast cancer that has a specific gene change called ESR1 mutation. About 500 adults whose cancer …

This early-stage study tests a new drug called BGB-21447, which blocks a protein that helps cancer cells survive. It is given together with standard hormone therapy (fulvestrant) and sometimes another targeted drug (BGB-43395) to adults with HR+/HER2- breast cancer that has sprea…

This study tests whether adding the drug inavolisib to standard maintenance therapy (Phesgo) can delay cancer progression in people with a specific genetic mutation (PIK3CA) and HER2-positive advanced breast cancer. About 230 participants who have already completed initial treatm…

This study tests a new way of giving approved drugs to people with hormone-positive metastatic breast cancer. The goal is to see if using the drugs in a specific order can better control the cancer and possibly lead to no evidence of disease. About 15 women who have already tried…

This study tests whether a new drug, RLY-2608, combined with fulvestrant works better than another drug combo (capivasertib + fulvestrant) for people with a specific genetic mutation (PIK3CA) in advanced hormone-receptor-positive, HER2-negative breast cancer. About 540 adults who…

This study follows about 1,155 adults with HER2-low breast cancer that has spread or cannot be removed by surgery. It compares how long patients stay on a new targeted drug (trastuzumab deruxtecan) versus standard chemotherapy before needing a different treatment. The goal is to …

This early-stage trial tests a new radioactive drug called [177Lu]Lu-ABY-271 in people with HER2-positive metastatic breast cancer that has spread and cannot be removed by surgery. The main goals are to check safety and see where the drug travels in the body. About 21 participant…

This study is for people with a common type of advanced breast cancer (ER+/HER2-) that has stopped responding to a previous targeted treatment. It compares taking the hormone drug elacestrant alone versus combining it with another targeted drug (palbociclib, abemaciclib, or riboc…

This study tests a new treatment called Bria-IMT combined with an immunotherapy drug (retifanlimab) for people with advanced metastatic breast cancer who have run out of standard options. About 404 participants will be randomly assigned to receive either this new combination or a…

This study tests a three-drug combination (alpelisib, L-NMMA, and chemotherapy) in people with a rare, aggressive type of breast cancer called metaplastic breast cancer that has spread or is locally advanced and hasn't responded to prior treatments. The goal is to see if adding t…

This study tests an experimental drug called SHR-A1811 in people with advanced breast cancer that has spread to the brain. The cancer must have a protein called HER2 (either high or low levels). The goal is to see if the drug can shrink brain tumors and control the disease. About…

This study tests whether adding elacestrant to standard chemotherapy (capecitabine) can help people with advanced estrogen receptor-positive (ER+) breast cancer that no longer responds to CDK 4/6 inhibitors. About 297 participants will be randomly assigned to get either the combi…

This early-phase study tests a new drug called OP-3136 in adults with advanced breast, lung, or prostate cancer that has spread or no longer responds to standard treatments. The goal is to find a safe dose and see if the drug, alone or with other cancer medicines, can shrink tumo…

This study tests an experimental oral drug called zongertinib, which blocks HER2 (a protein that fuels cancer growth). It is given alone or with other standard treatments to adults with advanced HER2+ breast, stomach, or colorectal cancer that has spread and no longer responds to…

This study tests different doses of the drug abemaciclib given together with radiation therapy for people with advanced hormone receptor-positive, HER2-negative breast cancer that has spread to the bone. The goal is to find the safest dose of abemaciclib when used alongside stand…

This phase 3 trial tests a new drug called HRS-8080 against standard treatments chosen by doctors for women with advanced breast cancer that has worsened after hormone therapy. About 240 women aged 18-75 will be randomly assigned to receive either HRS-8080 or another treatment. T…

This early-phase study tests a new drug called IPH5301 in people with advanced solid tumors that have spread. The drug aims to block a protein (CD73) that helps tumors hide from the immune system. The trial first finds the safest dose alone, then tests it with chemotherapy and an…

This study tests whether adding the drug tocilizumab (used for arthritis) to standard chemotherapy helps shrink tumors or delay cancer growth in people with metastatic triple-negative or estrogen-receptor-low breast cancer. The trial enrolls 168 Black and non-Black adults who hav…

This study is for people with breast cancer that has spread to only a few spots in the body (oligometastasis). It tests whether adding focused treatments like radiation or surgery to standard drug therapy can help people live longer. About 340 participants will first receive 12 w…

This study tests a new drug called FWD1802 in people with a specific type of advanced breast cancer (ER+/HER2-). The goal is to find a safe dose and see if it can shrink tumors. About 99 women with cancer that has spread or cannot be removed by surgery will take part.

This study tests a combination of three drugs (anastrozole, fulvestrant, and abemaciclib) in 20 people with a common type of advanced breast cancer (HR-positive, HER2-negative). The goal is to see how well the treatment shrinks or controls the cancer. Participants either have new…

This study tests a new drug called OP-1250 (Palazestrant) combined with other targeted therapies in people with advanced or metastatic ER-positive, HER2-negative breast cancer. About 190 adults will receive one of four drug combinations to find the safest dose and understand side…

This early-phase study tests two drugs, palbociclib and avelumab, together for people with a specific type of advanced breast cancer (AR+ triple-negative). The main goals are to find the safest doses and see if the combination can shrink tumors. About 45 participants with advance…

This study tests two antibody drug conjugates (datopotamab deruxtecan and trastuzumab deruxtecan) given one after the other in people with HER2-negative metastatic breast cancer that has worsened after prior treatment. The goal is to see if this sequence can shrink tumors or slow…

This early-stage study tests a new drug called ERX-315 in people with advanced solid tumors (like breast, ovarian, or pancreatic cancer) that no longer respond to standard treatments. The main goal is to check the drug's safety and find the best dose for future studies. About 15 …

This study tests a new way of giving the chemotherapy drug capecitabine to people with metastatic ER-positive, HER2-negative breast cancer. Instead of a fixed dose, the dose is adjusted based on how the tumor responds on scans and blood tests. The goal is to better control the ca…

This study is for people with metastatic breast cancer (cancer that has spread). It aims to see if choosing treatments based on specific tumor markers (biomarkers) can help control the disease longer. About 700 participants will receive standard therapies matched to their biomark…

This study tests a combination of two drugs—disitamab vedotin and tucatinib—for people with advanced breast or stomach cancers that have a protein called HER2. The goal is to see if the combo is safe and can shrink or control tumors. About 172 adults with these cancers who have a…

This study tests if a form of estrogen (estradiol) can help control advanced breast cancer that is hormone-receptor-positive (ER+). It includes 36 post-menopausal women whose cancer has spread or returned and who have already tried other hormone therapies. The goal is to see if w…

This study looks at whether giving antibody-drug conjugates (ADCs) a second time is safe and effective for people with advanced breast cancer that has spread. About 160 adults who have already received ADCs will be enrolled. The goal is to see if the tumors shrink or stop growing…

This study looks at how well the drug inavolisib works for people with a certain type of advanced breast cancer that has stopped responding to hormone therapy. The cancer must have a specific gene change (PIK3CA mutation) and be hormone receptor-positive and HER2-negative. About …

This study tests whether the drug sacituzumab govitecan (SG) can still shrink tumors in people with a certain type of advanced breast cancer (HR+/HER2 low) who have already received a similar drug called T-DXd. About 75 adults will receive SG at its standard dose. The goal is to …

This study tests a new type of PET scan to see if it can better detect where triple-negative breast cancer has spread in the body. Researchers will compare this new scan to the standard one in 12 patients. If successful, it could help doctors choose more personalized treatments.

This study compares two types of PET scans to see which is better at finding and tracking metastatic lobular breast cancer. About 30 adults with this cancer will receive both an experimental FES PET/CT scan and a standard FDG PET/CT scan. The goal is to improve detection and moni…

This study looks at whether taking endocrine therapy in the morning or evening makes a difference for people with metastatic breast or prostate cancer. About 50 participants will be randomly assigned to take their medication at one of these times. The main goal is to see if a lar…

This study looks at whether a community-based exercise program called Get Real and Heel can help people with metastatic breast cancer become more physically active. Researchers want to see if the program improves quality of life, physical function, and social support. About 50 pa…

This pilot study will test whether a community navigator can help Black and Latina women with metastatic breast cancer access supportive services like palliative care. About 67 women will be assigned to work with a navigator or receive usual care. The goal is to see if the progra…

This study tests if a special cooling cap can reduce hair loss in people with metastatic breast cancer who are receiving certain chemotherapy drugs. About 120 participants will either use the Paxman Scalp Cooling System or not, and researchers will compare hair loss rates and qua…

This study looks at whether a 12-week, home-based exercise program (a mix of aerobic and resistance training) can help reduce cancer-related fatigue in people with metastatic breast cancer who are taking the drug Enhertu. About 80 adults who have already started Enhertu will part…

This study tests a remote stress-management program called PRISM for people recently diagnosed with metastatic breast cancer. The goal is to see if it improves resilience, quality of life, and possibly survival, especially for Black women who often face worse outcomes. About 120 …

This study tests a five-session palliative care program designed for people with metastatic breast cancer and their caregivers. The goal is to help patients talk with their doctors about what matters most to them, while also managing symptoms. Researchers will enroll 400 particip…

This study tests if a special PET/CT scan can detect cancer progression earlier than standard CT scans in people with metastatic breast cancer. About 420 adults starting their first treatment will be randomly assigned to one scan type. The goal is to see if earlier detection lead…

This study is testing whether a simple blood test can help predict where breast cancer might spread in the body. Researchers will measure two types of markers in the blood: PTEN (a protein that normally stops tumors) and microRNAs (tiny molecules that can signal cancer activity).…

This study is testing a values assessment tool for women with metastatic breast cancer and their caregivers. The goal is to see if using the tool helps patients and caregivers feel less conflicted about decisions and improves communication with their cancer doctors. About 40 peop…

This study is tracking 100 people with HER2-negative metastatic breast cancer who are receiving antibody-drug conjugates (ADCs) as part of their normal care. Researchers want to see how long these drugs control the cancer in real-world settings. The goal is to gather information …

This study explores whether genetic differences in the UGT1A1 gene can predict severe side effects from certain breast cancer drugs (antibody-drug conjugates). Researchers will enroll 70 adults with advanced breast cancer who are starting treatment with sacituzumab-govitecan, tra…

This study looks at how differences in HER2 levels and location across tumors impact the effectiveness of the drug trastuzumab deruxtecan in people with metastatic breast cancer. Researchers will follow 800 participants to see if these variations affect how long the cancer stays …

This study looks at whether routine brain MRIs can find cancer that has spread to the brain in people with metastatic or inflammatory breast cancer. About 214 participants will get screening MRIs to see how often brain metastases occur and how they affect quality of life. The goa…

This study aims to improve treatment for metastatic breast cancer by analyzing the genetic makeup of tumors. Researchers will collect tissue and blood samples from 5,000 participants to identify specific biomarkers and drug targets. The goal is to match patients with the most pro…

This study is observing 2,000 people with metastatic breast cancer to learn how the disease changes over time and why some treatments stop working. Researchers will analyze tumor samples and track patient outcomes to develop better ways to predict and treat the cancer. No new tre…

This study looks at whether starting with a lower dose of CDK4/6 inhibitor pills (palbociclib or ribociclib) and slowly increasing the dose helps older adults (65+) with metastatic breast cancer tolerate side effects better and stay on treatment longer. About 500 participants wil…

This study looks at whether emotional distress (like anxiety or depression) impacts how well first-line therapy works in people with metastatic breast cancer. Researchers will follow 1000 patients starting standard treatment and track their cancer progression over time. The goal …

This study is for people with advanced breast cancer who are about to start treatment with the drug T-DXd. The goal is to find markers in the blood that could predict serious side effects, like lung inflammation. By collecting blood samples before and during treatment, researcher…

This study explores how regular video or phone check-ins between patients with advanced breast cancer, their caregivers, and their oncology team can improve the hospice experience at home. Researchers will enroll 200 participants in Massachusetts to see if this approach is practi…

This study looks at how certain gene mutations (ESR1 and others) appear in the blood of people with metastatic breast cancer. Researchers will compare patients who have had prior treatments with those who haven't. The goal is to understand how these mutations develop, which may h…

This study is testing a blood test called DiviTum TKa to see if it can predict when hormone-receptor-positive (HR+) metastatic breast cancer stops responding to treatment. About 100 people starting standard therapies (endocrine therapy with or without a CDK4/6 inhibitor) will giv…

This study looks at whether a protein called PSMA, usually found in prostate cancer, is present in a certain type of advanced breast cancer (HER2-negative, AR-positive). Researchers will use a special PET/CT scan to measure PSMA levels in up to 15 participants. The goal is to see…

This study is building a registry of people with metastatic lobular breast cancer, a less common type of breast cancer. Researchers will collect data from about 12 participants to create a new tool that better measures how well treatments are working. The goal is to improve survi…

This study is for people with advanced breast cancer whose current treatment has stopped working. Researchers will take a small sample of the tumor and grow it in the lab to create a 'tumorogram'—a test that shows which drugs might work best. Based on the results, doctors will ch…

This study aims to create a detailed map of the tiny structures inside breast cancer cells, such as fat droplets and other organelles, across different cancer subtypes. Researchers will collect tissue samples from 1,050 people with early or metastatic breast cancer and analyze th…

This study interviews 15 doctors and nurses who care for people with metastatic breast cancer. The goal is to find out if a new computer tool that predicts how the disease may progress is easy to use and helpful. The results will guide how to best bring this tool into everyday ca…

This study looks at whether it is possible and acceptable to take multiple tissue samples (biopsies) from different tumor sites over time in people with metastatic breast cancer. The goal is to understand how the cancer changes and becomes resistant to treatment. Researchers will…