METASTATIC BREAST CANCER

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) that no longer responds to standard hormone therapy or CDK4/6 inhibitors. About 65 participants will receiv…

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 study tests a new drug, palazestrant, combined with ribociclib against the standard letrozole and ribociclib for people with ER+, HER2- advanced breast cancer that has not been treated before. About 1000 adults with locally advanced or metastatic breast cancer will take part…

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 tests whether giving high-precision radiation (SBRT) to all visible tumor spots can delay cancer progression 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 or standard …

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 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 chemotherapy. The goal is to see if SKB264 can slow cancer growth better than standard treatments. About 376 adults aged 18-75 will …

This study compares two treatments for advanced estrogen receptor-positive (ER+) breast cancer that has stopped responding to standard therapies. About 297 participants will receive either a combination of two drugs (elacestrant and capecitabine) or capecitabine alone. The goal i…

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. About 150 adults will take pa…

This early-phase study tests an experimental oral drug called BBI-940 in people with advanced or metastatic breast cancer. The drug is given alone or with another medicine (fulvestrant). The main goals are to find a safe dose and check for side effects. About 96 adults with certa…

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 study tests whether giving a precise, high-dose radiation treatment (SBRT) to a single tumor that has started growing can help people with metastatic breast cancer stay stable longer. Participants continue their usual drug therapy while receiving SBRT. The goal is to see if …

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 study tests whether the drugs enzalutamide (alone or with mifepristone) can control advanced breast cancer that is androgen receptor-positive and triple-negative or estrogen receptor-low. About 201 adults with this type of cancer will be randomly assigned to one of the drug …

This study tests whether combining the immunotherapy drug pembrolizumab with precise radiation (SRS) can help control breast cancer that has spread to the brain. About 41 adults with at least two brain tumors will receive pembrolizumab every three weeks, plus radiation to one tum…

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 breast cancer. About 34 participants will …

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

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 study looks at whether a simple blood test can help doctors decide if a patient's breast cancer treatment is working early on. People with a certain type of advanced breast cancer (HR+ HER2-) will get standard first-line therapy. A blood test at day 15 will show if the treat…

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 fluid around the brain and spinal cord. The goal is to see if this treatment can help patients live longer. The trial includes adults with s…

This study tests a new drug called OP-1250 (palazestrant) against the usual treatments for a type of breast cancer that is hormone-receptor-positive and HER2-negative. It is for people whose cancer has grown or spread after initial hormone therapy combined with a CDK4/6 inhibitor…

This study tests a low 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 dose can still shrink tumors while causing fewer complications. Participants take one p…

This study tests whether adding belzutifan to fulvestrant can slow or stop the growth of a common type of advanced breast cancer (ER+/HER2-) that has worsened despite hormone therapy. About 120 adults will receive either the new combination or a standard treatment (everolimus plu…

This early-stage study tests a new drug called HLD-0117 in about 33 women with a type of advanced breast cancer (ER-positive) that has spread and stopped responding to standard treatments. The main goals are to check the drug's safety and find the right dose. Researchers will als…

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 experimental drugs, BNT323 and BNT327, together in people with advanced breast cancer that has spread or cannot be removed. The goal is to see if the combination can shrink tumors and control the disease. About 380 adults with specific HER2-positive, HER2-low…

This study tests a new combination of drugs (alpelisib, L-NMMA, and chemotherapy) in people with a rare and aggressive type of breast cancer called metaplastic breast cancer that has spread or cannot be removed by surgery. The goal is to see if the combination is safe and can shr…

This early-phase study tests a new drug called BBO-10203 in people with advanced solid tumors (breast, colorectal, or lung cancer) that have not responded to standard treatments. The drug works by blocking a key cancer growth signal (PI3Kα:RAS). The main goals are to find a safe …

This study is for people with ER-positive, HER2-negative metastatic breast cancer that has spread and cannot be removed by surgery. Researchers want to see if combining three drugs—lenvatinib, pembrolizumab, and fulvestrant—is safe and can shrink tumors. About 54 adults will take…

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 combination is safe and can reduce severe blood sugar spikes caused by the standard drugs. About 52 adults with specific …

This study tests a drug called alisertib combined with hormone therapy for people with a common type of advanced breast cancer (HR+, HER2-). The goal is to find the best dose and see if the combination can shrink tumors or slow the disease. About 150 adults whose cancer has worse…

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

This study tests whether adding surgery and targeted radiation to the usual treatment can help people with HER2+ breast cancer that has spread to a small number of spots (up to 5). About 178 adults will be randomly assigned to receive either standard care alone or standard care p…

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 study tests whether a new treatment called Bria-IMT, given with an immunotherapy drug (retifanlimab), helps people with advanced metastatic breast cancer live longer compared to standard chemotherapy. About 404 adults whose cancer has not responded to other treatments will t…

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 tests an experimental oral drug called PMD-026 in people with metastatic breast cancer (cancer that has spread). The drug targets a protein called RSK2 to kill cancer cells. The trial involves about 61 participants and aims to check the drug's safety and how well it wo…

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 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 HR+/HER2- breast cancer or other solid tumors that have spread. The main goal is to find the safest and most effective dose, either…

This study is for people with metastatic breast cancer whose disease has started to grow in just a few spots while on their current treatment. It tests whether using precise, high-dose radiation on those spots can allow them to keep using their current medication for at least 6 m…

This study tests a new drug, 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 or improve survival. Particip…

This study tests several new drug combinations containing FWD1802 in people with a common type of advanced breast cancer (ER-positive/HER2-negative) that cannot be removed by surgery or has spread. The study has two parts: first, finding the safest dose (Phase 1), and then checki…

This early-phase study tests a new drug called OP-3136 in people with advanced breast, lung, or prostate cancers that have stopped responding to standard treatments. The goal is to find a safe dose and see if the drug can shrink tumors or slow cancer growth. About 180 adults will…

This study tests a new drug called patritumab deruxtecan in people with advanced breast cancer that is hormone-receptor positive and no longer responds to hormone therapy or CDK4/6 inhibitors. About 99 participants will receive the drug every three weeks to see if it shrinks tumo…

This study tests an experimental drug called EP0062, alone or with standard treatments, in people with a certain type of advanced breast cancer (AR+/HER2-/ER+) that has come back or spread. The main goals are to find the safest dose and see if it helps shrink tumors. About 95 adu…

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 various breast cancer types wi…

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 compares the hormone therapy elacestrant alone versus elacestrant combined with a CDK4/6 inhibitor (palbociclib, abemaciclib, or ribociclib) in 174 people with ER+/HER2- advanced or metastatic breast cancer who have already used a CDK4/6 inhibitor. The goal is to see i…

This early-phase study tests the safety of combining two drugs, olaparib and estradiol, in post-menopausal women with advanced ER+/HER2- breast cancer that has spread. The goal is to find the best dose for future studies. Only 6 participants will be enrolled.

This study tests an experimental pill called zongertinib, which blocks HER2—a protein that makes cancer grow. It is for adults with advanced HER2+ breast, stomach, or colorectal cancer that has spread and hasn't responded to prior treatments. The study has two parts: first, findi…

This early-stage study tests a new drug, RLY-2608, designed to block a faulty protein in cancer cells with a specific gene change (PIK3CA mutation). It is for adults with advanced solid tumors or certain breast cancers that have not responded to other treatments. The study will t…

This study tests whether a gene test can help doctors pick the right chemotherapy for people with a certain type of advanced breast cancer (HR+ metastatic). About 64 adults whose cancer has stopped responding to hormone therapy will receive a chemo drug called capecitabine. The g…

This study compares two types of scans—FDG-PET/CT and standard CT—to see which one better tracks metastatic breast cancer. About 420 adults with newly diagnosed metastatic breast cancer will be randomly assigned to one scan type. The goal is to find out if the newer scan helps de…

This study tests a new type of PET scan that targets a protein called CXCR4, which is often found in high levels in triple-negative breast cancer. The goal is to see if this scan can find cancer spread as well as the standard scan. If successful, it could help doctors choose bett…

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 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 looks at whether a 12-week, home-based exercise program (aerobic and resistance training) can reduce cancer-related fatigue in people with metastatic breast cancer who are taking the drug Enhertu. About 80 adults who have already had 3 or 4 cycles of Enhertu will parti…

This study tests whether regular video or phone check-ins between patients with advanced breast cancer, their caregivers, and their oncology team can improve the hospice experience. About 200 participants will join from Massachusetts. The goal is to see if this approach is practi…

This pilot study tests whether a community navigator can help Black and Latina women with metastatic breast cancer access supportive services like symptom management and emotional support. About 67 women will be randomly assigned to receive the navigator program or usual care. Th…

This study tests a values assessment tool designed to help women with metastatic breast cancer and their caregivers talk more clearly with their doctors and feel less unsure about treatment choices. About 40 participants will use the tool and report on their communication and dec…

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 while reduci…

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 looks at whether a special cooling cap can help people with metastatic breast cancer keep more of their hair during chemotherapy. About 120 people will either use the Paxman Scalp Cooling System or not, and researchers will compare hair loss rates and quality of life. …

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 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 looks at how certain genetic changes (ESR1 mutations) 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 better understand why some cancers become resistant…

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 explores how certain genetic variations affect the risk of severe side effects from powerful breast cancer drugs called antibody-drug conjugates. Researchers will analyze the UGT1A1 gene in 70 patients with advanced breast cancer to see if specific variants lead to mor…

This study is looking for early warning signs of serious side effects from the breast cancer drug T-DXd. Researchers will collect blood samples from 84 people with advanced breast cancer before and during treatment. The goal is to find markers that could predict who is at risk fo…

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 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 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 is testing whether routine brain MRI scans can detect breast cancer that has spread to the brain in patients with certain types of advanced breast cancer. Researchers will follow 214 participants over time to see if early detection improves quality of life and reduces …

This study is looking for blood markers that could help predict where breast cancer might spread. Researchers will measure two types of markers in the blood of 160 women: some with cancer that has spread, some with early-stage cancer, and some healthy. The goal is to develop a no…

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…

This study follows 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 treatments control the cancer in real-world settings. The goal is to gather information…

This study enrolls 5,000 people with metastatic breast cancer to analyze their tumor and blood samples for genetic markers. The goal is to identify which patients might benefit from specific targeted therapies and connect them to appropriate clinical trials. Participants continue…

This study observes 2000 people with advanced breast cancer to learn how the disease changes over time and why some treatments stop working. Researchers collect tumor samples and health data to find new markers that predict treatment response. The goal is to improve future therap…