Condition

HER2-negative Breast Cancer clinical trials and research

• 59Clinical trials
• 1NIH research projects
• 1New in 30 days
• 36Countries

Newest HER2-negative Breast Cancer clinical trials

All recruiting trials (59)

• PRT13722 in advanced HR+/HER2- breast cancer

  This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.

  Recruiting Phase 1 Prelude Therapeutics Incorporated · Maumee, Ohio · NCT07905001

• Giredestrant in ER-positive, HER2-negative early breast cancer: who tolerates it and sticks with treatment

  This study tests how well people with ER-positive, HER2-negative early breast cancer can tolerate and stay on giredestrant, and how they feel during treatment.

  Recruiting Phase 3 Hoffmann-La Roche · Québec, Quebec · NCT07827573

• Metronomic Oral Paclitaxel for Advanced HER2-Negative Breast Cancer

  This study tests whether low, regular doses of an oral paclitaxel solution can be safely used to control tumor growth in adults with advanced HER2-negative breast cancer who have already had prior cancer therapy.

  Recruiting Phase 2 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT07602907

• RGT-490 for adults with PIK3CA-mutated advanced solid tumors

  This trial will test RGT-490, an oral medicine, in adults whose advanced solid tumors carry a PIK3CA mutation and have progressed after prior therapy.

  Recruiting at 6 sites Phase 1 Regor Pharmaceuticals Inc. · Los Angeles, California and 5 other locations · NCT07524322

• Pre-surgery hormone therapy to lower positive margins in lobular breast cancer

  This Phase 2 trial tests whether giving endocrine (hormone) therapy before breast-conserving surgery can reduce the chance of cancer at the edges of the removed tissue in postmenopausal people with ER+/HER2- invasive lobular breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07483307

• Radiation with anlotinib for HER2-negative breast cancer brain metastases

  This trial tests whether adding the drug anlotinib to stereotactic or whole-brain radiotherapy (with a microtubule inhibitor) helps people with HER2-negative breast cancer that has spread to the brain.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing · NCT07396454

• Real-world use of EndoPredict to guide treatment in early HR+/HER2- breast cancer

  This tests whether the EndoPredict genomic test can predict 10-year relapse risk and help decide if people with early HR+/HER2- breast cancer need chemotherapy in addition to hormone therapy.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07379918

• CDK4/6 inhibitors with endocrine therapy before surgery for HR+/HER2- high-risk early breast cancer

  This study tests whether adding a CDK4/6 inhibitor to endocrine therapy before surgery can help guide safer de-escalation of chemotherapy using ctDNA as a marker.

  Recruiting Phase 2 Peking University People's Hospital · Beijing, Beijing Municipality · NCT07366112

• Capivasertib plus endocrine therapy for HR+/HER2- advanced breast cancer after progression on endocrine treatment

  This trial will test whether adding capivasertib to standard endocrine therapy helps adults with HR+/HER2- advanced or metastatic breast cancer who progressed on prior endocrine treatment stay on treatment longer and maintain quality of life.

  Recruiting at 15 sites Phase 3 Women's Cancer Study Group GmbH · Anderlecht and 15 other locations · NCT07281833

• TheraBionic P1 device in advanced HR-positive, HER2-negative breast cancer

  This trial tests whether the TheraBionic P1 device can help women with advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed on standard therapies, by looking at survival and disease control.

  Recruiting at 8 sites Barbara Ann Karmanos Cancer Institute · Bay City, Michigan and 7 other locations · NCT07227831

• Adding TheraBionic P1 radiofrequency therapy to treatment for early-stage HR+ HER2- breast cancer

  This study will try giving TheraBionic P1 amplitude-modulated radiofrequency therapy before surgery to see if it improves tumor response in women with early-stage, hormone receptor–positive, HER2-negative breast cancer.

  Recruiting at 8 sites Barbara Ann Karmanos Cancer Institute · Clarkston, Michigan and 7 other locations · NCT07218432

• Elacestrant plus trastuzumab deruxtecan for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after CDK4/6 and endocrine therapy

  This trial tests whether combining elacestrant with trastuzumab deruxtecan helps people with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer that progressed after CDK4/6 inhibitor and endocrine treatment.

  Recruiting Phase 1/2 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07198724

• DR-0202 for advanced, relapsed, or treatment-resistant carcinomas

  This trial tests DR-0202 in adults with advanced or metastatic carcinomas—such as certain breast, lung, cervical, and prostate cancers—that have relapsed or stopped responding to standard treatments.

  Recruiting at 10 sites Phase 1 Dren Bio · Denver, Colorado and 9 other locations · NCT06999187

• Real-world look at SKB264 in HER2-negative breast cancer that has come back or spread

  This real-world study tests sacituzumab tirumotecan (SKB264) alone or with others in adults with recurrent or metastatic HER2-negative breast cancer.

  Recruiting at 12 sites Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Hefei, Anhui and 18 other locations · NCT06993506

• RLY-2608 plus fulvestrant versus capivasertib plus fulvestrant for PIK3CA‑mutant HR+/HER2‑ advanced breast cancer

  This trial tests whether RLY-2608 combined with fulvestrant works better than capivasertib combined with fulvestrant for adults with HR+/HER2‑ advanced breast cancer that has a PIK3CA mutation and progressed after a CDK4/6 inhibitor.

  Recruiting at 254 sites Phase 3 Relay Therapeutics, Inc. · Gilbert, Arizona and 253 other locations · NCT06982521

• ctDNA-guided reduction of chemotherapy using dalpiciclib plus endocrine therapy in high-risk HR+/HER2- early breast cancer

  This trial tests whether giving the CDK4/6 drug dalpiciclib with endocrine therapy and using ctDNA results can let some women with early high-risk HR+/HER2- breast cancer skip or reduce chemotherapy.

  Recruiting Phase 2 Peking University People's Hospital · Beijing, Beijing Municipality · NCT06970912

• Skipping chemotherapy for certain ER-positive, HER2-negative, node-positive breast cancers while using ribociclib with hormone therapy

  This trial tests whether skipping adjuvant chemotherapy and treating with ribociclib plus hormone therapy helps people with ER-positive, HER2-negative, node-positive breast cancer and a low Oncotype DX score stay on their CDK4/6 treatment.

  Recruiting Phase 2 Yale University · New Haven, Connecticut · NCT06953882

• Re‑irradiating the breast after a second lumpectomy

  This trial will test whether targeted re‑irradiation (IMRT) after a second lumpectomy is safe for people with ER+ / HER2‑ breast cancer who previously received breast radiation.

  Recruiting at 2 sites Baptist Health South Florida · Boca Raton, Florida and 1 other locations · NCT06867484

• Antibody-drug conjugates for first- and second-line treatment of metastatic HER2‑negative and triple‑negative breast cancer

  This prospective registry will collect real-world data to see how FDA-approved antibody-drug conjugates work as first- or second-line treatments for adults with metastatic HER2‑negative or triple-negative breast cancer.

  Recruiting at 3 sites University of California, San Francisco · San Francisco, California and 2 other locations · NCT06774027

• Testing a new combination of drugs for advanced breast cancer

  This study is testing a new combination of drugs to see if they can help adults with advanced breast cancer that hasn't responded to previous treatments.

  Recruiting at 13 sites Phase 1 BeOne Medicines · Iowa City, Iowa and 13 other locations · NCT06756932

• Treatment for HER2-negative breast cancer that is resistant to immune therapy

  This study is testing a new treatment combining retinoic acid with immune therapy and chemotherapy to see if it helps people with advanced HER2-negative breast cancer that hasn't improved with previous treatments.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT06731140

• Testing Abemaciclib with Radiation Therapy for Metastatic Breast Cancer

  This study is testing different doses of the drug abemaciclib in people with metastatic breast cancer who are also getting hormone therapy and radiation to see if it helps them better manage their symptoms.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT06678269

• How well patients stick to aromatase inhibitor treatment, with or without abemaciclib, for early HR+/HER2- breast cancer

  This study tests whether people with early HR+/HER2- breast cancer stick to aromatase inhibitor treatment more or less when they also take abemaciclib.

  Recruiting Institute of Oncology Ljubljana · Ljubljana · NCT06650423

• Testing new antibody drugs in advanced breast cancer patients who have used similar treatments before

  This study is testing new antibody drugs to see if they can help advanced breast cancer patients who have already tried similar treatments.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT06649331

• Treatment for advanced breast cancer using RYZ101

  This study is testing a new treatment called RYZ101 for people with advanced breast cancer that can't be removed by surgery to see if it helps manage their condition.

  Recruiting Phase 1/2 RayzeBio, Inc. · Phoenix, Arizona and 30 other locations · NCT06590857

• Treatment for HER2-negative metastatic breast cancer using two investigational drugs

  This study is testing if using two new drugs one after the other can help people with HER2-negative metastatic breast cancer live longer and feel better.

  Recruiting at 10 sites Phase 2 Dana-Farber Cancer Institute · Birmingham, Alabama and 10 other locations · NCT06533826

• Using tirzepatide to help with weight loss in early-stage breast cancer patients

  This study is testing if the medication tirzepatide can help women with early-stage breast cancer lose at least 5% of their body weight while they receive treatment.

  Recruiting at 6 sites Phase 2 Rutgers, The State University of New Jersey · Elizabeth, New Jersey and 6 other locations · NCT06518837

• Neoadjuvant treatment for gBRCA-mutated HER2-negative breast cancer

  This study is testing a new treatment combination for women with a specific type of breast cancer linked to BRCA mutations to see if it can work without traditional chemotherapy.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT06516289

• Testing axatilimab with olaparib for advanced HER2-negative breast cancer with specific gene mutations

  This study is testing a new drug called axatilimab combined with olaparib to see if it helps people with advanced HER2-negative breast cancer who have specific gene mutations.

  Recruiting at 2 sites Phase 1 Dana-Farber Cancer Institute · Boston, Massachusetts and 1 other locations · NCT06488378

• Measuring a biomarker for breast cancer treatment effectiveness

  This study is testing if measuring a specific biomarker can help doctors understand how well hormone treatments are working for people with advanced breast cancer.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT06388122

• Combination treatment for advanced ER-positive breast cancer with ESR1 mutations

  This study is testing if a new combination of two drugs can help people with advanced ER-positive breast cancer that has specific mutations live longer and keep their cancer under control.

  Recruiting at 81 sites Phase 3 MedSIR · Innsbruck and 103 other locations · NCT06382948

• Breast conserving surgery with intraoperative radiotherapy for early breast cancer

  This study is testing whether a new type of radiation given during breast-conserving surgery can help early breast cancer patients have fewer complications and better results compared to the standard radiation treatment.

  Recruiting Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT06375798

• Intrathecal chemotherapy for HER2-negative breast cancer with leptomeningeal metastasis

  This study is testing whether a special type of chemotherapy delivered directly to the spinal fluid can help people with HER2-negative breast cancer that has spread to the brain's protective layers feel better compared to just using regular chemotherapy.

  Recruiting Phase 4 Fudan University · Shanghai, Shanghai Municipality · NCT06230055

• Datopotamab deruxtecan for treating breast cancer that has spread to the brain

  This study is testing a new drug called datopotamab deruxtecan to see if it can help people with HER2-negative breast cancer that has spread to the brain.

  Recruiting at 3 sites Phase 2 Dana-Farber Cancer Institute · Miami, Florida and 2 other locations · NCT06176261

• BGB-43395 treatment for advanced breast cancer and other solid tumors

  This study is testing a new treatment called BGB-43395 for people with advanced breast cancer and other solid tumors to see if it works better alone or with other medications.

  Recruiting at 57 sites Phase 1 BeOne Medicines · Denver, Colorado and 60 other locations · NCT06120283

• Personalized treatment for advanced HER2-negative breast cancer using organoids

  This study is testing whether using personalized treatment based on lab-grown samples of a patient's tumor can help people with advanced HER2-negative breast cancer feel better compared to standard treatment chosen by their doctor.

  Recruiting Phase 2 Guangdong Provincial People's Hospital · Guangzhou, Guangdong · NCT06102824

• Evaluating Dapagliflozin with Neoadjuvant Therapy for HER2-negative Breast Cancer

  This study is testing if adding the diabetes medication dapagliflozin to standard treatment can help women with early-stage HER2-negative breast cancer feel better and improve their treatment results.

  Recruiting Phase 1 Yale University · New Haven, Connecticut · NCT05989347

• Elacestrant alone or with triptorelin for premenopausal luminal (HR+/HER2−) breast cancer

  This trial will test whether the oral drug elacestrant, given alone or with triptorelin (and compared to tamoxifen in Part B), changes tumor biology in premenopausal women with operable hormone receptor–positive, HER2‑negative breast cancer.

  Recruiting at 15 sites Phase 2 SOLTI Breast Cancer Research Group · Badalona, Barcelona and 14 other locations · NCT05982093

• Platform program for evaluating treatments in metastatic HER2-positive breast cancer

  This study is testing different new treatments for people with advanced HER2-positive breast cancer to see which ones work best before moving them to larger trials.

  Recruiting at 5 sites Phase 1/2 QuantumLeap Healthcare Collaborative · Birmingham, Alabama and 9 other locations · NCT05868226

• Evaluating GI-102 for advanced solid tumors with or without other cancer drugs

  This study is testing a new cancer treatment called GI-102, both on its own and with other cancer drugs, to see how safe it is and how well it works for people with advanced solid tumors.

  Recruiting at 11 sites Phase 1/2 GI Innovation, Inc. · Scottsdale, Arizona and 10 other locations · NCT05824975

• Combining alpelisib with chemotherapy for HER2 negative metaplastic breast cancer

  This study is testing whether combining a new drug called alpelisib with chemotherapy can help people with a rare and tough type of breast cancer feel better and improve their treatment results.

  Recruiting at 3 sites Phase 2 The Methodist Hospital Research Institute · Bethesda, Maryland and 2 other locations · NCT05660083

• Precision therapy for advanced breast cancer patients

  This study is testing different targeted treatments for patients with advanced breast cancer who have already tried certain medications, to see if personalized options can help them feel better.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT05594095

• Precision neoadjuvant therapy for operable breast cancer

  This study is testing if a personalized treatment approach using new drugs for operable breast cancer can work better than standard chemotherapy alone.

  Recruiting Phase 2 Fudan University · Shanghai, Shanghai Municipality · NCT05582499

• Combination therapy for hormone receptor-positive metastatic breast cancer

  This study is testing a new combination of three medications to see if it can help people who have just been diagnosed with advanced hormone receptor-positive breast cancer or those who have had a relapse after being cancer-free for over a year.

  Recruiting Phase 2 University of California, Irvine · Orange, California · NCT05524584

• Using elacestrant to treat ER+/HER2- breast cancer patients with ctDNA relapse

  This study is testing if a new drug called elacestrant can help women with ER-positive, HER2-negative breast cancer who have had a relapse, compared to their usual treatment.

  Recruiting at 113 sites Phase 3 European Organisation for Research and Treatment of Cancer - EORTC · Anderlecht and 112 other locations · NCT05512364

• DC1 dendritic-cell vaccine with chemotherapy for early-stage triple-negative and ER-low breast cancer

  This trial will test whether a dendritic cell vaccine given with standard chemotherapy helps people with early-stage triple-negative or ER-low breast cancer.

  Recruiting Phase 1 H. Lee Moffitt Cancer Center and Research Institute · Tampa, Florida · NCT05504707

• Ribociclib and hormone therapy for recurrent breast cancer

  This study is testing if a new drug called ribociclib, when combined with hormone therapy, can help people with recurrent hormone receptor-positive breast cancer feel better and manage their condition.

  Recruiting at 19 sites Phase 2 Hoosier Cancer Research Network · Birmingham, Alabama and 20 other locations · NCT05467891

• Examining the immune environment in different types of breast cancer

  This study looks at tissue samples from women with different types of breast cancer to see how the immune environment affects treatment responses.

  Recruiting Abramson Cancer Center at Penn Medicine · Philadelphia, Pennsylvania · NCT05396612

• Ovarian function suppression for premenopausal women with low-risk breast cancer

  This study is testing if lowering ovarian function with hormone treatments can help premenopausal women with low-risk breast cancer after surgery feel better and avoid chemotherapy.

  Recruiting Phase 4 Gangnam Severance Hospital · Seoul, Korea and 1 other locations · NCT05333328

• Combination treatment for advanced breast cancer

  This study is testing if a new combination of two drugs can help women with advanced breast cancer who haven't responded to previous treatments.

  Recruiting Phase 2 The Methodist Hospital Research Institute · Houston, Texas · NCT05305924

• Testing a new drug for advanced solid tumors and breast cancer with specific mutations

  This study is testing a new drug called RLY-2608 to see if it can help people with advanced solid tumors and breast cancer that have specific mutations.

  Recruiting at 36 sites Phase 1 Relay Therapeutics, Inc. · Tucson, Arizona and 36 other locations · NCT05216432

• Combination of immunotherapy and chemotherapy for HER2-negative breast cancer

  This study is testing if combining two immunotherapy drugs with standard chemotherapy can help people with advanced HER2-negative breast cancer feel better and live longer.

  Recruiting at 5 sites Phase 1 University of Texas Southwestern Medical Center · Chicago, Illinois and 6 other locations · NCT05029999

• Detecting and treating early breast cancer relapse using ctDNA analysis

  This study is testing if checking for cancer DNA in the blood can help catch early breast cancer relapses in women with a specific type of breast cancer and see if treating those at risk with a new combination of medications can improve their chances of staying cancer-free.

  Recruiting at 42 sites Phase 2 Royal Marsden NHS Foundation Trust · Angers and 48 other locations · NCT04985266

• Identifying resistance to CDK4/6 inhibitors in breast cancer

  This study is trying to find out why some women with a specific type of advanced breast cancer don't respond to a common treatment that includes a CDK4/6 inhibitor and an aromatase inhibitor by collecting and analyzing their blood and tissue samples during treatment.

  Recruiting Fondazione Sandro Pitigliani · Prato, Tuscany · NCT04660435

• Evaluating PC14586 for advanced solid tumors with a specific mutation

  This study is testing a new oral medication called PC14586 to see if it can help people with advanced solid tumors that have a specific mutation in the TP53 gene.

  Recruiting at 71 sites Phase 1/2 PMV Pharmaceuticals, Inc · Irvine, California and 75 other locations · NCT04585750

• Evaluating a new chemotherapy regimen for HER2-negative breast cancer before surgery

  This study is testing a new type of chemotherapy to see if it works better than standard treatment for women with HER2-negative breast cancer before they have surgery.

  Recruiting Phase 2/3 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT04576143

• Evaluating sacituzumab govitecan for localized triple negative breast cancer

  This study is testing a new drug called sacituzumab govitecan for people with localized triple negative breast cancer to see if it can help them.

  Recruiting at 4 sites Phase 2 Massachusetts General Hospital · Boston, Massachusetts and 4 other locations · NCT04230109

• Treatment for metastatic cancer with BRCA or PALB2 mutations using chemotherapy and stem cells

  This study is testing a new treatment combining chemotherapy and stem cells for people with metastatic pancreatic or breast cancer who have BRCA or PALB2 mutations to see if it is safe and effective.

  Recruiting Phase 1 General Oncology, Inc. · Boston, Massachusetts and 1 other locations · NCT04150042

• Personalized treatment for breast cancer using new drug agents

  This study is testing new drug combinations with standard chemotherapy to see which treatments work best for different types of breast cancer based on the specific characteristics of each patient's tumor.

  Recruiting at 32 sites Phase 2 QuantumLeap Healthcare Collaborative · Birmingham, Alabama and 41 other locations · NCT01042379

NIH-funded research (1)

Early-stage science funded by the US National Institutes of Health. Most of these projects don't enroll patients, but they show what is being worked on.

• Targeting CDK2 to treat hormone receptor–positive, HER2-negative breast cancer that has stopped responding to CDK4/6 inhibitors

  A study at a major hospital is testing CDK2 inhibitors to help patients with HR+/HER2− breast cancer whose cancer has become resistant to CDK4/6 inhibitors.

  NIH research Massachusetts General Hospital · Boston, United States · NIH-11427743

Related topics

Quick answers

How many HER2-negative Breast Cancer clinical trials are recruiting right now?

59, as of November 12, 2026. 1 of them was first registered in the last 30 days. We update this list each time we refresh our data from ClinicalTrials.gov.

Where are these trials running?

In 36 countries. The most sites are in United States (35 trials), China (16 trials), France (8 trials), South Korea (6 trials), Italy (6 trials). Each study page lists its sites and which ones are recruiting.

What phases are they in?

Phase 2: 23, Phase 1: 12, Phase 1/2: 5, Phase 3: 5. Trials with no phase listed are usually device, behavioural or observational studies.

How do I join one?

Open a study, check the "Is this trial a fit for you?" section, then contact the study team listed on the page. They will ask a few screening questions. Asking is free and does not commit you to anything. Talk it over with your doctor first.

Find the studies that fit you

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