Breast Cancer Stage IV

18

Review clinical trials related to Breast Cancer Stage IV. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

A Study of Meaning-Centered Therapy for Mexican Adults With Advanced Cancer

The purpose of this study is to find out if Meaning-Centered Psychotherapy for Latinos (MCP-L) helps reduce anxiety and depression and improves quality of life compared to cognitive behavioral therapy (CBT). Investigators also want to learn what participants and providers think about the therapy, including how the therapy is designed, outside factors, available resources, and how the people involved affect how well MCP-L works.

Participants needed: 300
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: Jun 22, 2026Locations: 2
Eligibility criteria

Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, o... [+10]

Prior Treatment [+12]

Status: Recruiting

A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.

Participants needed: 28
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: May 28, 2026Locations: 7
Eligibility criteria

Aged ≥18 years at signing of informed consent. [+18]

Treatment to bone lesions in the calvarium are not eligible for the dose-finding... [+10]

Status: Recruiting

HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission

Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.

Participants needed: 60
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: May 22, 2026Locations: 7
Eligibility criteria

Male or female participants who are ≥18 years old with histologically confirmed... [+17]

Patients diagnosed with HER2+ breast cancer as per American Society of Clinical... [+18]

Status: Recruiting

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.

Participants needed: 30
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: May 20, 2026Locations: 7
Eligibility criteria

Patients ≥ 18 years of age [+21]

Patient not eligible for PD-1 inhibitor per the patient's medical oncologist [+2]

Status: Recruiting

Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer

This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.

Participants needed: 246
Trial details
Phase: Phase 3Age: 18-70Biological sex: FemaleType: InterventionalSponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUpdated: Apr 23, 2026Locations: 7
Eligibility criteria

The subject voluntarily agrees to participate in this study and signs an informe... [+8]

Subjects with untreated active brain metastases or leptomeningeal metastases. [+14]

Status: Recruiting

Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management

This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300). The study integrates digital health tools for proactive toxicity management and potentially facilitate early detection of ILD/pneumonitis.

Participants needed: 300
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: SOLTI Breast Cancer Research GroupUpdated: Mar 27, 2026Locations: 27
Eligibility criteria

Able to understand the nature of the study and to voluntarily provide written in... [+16]

Patients with HER2-negative disease. [+24]

Status: Recruiting

Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy

This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy. Eligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).

Participants needed: 86
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: University of California, DavisUpdated: Mar 4, 2026Locations: 1
Eligibility criteria

Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or... [+17]

Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepi... [+9]

Status: Recruiting

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.

A Phase I/II, Open-label study to assess the safety, tolerability, pharmacokinetic, and antitumor efficacy of FWD1802 monotherapy in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer. This clinical trial aims to explore the role of FWD1802 in the ER+/HER2- advanced breast cancer patient population. The primary objectives are to address the following questions: Phase I Study: Determine the Recommended Phase II Dose (RP2D) and/or Maximum Tolerated Dose (MTD) of FWD1802 in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer. Phase II Study: To evaluate the efficacy of FWD1802 at the RP2D in patients with ESR1-mutated ER-positive/HER2-negative locally advanced or metastatic breast cancer, using objective response rate (ORR) as the efficacy endpoint.

Participants needed: 99
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: Forward Pharmaceuticals Co., Ltd.Updated: Feb 10, 2026Locations: 22
Eligibility criteria

Voluntarily participate in the clinical trial and sign the informed consent form... [+20]

Leptomeningeal metastases, carcinomatous meningitis, spinal cord compression, or... [+37]

Status: Recruiting

SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells

The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.

Participants needed: 24
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: General Oncology, Inc.Updated: Jan 29, 2026Locations: 2
Eligibility criteria

Age ≥ 18 years. [+27]

Rapid disease progression or clinical features concerning for onset of rapid sym... [+65]

Status: Recruiting

HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC

This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy. The overarching aim of the HER2-Ex PET trial is to study the role of precision imaging utilizing positron emission tomography (PET) with the HER2-specific tracer \[68Ga\]Ga-ABY-025 (hereafter referred to as HER2-PET) in enhancing treatment planning for patients with metastatic HER2-expressing breast cancer Patients will be allocated based on HER2-status on PET and biopsy. Patients with HER2-expressing lesions in a fresh or archived tumour biopsy will be treated with T-DXd. The study hypothesis is that PET/CT precision imaging with a contemporary HER2-radiotracer (\[68Ga\]Ga-ABY-025) can be used and can lead to a potentially better identification of patients who benefit from T-DXd treatment, thereby achieving improved treatment responses as well as fewer side effects. This study's diagnostic approach provides a more individualized treatment strategy. Additionally, this study can potentially give us a better biological understanding of HER2-expressing mBC.

Participants needed: 70
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Renske AltenaUpdated: Nov 20, 2025Locations: 1
Eligibility criteria

Female patients age ≥18 years. [+7]

Contra-indications for treatment for trastuzumab deruxtecan and inability to und... [+7]

Status: Recruiting

Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.

Participants needed: 20
Trial details
Phase: Phase 2Age: 18-100Biological sex: AllType: InterventionalSponsor: Medical University of ViennaUpdated: Sep 25, 2025Locations: 1
Eligibility criteria

Histologically confirmed breast cancer [+17]

Known hypersensitivity to Dato-DXd or any of the drug components [+25]

Status: Recruiting

RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study

RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.

Participants needed: 500
Trial details
Biological sex: AllType: ObservationalSponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUpdated: Jun 22, 2025Locations: 1
Eligibility criteria

Patients with metastatic breast cancer underwent a liver, lung, pleural or bone...

Not available imaging (CT scan and/or PET-FdG scan) in the three months before t... [+2]

Status: Recruiting

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

PALMARES-2 is a retrospective/prospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+/HER2- aBC patients treated with first-line CDK4/6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4/6i as first-line of therapy for HR+/HER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.

Participants needed: 3,500
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUpdated: Feb 3, 2025Locations: 24
Eligibility criteria

Diagnosis of HR+/HER2- advanced Breast Cancer (aBC), as defined as at least 1% e... [+1]

Less than 3 months of follow up from the CDK4/6i start to the date of data cut-o... [+2]

Status: Recruiting

A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer

A Phase 1, open-label, dose-escalation clinical trial of MBQ-167 in participants with advanced Breast Cancer for whom Standard of Care (SOC) has failed or has proven intolerable.

Participants needed: 48
Trial details
Phase: Phase 1Age: 21+Biological sex: AllType: InterventionalSponsor: MBQ PharmaUpdated: Dec 12, 2024Locations: 4
Eligibility criteria

The investigator will evaluate these and other criteria to determine whether a p... [+4]

The investigator will evaluate these and other criteria to determine whether a p... [+5]

Status: Not yet recruiting

Inetetamab Combined With Paclitaxel With/Without Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer

This study is designed to comprehensively evaluate the HER2 positive recurrent/metastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent/metastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.

Participants needed: 100
Trial details
Phase: Phase 4Age: 18-70Biological sex: FemaleType: InterventionalSponsor: Fudan UniversityUpdated: Aug 29, 2024
Eligibility criteria

Age 18 - 70 years, female [+9]

Participated in other clinical trials within 4 weeks; [+8]

Status: Recruiting

HR+/HER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan

This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+/HER2- advanced/metastatic breast cancer patients

Participants needed: 50
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: SOLTI Breast Cancer Research GroupUpdated: Jul 19, 2024Locations: 10
Eligibility criteria

Provision of signed and dated, written informed consent form prior to any mandat... [+25]

Patients with HER2-positive or TNBC disease. [+25]

Status: Not yet recruiting

Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis

This is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis.

Participants needed: 384
Trial details
Phase: Phase 4Age: 18-75Biological sex: AllType: InterventionalSponsor: Fudan UniversityUpdated: Sep 26, 2023Locations: 13
Eligibility criteria

18 years old ≤ age ≤ 75, regardless of gender. [+8]

Any other malignancies diagnosed within 5 years prior to enrollment, except thos... [+9]

Status: Recruiting

Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer

TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.

Participants needed: 345
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Vastra Gotaland RegionUpdated: Oct 21, 2022Locations: 1
Eligibility criteria

Histologically or cytological confirmed recurrent OMBC. [+22]

> 1 line of systemic treatment for OMBC due to previous progressing disease (pre... [+7]