Breast Neoplasm Female

16

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

Condition / disease
Location
Status: Recruiting

A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)

The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

Participants needed: 910
Trial details
Phase: Phase 3Age: 50-120Biological sex: FemaleType: InterventionalSponsor: Ontario Clinical Oncology Group (OCOG)Updated: Jun 18, 2026Locations: 29
Eligibility criteria

Female with a new histological diagnosis of invasive carcinoma of the breast wit... [+2]

Age less than 50 years. [+11]

Status: Recruiting

Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.

Participants needed: 50
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of Wisconsin, MadisonUpdated: Jun 16, 2026Locations: 2
Eligibility criteria

Women with pathologically demonstrated breast cancer [+10]

History of allergic reactions attributed to compounds of similar chemical or bio... [+4]

Status: Not yet recruiting

Targeting Stress-Driven Inflammatory and Angiogenic Pathways With Brief ACT to Enhance Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer

This clinical trial aims to learn whether a brief psychological therapy called Brief Acceptance and Commitment Therapy (Brief-ACT) can improve the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer. It will also examine how this therapy affects stress levels and certain blood markers related to inflammation and tumor growth. The main questions this study aims to answer are: Does Brief-ACT improve the rate of pathological complete response (pCR) after chemotherapy? Does Brief-ACT reduce levels of inflammatory and angiogenic biomarkers such as C-reactive protein (CRP), interleukin-6 (IL-6), neutrophil-to-lymphocyte ratio (NLR), and vascular endothelial growth factor (VEGF)? Does Brief-ACT reduce psychological stress in patients undergoing chemotherapy? Researchers will compare patients who receive Brief-ACT in addition to standard chemotherapy with those who receive standard chemotherapy alone to see if there are differences in treatment response, stress levels, and biomarker levels. Participants will: Receive neoadjuvant chemotherapy according to standard treatment protocols Be assigned to receive Brief-ACT sessions or no additional psychological intervention Attend regular clinic visits for treatment and monitoring Provide blood samples at specific time points for laboratory analysis Complete questionnaires to assess psychological stress

Participants needed: 54
Trial details
Age: 40-65Biological sex: FemaleType: InterventionalSponsor: Universitas AirlanggaUpdated: May 6, 2026
Eligibility criteria

Female patients aged 40-65 years [+5]

Severe psychological distress defined as Perceived Stress Scale (PSS-10) score ≥... [+4]

Status: Recruiting

Feasibility and Acceptibility of a Multi-site Trial of Time Restircted Eating During Chemotheraply for Breast Cancer.

This study is being done to better understand how time restricted eating (eating all food in an 8 hour window) can help a person receiving chemotherapy treatment for breast cancer, stages I-IV. The aim is to find out if time restricted is feasible and acceptable to individuals starting chemotherapy for breast cancer. We will test 3 different eating window options compared to a control group for 24 weeks.

Participants needed: 40
Trial details
Age: 25-99Biological sex: FemaleType: InterventionalSponsor: University of Illinois at ChicagoUpdated: May 1, 2026Locations: 2
Eligibility criteria

Age 25-99 at time of consent [+8]

Women with type 1 or insulin dependent type 2 diabetes [+18]

Status: Not yet recruiting

HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery

This study evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS). After lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing. Based on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.

Participants needed: 228
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Hôpital du ValaisUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

Female patient, aged 18 years or older at time of surgery. [+5]

Pregnancy (confirmed or suspected) at time of surgery. [+5]

Status: Recruiting

A Novel Approach in the Evaluation of Breast Masses With Doppler US

In cases with breast masses, Doppler resistive index values will be calculated for the mass and surrounding healthy tissue and the opposite healthy breast tissue, and their effect on distinguishing between benign and malignant masses will be evaluated.

Participants needed: 90
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Ahmet YesildagUpdated: Mar 16, 2026Locations: 1
Eligibility criteria

Those with solid breast masses [+2]

Hypovascular masses [+2]

Status: Recruiting

The FYI on MRI: A Multilevel Decision Support Intervention for Screening Breast MRI

The purpose of this study is to test the impact of a multilevel decision support intervention on informed decisions about breast MRI among high-risk Black and Latina women. Participants (N=80) will be randomized to (1) enhanced usual care (risk assessment + referral to nurse practitioner) or (2) decision support (enhanced usual care + decision aid). Assessments will take place at baseline (T0) and 1-month post-intervention (T1). The primary outcome is informed decisions about breast MRI at T1.

Participants needed: 80
Trial details
Age: 18-74Biological sex: FemaleType: InterventionalSponsor: Georgetown UniversityUpdated: Sep 30, 2025Locations: 1
Eligibility criteria

female [+6]

aged <18 or ≥75 [+1]

Status: Not yet recruiting

Piloting 18F-FAPI PET/MRI for Applications in Breast Cancer

Breast cancer is the most common type of cancer in Norwegian women, with 4,224 new cases in 2022. More precise diagnosis are expected to result in more accurate assessment of treatment effect, and to contribute to both providing better treatment and reducing overtreatment. Fibroblast activating protein (FAP) is expressed in the tumor stroma of 90% of all epithelial-based tumors, including breast tumors. Inhibitors for this protein (FAPI) has been developed for use as radioactive tracers. Breast tumors of various histopathological types, and local metastatic lymph nodes, have shown high uptake for such tracers. The main aim of this project is to establish 18F-FAPI PET/MRI for use in breast cancer in a wide range of disease stages. We will evaluate how FAPI PET/MRI correlates with histopathological assessment, the method's ability to grade tumors - including assessment of treatment - compared to CT, scintigraphy and FDG PET/CT, and ability to detect local recurrence.

Participants needed: 60
Trial details
Age: 18-80Biological sex: FemaleType: InterventionalSponsor: St. Olavs HospitalUpdated: Sep 18, 2025
Eligibility criteria

Inclusion criteria are accepting to undergo 18F-FAPI PET/MRI examinations and [+4]

other primary malignancies than breast cancer, renal insufficiency or know aller...

Status: Recruiting

SBRT in Early Breast Cancer in Elderly Women

Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy. In Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor. In recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery. Stereotactic Radiotherapy is a non-invasive treatment with ablative intent obtained with highly focused high intensity fields for a few fractions (generally 1-5). It is the standard treatment for surgically inoperable lung cancers, and is also used in the treatment of liver metastases, intermediate-risk prostate cancer and locally advanced pancreatic cancers. The applications of stereotactic treatment in breast cancer are limited to the neoadjuvant and adjuvant setting. Against this backgroung, in elderly patients with localized breast cancer candidates for hormonal therapy and non-fit for surgery due to age or comorbidity, a SBRT could more effectively control local disease, not excluding local treatment rather than in itself it is considered very important.

Participants needed: 30
Trial details
Age: 75+Biological sex: FemaleType: InterventionalSponsor: University of Rome Tor VergataUpdated: May 30, 2025Locations: 1
Eligibility criteria

Age ≥ 75 years [+3]

Metastatic Disease [+4]

Status: Recruiting

Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy

In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication. In this trial the safety of the delayed-immediate reconstruction method is tested, where a skin sparing mastectomy and reconstruction with silicone implant is performed at primary surgery to save the native skin for the final delayed reconstruction.

Participants needed: 590
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Danish Breast Cancer Cooperative GroupUpdated: Feb 6, 2025Locations: 8
Eligibility criteria

Woman >18 years who are offered a mastectomy for invasive breast can-cer pT1-3,... [+6]

Pregnant or lactating. [+7]

Status: Recruiting

Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies

The incidence of breast cancer and its mortality are reduced thanks in particular to early detection. Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act. Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination. Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management. However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.

Participants needed: 100
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Hospital St. Joseph, Marseille, FranceUpdated: Sep 19, 2024Locations: 1
Eligibility criteria

aged 18 or over, [+4]

having a major hearing loss, [+5]

Status: Recruiting

Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib

Combining a fitness tracker technology with real-time patient-reported outcome monitoring associated with interventions through a health care app is a novel strategy to evaluate metastatic breast cancer patients using Palbociclib and endocrine treatment.

Participants needed: 68
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Beneficência Portuguesa de São PauloUpdated: Aug 26, 2024Locations: 4
Eligibility criteria

Female patients ≥ 18 years of age diagnosed with hormone receptor-positive/ huma... [+5]

Patients considered to be at poor medical risk due to uncontrolled serious medic... [+4]

Status: Recruiting

A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer

This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0/is, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.

Participants needed: 154
Trial details
Age: 18-75Biological sex: FemaleType: InterventionalSponsor: Wang OuchenUpdated: Jan 31, 2024Locations: 1
Eligibility criteria

Female patients aged 18-75 years old; [+4]

IV (metastatic) breast cancer; [+8]

Status: Not yet recruiting

Intelligent Remote Intervention for High-risk Breast Cancer Populations

The goal of this clinical trial is to compare the effects of modern remote health intervention regime with traditional in-person intervention strategies for high-risk breast cancer groups that with BI-RADS 3 or higher nodules. The main questions it aims to answer are: * Can the remote health intervention be more effective in slowing down the progression of breast nodules than the traditional in-person intervention? * Can the remote health intervention be more effective in minimizing the deterioration of the disease and reducing the risk of death in patients than the traditional in-person intervention? * Can the knowledge, belief and behavioral change of breast nodule population improve after receiving remote health intervention compared with traditional health management model? Participants will be divided into 2 groups, the Experimental group and the Control group. Participants in the Experimental group will be offered with modern remote interventions for 2 years, as describe below: * Teleconsultations: This involves using video calls, or phone calls once a month to connect patients for consultations, follow-ups, and discussions about conditions and symptom management. * Remote Monitoring and Wearable Devices: Wearable devices and remote monitoring tools like Infrared Breast Temperature Detector and Dynamic blood pressure detector will be used once a week to track patients' vital signs and symptoms remotely. * Mobile Applications: Specialized mobile apps will be used to provide a platform for patients to access educational materials, track their progress, manage management schedules, record symptoms, and connect with support groups or online communities. * Educational Platforms and Remote Health Education: Online platforms and resources provide educational materials about breast cancer, treatment options, potential side effects, lifestyle adjustments, and overall wellness. These resources empower patients by providing comprehensive information. Participants in the Control group will be offered with traditional strategies provided in the 'Breast Cancer Screening Guideline for Chinese Women': Ultrasound follow-up review is recommended no less than 3 to 6 months later. If there is no change at 2-year follow-up, it can be downgraded to BI-RADS 2; if there is suspicious change in the lesion during follow-up, biopsy should be considered to clarify the nature of the pathology.

Participants needed: 1,250
Trial details
Age: 18-60Biological sex: FemaleType: InterventionalSponsor: Qianfoshan HospitalUpdated: Jan 5, 2024
Eligibility criteria

Female; Age>=18; Having breast BI-RADS 3 nodules or higher; Informed consent sig...

Having any other known breast diseases; Having any major malignant diseases; Hav...

Status: Recruiting

Comprehensive Analysis of Spatial, Temporal and Molecular Patterns of Ribociclib Efficacy and Resistance in Advanced Breast Cancer Patients

This is a single-arm, open-label phase IV study of patients with advanced HR+/HER2- breast cancer who are treated first line with ribociclib and standard of care endocrine treatment according to SmPC.

Participants needed: 1,000
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: Institut fuer FrauengesundheitUpdated: Apr 18, 2023Locations: 52
Eligibility criteria

Indication for treatment with ribociclib in combination with endocrine therapy i... [+9]

Concurrent participation in a study with an investigational agent/device or with... [+11]

Status: Recruiting

The Efficacy and Safety of Anlotinib Combined With Fulvestrant in Patients With Advanced Breast Cancer

The management of HR-positive, HER2-negative metastatic breast cancer includes endocrine monotherapy or combination regimens, both with benefit diminishing as resistance develops. Nowadays, various studies have demonstrated that estrogen interacts with many angiogenic pathways and is an important mechanism for resistance leading to the question of whether combination with antiangiogenesis and antiestrogen therapies could be an appropriate therapeutic modality. Anlotinib is a novel multi-target tyrosine kinase inhibitor that effectively inhibit VEGFR, FGFR, PDGFR, c-KIT, c-MET and RET. Previous studies have proven the efficacy of both anlotinib monotherapy and combination regimens in advanced breast cancer. This phase II study aims to preliminarily evaluate the efficacy and safety of anlotinib combined with endocrine therapy.

Participants needed: 40
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: Zhejiang Cancer HospitalUpdated: Oct 12, 2021Locations: 1
Eligibility criteria

Aged 18 years or older female; [+9]

Have received prior fulvestrant or anti-angiogenic drug treatment, or known to b... [+16]