Invasive Breast Cancer

14

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

Condition / disease
Location
Status: Recruiting

A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer

The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. The immediate reconstruction surgery is called an immediate autologous reconstruction (IR) and is different than the standard reconstruction surgery people with T4 breast cancer have. IR is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from your body. The main purpose of this study to find out if the alternative treatment approach shown above is feasible. The study will see how safe this alternative treatment approach is compared with the standard treatment approach.

Participants needed: 60
Trial details
Phase: Phase 1Age: 18+Biological sex: FemaleType: InterventionalSponsor: Memorial Sloan Kettering Cancer CenterUpdated: Jul 2, 2026Locations: 7
Eligibility criteria

Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer [+4]

Prior ipsilateral breast cancer [+7]

Status: Recruiting

Sacituzumab Govitecan In TNBC

This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)

Participants needed: 260
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Massachusetts General HospitalUpdated: Jun 2, 2026Locations: 5
Eligibility criteria

Female or male patients ≥ 18 years of age. [+13]

Inflammatory breast cancer, or locally recurrent breast cancer [+10]

Status: Recruiting

Impact of Vitamin D Supplementation on the Rate of Pathologic Complete Response in Vitamin D Deficient Patients

A two arm pilot study investigating the rate of pathologic complete response in patients with vitamin D deficiency and triple negative breast cancer undergoing standard neoadjuvant chemotherapy + vitamin D supplementation, including an observational arm to describe response in patients who are not deficient. Investigators hypothesize that vitamin D supplementation during neoadjuvant chemotherapy in operable triple negative breast cancer patients with vitamin D deficiency, will increase the rate of pathologic complete response chain reaction to that of vitamin D sufficient patients based on historical controls.

Participants needed: 50
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Wake Forest University Health SciencesUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

Women or men with histologically confirmed invasive mammary carcinoma. [+9]

Patients with nephrolithiasis within the past year. [+7]

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

CONFIRM: Magnetic Resonance Guided Radiation Therapy

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

Participants needed: 70
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Brigham and Women's HospitalUpdated: Feb 9, 2026Locations: 2
Eligibility criteria

Participants must have histologically or cytologically confirmed malignancy requ... [+4]

History of allergic reactions attributed to gadolinium-based IV contrast [+3]

Status: Recruiting

fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases

The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI.

Participants needed: 145
Trial details
Age: 18-75Biological sex: AllType: InterventionalSponsor: European Institute of OncologyUpdated: Jan 6, 2026Locations: 1
Eligibility criteria

Pre or post-menopausal patient with histologically confirmed invasive breast can... [+5]

Absolute contraindications that exclude the execution of the MRI investigation,... [+4]

Status: Recruiting

Organoids From Breast Cancer Patients Treated With Neoadjuvant Therapy

The aim of this study is to establish patient-derived organoid (PDO) and tumor tissue cultures from breast cancer patients, in order to create personalized, accurate, and reliable preclinical models capable of providing information on the diverse biomolecular portraits of breast cancer. These models may also be used to predict the achievement of pathological complete response after neoadjuvant chemotherapy (NAC) treatment, study the biological, molecular, genetic, and microenvironmental characteristics of each tumor, and isolate tumor-derived extracellular vesicles from the PDOs and tissues and analyze them as potential biomarkers of response to NAC.

Participants needed: 240
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Istituti Clinici Scientifici Maugeri SpAUpdated: Dec 3, 2025Locations: 1
Eligibility criteria

Female subjects; [+6]

Patients who have already undergone prior chemotherapy treatments; [+2]

Status: Recruiting

Prospective Breast Cancer Biospecimen Collection

Tissue will be procured during a standard of care procedure the patient will already be scheduled to undergo. A one time blood draw will be performed at this time and an optional rectal swab for biome analysis may occur. Follow Up will only consist of chart review to determine date of recurrence, metastases, and/or death

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Thomas Jefferson UniversityUpdated: Dec 3, 2025Locations: 1
Eligibility criteria

Adults >18 years old at time of consent [+5]

<18 years old [+2]

Status: Recruiting

Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.

Participants needed: 88
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Jonsson Comprehensive Cancer CenterUpdated: Nov 10, 2025Locations: 9
Eligibility criteria

Previously untreated operable invasive carcinoma of the breast greater than 2.0... [+29]

Recurrent or metastatic breast cancer [+27]

Status: Recruiting

(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part. The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it. The Treatment Cohort has been simplified to a single study arm (Z)-endoxifen + goserelin. Up to 20 participants will be enrolled that have a baseline Ki-67 ≤ 10% and 45 participants will be enrolled that have a baseline Ki-67\>10%. A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery. Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.

Participants needed: 87
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: Atossa Therapeutics, Inc.Updated: Oct 30, 2025Locations: 15
Eligibility criteria

Female sex assigned at birth. Female to male transgender individuals who have no... [+14]

Bilateral invasive breast cancer; Inflammatory breast cancer defined as clinical... [+22]

Status: Recruiting

TRUDI: TDXD+Durva in HER2+/Low IBC

The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer. The names of the study drugs involved in this study are: * Trastuzumab deruxtecan * Durvalumab

Participants needed: 63
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: Filipa Lynce, MDUpdated: Sep 19, 2025Locations: 3
Eligibility criteria

Participants must have a histological or cytological diagnosis of invasive breas... [+23]

Has received prior systemic anti-cancer therapy for the current diagnosis of inf... [+22]

Status: Recruiting

Postoperative Radiotherapy in Breast Cancer- Concurrent or Sequential With Chemotherapy

This clinical research aims to determine if concurrent chemotherapy and radiation therapy is more effective than sequential chemotherapy and radiation therapy for patients with stage IIB-III breast cancer. It seeks to answer the following key questions: 1. When compared to sequential treatment, does concurrent chemoradiotherapy increase disease-free survival? 2. What effects does concurrent treatment have on post-operative look, quality of life, and side effects including arm swelling (lymphoedema)? 3. What are each treatment approach's financial costs? Researchers will compare the following to groups: Arm A: Participants in the sequential treatment group will first undergo chemotherapy and then radiation. and Arm B: Participants in the concurrent treatment group will undergo radiation therapy while undergoing chemotherapy. Participants are going to: 1. Get the usual chemotherapy (taxanes and/or anthracyclines). 2. Receive radiation therapy for three to four weeks. 3. Have follow-up visits every 6months for 5years to check for cancer recurrence, side effects, and quality of life.

Participants needed: 858
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Dr. Tabassum WadasadawalaUpdated: Apr 13, 2025Locations: 5
Eligibility criteria

Pathologically confirmed invasive breast cancer [+4]

Hypersensitivity to taxanes [+6]

Status: Not yet recruiting

Evaluation of the RESTART Survival Programme

The RESTART survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. In this project, investigators are going to evaluate the satisfaction of patients taking part in the RESTART programme, as well as measuring changes in quality of life and health literacy after participation in the RESTART programme.

Participants needed: 200
Trial details
Age: 18-99Biological sex: AllType: ObservationalSponsor: Jules Bordet InstituteUpdated: Feb 28, 2025Duration: 15 Months
Eligibility criteria

Age >= 18 at the time of signing the ICF [+4]

Status: Recruiting

Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer

In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment. Over the past two decades, significant changes have occurred in radiotherapy for breast cancer, encompassing dose fractionation methods, radiotherapy techniques, and delineation of the radiation field. Hypofractionated radiotherapy has been reported in numerous randomized phase 3 studies to show equivalent tumor control rates, reduced acute side effects, and similar late side effects compared to conventional fractionation. Among hypofractionated radiotherapy approaches, particularly in early-breast cancer, accelerated partial breast irradiation (APBI) may be chosen over whole breast irradiation (WBI). This approach is based on data indicating that the majority of local recurrences in breast cancer occur around the site of the primary tumor. By targeting radiation to the involved breast region, it becomes possible to increase the dose per fraction while shortening the overall treatment duration due to the smaller radiation treatment volume. While careful patient selection is crucial, multiple clinical studies have demonstrated that APBI, particularly after breast-conserving surgery, yields satisfactory local control rates comparable to WBI. This is accompanied by reduced side effects, improved convenience, enhanced quality of life, and potential cost savings. Traditionally, APBI has been administered after surgery, but there is a recent trend to explore preoperative APBI. The rationale for performing preoperative APBI includes several considerations. Firstly, compared to postoperative APBI, the precise location of visually identifiable tumors allows for more accurate and targeted radiation therapy, minimizing the impact on adjacent normal tissues and achieving superior cosmetic results. Secondly, reducing the size of the preoperative lesion may enable more conservative surgery, decreasing the extent of the surgical procedure. Thirdly, it can serve as a preparatory treatment to assess tumor responsiveness. Fourthly, in some cases, it may be administered for definitive purposes, especially in elderly or frail women who may find it challenging to undergo standard treatment due to concurrent health issues. Several clinical studies have reported the effectiveness and validity of preoperative PBI in a few cases of early breast cancer. These studies have shown low rates of acute and chronic toxicity, with excellent cosmetic outcomes. While accumulating evidence supports preoperative PBI, there is currently a lack of comparative studies with postoperative PBI. Therefore, this study aims to compare and evaluate the overall clinical advantages, including safety and efficacy, of preoperative PBI and postoperative PBI in early breast cancer patients.

Participants needed: 47
Trial details
Phase: Phase 2Age: 45+Biological sex: FemaleType: InterventionalSponsor: Yonsei UniversityUpdated: Nov 7, 2024Locations: 1
Eligibility criteria

Histologically confirmed ductal carcinoma in situ (DCIS) and invasive breast can... [+3]

cN+ [+8]