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Invasive Breast Cancer clinical trials

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NCT ID: NCT06328465 Recruiting - Clinical trials for Triple Negative Breast Cancer

fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases

fREEDOM
Start date: November 22, 2019
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06158217 Recruiting - Clinical trials for Invasive Breast Cancer

Effect of Ultrasound Combined With Microbubbles on Blood Perfusion in Invasive Breast Cancer

Start date: September 29, 2022
Phase:
Study type: Observational

Blood perfusion insufficiency and hypoxia are the main causes of drug resistance to chemotherapy in breast cancer. Increasing blood perfusion can improve drug delivery. The cavitation effect of ultrasound-stimulated microbubbles (USMBs) is known to enhance tumor blood perfusion, so we conducted a prospective human study to investigate the effects of USMBs on hemoperfusion in invasive breast cancer (IBC).

NCT ID: NCT05795101 Recruiting - Breast Cancer Clinical Trials

TRUDI: TDXD+Durva in HER2+/Low IBC

TRUDI
Start date: May 4, 2023
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT05607004 Recruiting - Breast Neoplasms Clinical Trials

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

EVANGELINE
Start date: February 14, 2023
Phase: Phase 2
Study type: Interventional

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal (still having periods) women with ER+/HER2- breast cancer. (Z)-endoxifen is a selective estrogen receptor modulator or "SERM." SERMs work to treat cancer by blocking the body's natural estrogen from binding to cancer cells. This study includes a pharmacokinetic part (PK, how the drug works in your body) and a treatment part. The primary purpose of the study is to see how (Z)-endoxifen works on tumor cell growth by monitoring a cancer marker called Ki-67. Ki-67 will be measured by biopsy of the breast after about 4 weeks of treatment. If your cancer is responding to treatment based on the Ki-67 results, you may continue treatment up to 24 weeks or until surgery. The PK part of the study will be enrolled first, enrolling about 18 study participants who will all receive oral once daily (Z)-endoxifen treatment. 12 of these participants will be randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or (Z)-endoxifen + goserelin (a medication given to block the ovaries from making estrogen and is also called ovarian suppression). This part of the study will help select the dose of (Z)-endoxifen to use in the treatment part by measuring the levels of (Z)-endoxifen in the blood stream and determine how long it takes for the body to remove it. About 160 study participants will be enrolled in the treatment part. The treatment part will help to determine how oral once daily (Z)-endoxifen, when taken by itself, compares to oral once daily exemestane (a medication that decreases the amount of estrogen in the body, also known as an aromatase inhibitor) and monthly injections of goserelin. Exemestane and goserelin taken together is a standard treatment regimen for premenopausal patients with ER+/HER2- breast cancer. Study participants are randomly assigned to treatment with an equal (50/50) chance to be assigned to (Z)-endoxifen or standard treatment. Study participation is up to 24 weeks of treatment followed by surgery.

NCT ID: NCT05412225 Recruiting - Breast Cancer Clinical Trials

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

Start date: June 6, 2022
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT05383196 Recruiting - Breast Cancer Clinical Trials

Onvansertib + Paclitaxel In TNBC

Start date: September 30, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This research is being done to evaluate the safety and effectiveness of Onvansertib in combination with Paclitaxel in triple-negative breast cancer (TNBC) that has spread to other parts of the body. The names of the study interventions involved in this study are: - Onvansertib - Paclitaxel

NCT ID: NCT05318274 Recruiting - Clinical trials for Invasive Breast Cancer

Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

Start date: April 26, 2021
Phase: N/A
Study type: Interventional

An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.

NCT ID: NCT04677816 Recruiting - Clinical trials for Vitamin D Deficiency

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

Start date: October 22, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04648904 Recruiting - Clinical trials for Invasive Breast Cancer

Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer

Start date: November 24, 2020
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to see whether providing radiation on a shortened (compressed) schedule of 5 days in a row is a safe and effective approach to prevent cancer from coming back in people who have had a mastectomy.

NCT ID: NCT04553770 Recruiting - Clinical trials for Stage II Breast Cancer

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

Start date: October 9, 2020
Phase: Phase 2
Study type: Interventional

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.