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Breast Cancer clinical trials

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NCT ID: NCT05663294 Recruiting - Breast Cancer Clinical Trials

PBI for Breast In Situ Carcinoma of Intermediate Low Risk as Local Adjuvant Treatment

PRISCILLA
Start date: January 9, 2023
Phase: N/A
Study type: Interventional

Screening and advances in breast imaging led to a continuous increase of Ductal Carcinoma in situ (DCIS) diagnosis. Whole breast radiotherapy was reported to be effective in reducing the risk of local recurrence in all analyzed patients and tumor characteristics. In order to de-escalate treatment in low and intermediate DCIS, it is possible to investigate the role of partial breast irradiation (PBI). To date, data from available literature supports the hypothesis that PBI is a safe well tolerated therapy that appears to be equivalent to WBI in terms of efficacy and ultimate breast cosmesis.

NCT ID: NCT05659797 Recruiting - Breast Cancer Clinical Trials

FES BPET-DBT in Newly Diagnosed Breast Cancer

Start date: October 2, 2023
Phase: Early Phase 1
Study type: Interventional

Patients with newly diagnosed primary estrogen-receptor (ER) positive breast cancer, with at least one breast lesion that is 1.0 cm in diameter or greater, may be eligible for this study. Patients may participate in this study if they are at least 18 years of age. Up to 20 evaluable subjects will participate in a single imaging cohort. Study subjects will undergo imaging of the breast with a novel device combining dedicated Breast Positron Emission Tomography (BPET) and Digital Breast Tomosynthesis (DBT) following intravenous injection of [18F]-Fluoroestradiol (FES). This is an observational study; FES-BPET/DBT will not be used to direct treatment decisions. While patients and referring physicians will not be blinded to the FES-BPET/DBT results, treatment decisions are made by the treating physicians based upon standard clinical imaging.

NCT ID: NCT05659563 Recruiting - Breast Cancer Clinical Trials

Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%

EMPRESS
Start date: July 20, 2023
Phase: Phase 2
Study type: Interventional

This study is a window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) or tamoxifen in estrogen receptor-positive (ER[+])/human epidermal growth factor receptor 2-negative (HER2[-]) primary invasive adenocarcinoma of the breast with Ki67 level ≥ 10%. A total of 92 patients will be enrolled in this trial and randomized 1:1 in the arm A with giredestrant (GDC-9545) and the arm B with tamoxifen, with a total duration of treatment of 15 days. This study will analyze the efficacy of giredestrant (GDC-9545) as determined by Ki67 expression between baseline tumor biopsy samples and post-treatment biopsy samples.

NCT ID: NCT05659056 Recruiting - Breast Cancer Clinical Trials

Neoadjuvant Study With Pyrotinib and Trastuzumab and Abraxane in Patients With HER2-enriched Breast Cancer

Start date: November 29, 2022
Phase: Phase 2
Study type: Interventional

Breast cancer is kind of highly heterogeneous tumor. The patients with the same stage and with the same treatment regimen, their prognosis varies greatly, mainly due to the different phenotypes of breast cancer and different sensitivities to drug therapy. PMA50 and BluePrint classification divides breast cancer into other inherent subtypes: Luminal A, Luminal B, HER2-enriched (HER2-E) and Basal-like. Previous studies have shown that these patients with inherent subtype of HER2-enriched are more likely to obtain higher pCR after anti-HER2 therapy. And more study and meta analysis had demonstrated the higher pCR is closely related to EFS. The genetic and molecular typing of breast cancer is closely related to the prognosis of breast cancer, so it is imperative to seek a new treatment regimen for precision treatment and maximize the therapeutic benefit of HER2-enriched patients.

NCT ID: NCT05658341 Recruiting - Breast Cancer Clinical Trials

Program of Physical Activity, Nutrition and Supportive to Improve the Quality of Life of Breast Cancer Survivors

ADA
Start date: November 6, 2023
Phase: N/A
Study type: Interventional

Despite it being one of the leading causes of cancer death among women, survival following a breast cancer diagnosis has greatly increased in high-income countries. However; this gave rise to a growing population of women living long after breast cancer with a diminished quality of life (QoL) due to the long-term effects of cancer and cancer treatment. Exercise can improve QoL, fatigue, and other mental and physical health outcomes in this population, and is strongly recommended among breast cancer survivors, much like a healthy diet. However adherence in real-life to these recommendations is seldom satisfactory. Also, evidence regarding the effect and cost-effectiveness of concurrent healthy lifestyle behaviors compared to exercise alone is limited. Hence the need to develop pragmatic (evaluating the effectiveness of interventions in real-life conditions) theoretical-based customized interventions, which aim to improve uptake and instill long-term adherence of health lifestyle among breast cancer survivors. ADA (Activité physique adaptée Doublée d'un Accompagnement spécifique post-cancer) is an integrative intervention based on physical activity, nutrition and supportive care. The interventions aims to improve breast cancer survivors' physical and mental health and instill long-term healthy behaviors. Our study will be a pragmatic two-arm (ADA intervention versus control/usual care) cluster randomized controlled trial which examines the effectiveness of the ADA intervention program. The primary endpoint will be health-related quality of life, as measured at 12-month after the start of the trial. Several secondary outcomes will also be assessed; which include Physical activity level, relationship to food and self-efficacy. The study aims to recruit 160 participants in total, divided into 20 activity groups (clusters) of 8 participants. Primary analyses will be carried out on an intention to treat (ITT) basis, at both cluster and participant level. All statistical analysis will adjust for the clustering of patients within centers as a random effect. The aim of this trial is to provide scientific evidence on the 'real-world' effectiveness of an easily generalizable trial, with clinically-significant outcomes, touching a growing number of cancer survivors.

NCT ID: NCT05658172 Recruiting - Breast Cancer Clinical Trials

Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer

SURVIVE
Start date: December 7, 2022
Phase: N/A
Study type: Interventional

The goal of this clinical study is to evaluate the potential benefits of intensified surveillance versus standard surveillance in medium-risk and high-risk early breast cancer patients. The main questions it aims to answer are: - Comparison of the 5-year ob´verall survival rates between patients in the Standard Surveillance arm versus patients in the liquid-biopsy guided Intensive Surveillance arm - Determination of the Overall Lead Time Effect generated due to tumor marker/CTC/ctDNA guided Intensive Surveillance compared to Standard Surveillance after primary therapy in early breast cancer patients. Participants will recieve regular blood drawals. Solely the blood samples of the intensive surveillance arm will be analysed for prospective tumor markers/CTCs/ctDNAs. Abnormal findings of either marker will trigger diagnostic imaging to search for possible metastases. The blood samples of the standard surveillance arm will solely be biobanked for future research purposes.

NCT ID: NCT05656716 Recruiting - Breast Cancer Clinical Trials

Multimodal Project

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

The main aim of this study is to determine the effect of a multimodal intervention (Nutrition and Exercise) on quality of life, emotional well-being, and secondary symptomatology in patients diagnosed with breast cancer during neoadjuvant chemotherapy treatment, and to compare them with the control group.

NCT ID: NCT05656079 Recruiting - Breast Cancer Clinical Trials

To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study

easy laugh
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

To evaluate the safety and efficacy of pegylated liposomal doxorubicin/cyclophosphamide/trastuzumab/pertuzumab followed by docetaxel/ trastuzumab/pertuzumab compared with epirubicin/cyclophosphamide followed by docetaxel/trastuzumab/pertuzumab in the adjuvant treatment of early breast cancer.

NCT ID: NCT05654532 Recruiting - Breast Cancer Clinical Trials

Study of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer

Start date: December 29, 2022
Phase: Phase 1
Study type: Interventional

This clinical trial is evaluating a drug called AC699 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to: - Identify the recommended dose of AC699 that can be given safely to participants - Evaluate the safety profile of AC699 - Evaluate the pharmacokinetics of AC699 - Evaluate the effectiveness of AC699

NCT ID: NCT05654246 Recruiting - Breast Cancer Clinical Trials

Susan G. Komen's ShareForCures

Start date: November 17, 2022
Phase:
Study type: Observational [Patient Registry]

ShareForCures (SFC) is a community-based participatory research registry, and its prime objective is to engage participants representative of the United States breast cancer patient population -including minoritized and historically marginalized people, persons, or communities-to ensure the data researchers use to study breast cancer is as diverse as the people touched by this disease. In doing so, researchers will have a better understanding of breast cancer, and everyone can potentially benefit from scientific advances and improvements in care.