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Breast Neoplasms clinical trials

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NCT ID: NCT04768426 Recruiting - Breast Cancer Clinical Trials

Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer

Start date: February 3, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment. Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors. This may inform future clinical trials in which patients could receive a different treatment than capecitabine to reduce their risk of breast cancer relapse.

NCT ID: NCT04767659 Recruiting - Clinical trials for Breast Cancer Female

Monitoring Response to NAC and Prediction of pCR in Breast Cancer Patients Using Optical Imaging

Start date: January 27, 2020
Phase: N/A
Study type: Interventional

Neoadjuvant chemotherapy (NAC) is the first line treatment for locally advanced breast cancer (BC). Besides making breast conserving surgery feasible, its main aim is to achieve a pathological complete response (pCR). Previous studies demonstrated that a pCR correlated with a higher disease-free survival. Tumor response may vary among different BC subtypes and only 30% of BC respond completely to NAC. Treating chemo-resistant disease with NAC may cause patient harm due to drug toxicity and surgery delay. It is therefore very important to promptly identify those women who will not benefit from NAC. Mammography and ultrasound proved ineffective in monitoring changes in lesion size due to therapy-induced fibrosis. MRI is the most accurate imaging technique for assessing early clinical response by measuring tumor size, however its accuracy is lower post NAC. This necessitates the need for a new technique able to non invasively assess the effectiveness of NAC. Optical techniques are sensitive to the biological changes that occur within the tumor after NAC administration. These changes occur prior to tumor size reduction. Optically estimated total hemoglobin concentration correlates with the histological analysis of vasculature as well as with tumor-associated angiogenesis which can affect tumor changes during NAC. Other promising biomarkers related to tissue composition (water, lipid, collagen content) and structure (scattering) may also be evaluated by optical techniques. The aim of the study is to monitor the effectiveness of NAC in BC patients with a near infrared spectroscopic imaging platform which allows to non-invasively detect changes in vascularization and size of BC and to characterize the presence of temporal changes in regional concentrations of relevant biomarkers (oxy- and deoxyhemoglobin, water, lipid and collagen concentration, scattering) within tissue during NAC. This optical imaging technique will provide a non-invasive, safe and relatively inexpensive tool to monitor patients' response to NAC and to predict their outcome.

NCT ID: NCT04767594 Recruiting - Breast Neoplasms Clinical Trials

First-line Palbociclib and Endocrine Therapy for Patients With HR+/HER2- Advanced Breast Cancer in the Real-world Setting.

PERFORM
Start date: October 27, 2020
Phase:
Study type: Observational

This is a prospective, single-arm, multi-center observational non-interventional study (NIS) in Germany and Austria.

NCT ID: NCT04765124 Recruiting - Breast Cancer Clinical Trials

The Efficacy and Safety of Neoadjuvant Trastuzumab Plus Taxane With and Without Pertuzumab Therapy

HER2PATH
Start date: April 29, 2021
Phase:
Study type: Observational

This study is a Non-Interventional Study (NIS) with secondary data usage. It is designed as a multi-center retrospective cohort study in which the data of adult locally advanced HER2-positive breast cancer patients, who are treated with as neoadjuvant therapy, who underwent breast surgery in participating centers, were taken from hospital records. The source population is academic or community oncology centers treating patients with breast cancer from Turkey. The study population is planned to be the subgroup of breast cancer patients, who are treated with trastuzumab plus taxane with or without pertuzumab as neoadjuvant therapy, and underwent breast surgery at the participating centers. The study is anticipated to include approximately 1500 patients from 20 sites.

NCT ID: NCT04762979 Recruiting - Clinical trials for HER2-negative Breast Cancer

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Start date: February 12, 2021
Phase: Phase 2
Study type: Interventional

Patients who have histologically confirmed metastatic or unresectable (not amenable to curative therapy) breast cancer may be screened for eligibility. All patients must have HER2 negative breast cancer with the identified PIK3CA mutation and received at least one line of endocrine therapy. The study will consist of a screening phase, a treatment phase, and a post-treatment phase which includes safety, efficacy, and follow-up. The treatment phase will include taking alpelisib daily in combination with continued use of either Fulvestrant or Aromatase Inhibitor per standard of care until disease progression or unacceptable toxicity.

NCT ID: NCT04759248 Recruiting - Breast Cancer Clinical Trials

Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer

ATREZZO
Start date: March 15, 2021
Phase: Phase 2
Study type: Interventional

Immune checkpoint inhibitors given in monotherapy in advanced breast cancer have shown modest benefit in first-line, but very limited efficacy in later lines. Thus, combination therapies are needed. Response following anti-PD1/PD-L1 monotherapy is associated with large survival benefit in the advanced setting. Previous studies of the intrinsic subtypes have shown that Basal-like and HER2-E are associated with higher expression of immune-related genes or higher infiltration of stromal tumor infiltrating lymphocytes compared to the luminal subtypes. Immune infiltration in BC is associated with chemo/antiHER2 responsiveness and potentially benefit from anti-PD-1/PD-L1 inhibitors. In addition, one emerging biomarker of response to anti-PD-1 therapy is the tumor mutational burden (I.e. the total number of mutations per coding area of a tumor genome). The HER2-E and Basal-like profiles have been associated with high mutational burden. A range of studies have been initiated including several phase II/III studies evaluating atezolizumab in combination with different chemotherapeutic compounds routinely used in breast cancer, but none with predefined biomarker beyond the expression of PD-L1 by IHC

NCT ID: NCT04758780 Recruiting - Clinical trials for Triple Negative Breast Cancer

Imaging Performance Assessment of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Metastatic Triple Negative Breast Cancer Patients

OPALESCENCE
Start date: September 21, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the use of 89Zr-labeled girentuximab (89Zr-TLX250) as a novel, carbonic anhydrase IX (CAIX) targeted PET/CT tracer for the imaging of metastatic triple negative breast cancer (TNBC) patients.

NCT ID: NCT04758416 Recruiting - Breast Cancer Clinical Trials

Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer

Start date: December 31, 2020
Phase:
Study type: Observational

Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer

NCT ID: NCT04756765 Recruiting - Breast Cancer Clinical Trials

Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer

Start date: February 23, 2023
Phase: Phase 2
Study type: Interventional

This purpose of this study is to test if talazoparib is safe and evaluate its response to advanced breast cancer associated with mutation of gene called PALB.

NCT ID: NCT04754412 Recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Culturally Based Brief Expressive Writing Intervention for the Improvement of Health in Chinese Immigrant Stage 0-III Breast Cancer Survivors, Writing to Heal Study

Start date: July 23, 2021
Phase: N/A
Study type: Interventional

This clinical trial studies the effect of a culturally based brief expressive writing intervention in improving the health of Chinese immigrant stage 0-III breast cancer survivors. Culturally based brief expressive writing interventions may help researchers learn more about the experiences of Chinese immigrant breast cancer survivors and how writing about their experiences may affect their health.