Clinical trials for stage 2 breast cancer

The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed by primary disease site to determine toxicity patterns. Secondary Outcome Measures : Disease-free survival [ Time Frame: Time from registration to documentation of disease recurrence, second primary, or death without disease recurrence or second primary, assessed up to 12 months ] The distribution of disease-free survival will be estimated using the method of Kaplan-Meier for each disease group breast cancer; ovarian cancer.

Overall survival time [ Time Frame: Time from registration to death due to any cause, assessed up to 12 months ] The distribution of overall survival times will be estimated using the method of Kaplan-Meier for each disease group breast cancer; ovarian cancer.

Percentage change in plasma concentration of cytokines and chemokines [ Time Frame: Baseline to up to 12 months ] The percent change in plasma concentrations of cytokines and chemokines from pre-treatment concentrations will be determined.

Will be plotted against time with the points belonging to a particular individual connected. Each graph will be visually inspected for trends across time and difference between treatment regimens. Other Outcome Measures: FR-alpha -specific antibody response by enzyme linked immunosorbent assay [ Time Frame: Up to 12 months ] A vaccine-induced FR-alpha-specific antibody responses will be defined as 1 a 2-fold or greater increase in FR-alpha-specific antibody concentration from pretreatment levels at any point during treatment or 2 FR-alpha-specific antibodies above the lower limit of detection at any point during treatment if pre-treatment levels were non-detectable.

Percent change in antigen-specific cytokine profiles [ Time Frame: Baseline to up to 12 months ] Percent change in plasma concentrations of cytokines from pre-treatment levels will be examined to determine skewing of the T cell response to type 1 helper cell or type 2 helper cell after vaccination. Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Uncontrolled acute or chronic medical conditions including, but not limited to the following:. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

Search for terms. The purpose of this study is to evaluate the correlation of exercise cardio magetic resonance imaging CMR parameters left and right ventricular contractile reserve and dose of anthracycline.

The objectives of the study are to first identify, in open-label single-arm Phase I, a recommended Phase II dose of GSK that may be combined safely with fulvestrant.

Phase I will follow a modified toxicity probability interval mTPI design, and a sentinel group will be evaluated first for dose-limiting toxicity and further expanded The purpose of this study is to examine how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection.

Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery. The purpose of this study is to determine the usefulness and effectiveness of Muse, a brain sensing headband intervention, to affect quality of life, stress, fatigue and sleep in newly diagnosed breast cancer patients who are undergoing surgical treatment.

The primary purposes of this trial are to determine the safety and tolerability of RBX given for at least 2 weeks and not more than 4 weeks prior to surgery, and to evaluate intratumoral immune system resonse, including TILs, CD4, and CD8 T cells, in operable breast cancer patients. Many hormone receptor positive breast cancers demonstrate overexpression of cyclin D. LY demonstrates suitable physical and pharmacokinetic PK properties, an acceptable toxicity profile in The purpose of this study is to see if having different kinds of bacteria genes in breast tissue may be connected to the risk of getting breast cancer.

The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer.

PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

The purpose of this study is to evaluate how well radiation therapy with or without olaparib works in treating patients with inflammatory breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. It is not yet known whether radiation therapy with or without olaparib may work better in treating patients with inflammatory breast cancer. Rationale: Gathering medical information and tumor samples from patients with male breast cancer may help doctors learn more about the disease.

Purpose retrospective part: to perform a large international retrospective analysis of clinical and biological data of male BC patients treated in the participating centers from to Purpose prospective part: to create a registry of men with breast cancer for a period of 30 months starting early The purpose of this study is to improve the interpretation of mutations in breast cancer predisposition genes.

This will be accomplished by recruiting members of families found to carry deleterious mainly protein truncating mutations and evaluating co-segregation of the mutations with cancer within families. The purpose of this study is to evaluate the use of molecular breast imaging as an accurate way to assess the response of breast cancer tumors to chemotherapy or hormone therapy that is newly supplemental to the standard treatment.

The purpose of this study is to evaluate if Magseed is a viable alternative to radioactive seed as a localization method for biopsy proven metastatic breast carcinoma following neoadjuvant chemotherapy. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. The purpose of this study is to evaluate the impact of blood collection tube type and processing methods on ctDNA, evaluate the impact of long-term storage of plasma and extracted DNA, and evaluate ctDNA levels at baseline and during treatment for patients with Stage I-III breast cancer.

Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumor cells. A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes.

Quality of life is the outcome measure for the estimated primary completion date of November, The aim of this study is to examine alterations in the skin microbiome that occur during radiation therapy. The study design will examine changes secondary to ionizing radiation, and correlate these changes with the development and severity of radiation dermatitis.

The goal is to improve understanding of the mechanism of radiation dermatitis. These interventions are becoming increasingly popular in cancer survivors. However, little is known about the feasibility and effect of MBIs administered during the interval of time of chemotherapy, on QOL and stress.

The investigators are planning a MBI intervention study developed specifically for breast cancer survivors receiving chemotherapy usually months at the investigators institution, for at least 8 sessions combined with at least 8 weeks of home-practice, in 25 women GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids cfNAs to develop blood tests to detect cancer early.

The purpose of this study is to train and validate an assay to detect invasive breast cancer in patients undergoing mammography. Giving the drugs in different combinations may kill more breast cancer cells.

Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer. This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin t rastuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer.

After surgery, patients will be randomized to receive either pertuzumab or placebo intravenously iv every 3 weeks for one year, in addition to cycles of chemotherapy and 1 year of Herceptin trastuzumab iv every 3 wee ks.

Anticipated time on study treatment is 52 weeks. This research is being done to determine if early changes on a type of imaging procedure called PET Positron Emission Tomography can predict which patients are most likely to respond to the combination of trastuzumab and pertuzumab when given prior to surgery.

This phase II trial studies how well FASN inhibitor TVB and trastuzumab plus either paclitaxel or endocrine therapy with an aromatase inhibitor work in treating patients with HER2 positive breast cancer that has spread to other places in the body. Drugs used in chemotherapy, such as paclitaxel and trastuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Endcocrine therapy helps reduce The purpose of this trial is to determine the patient's pathological response after hypofractionated radiotherapy to the whole breast based on a specimen after surgery.

The analysis of tumor mutation may lead to a better understanding of the effect of radiotherapy in breast cancer. The purpose of this study is to assess whether patients undergoing a breast MRI magnetic resonance imaging before breast surgery will have better results after the surgery.

Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves the ability to evaluate tumors and decide what kind of surgery is best for the patient. This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.

Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear. The investigators hypothesize that Molecular Breast Imaging MBI can more accurately distinguish dense tissue on mammography which is at high risk from dense tissue at low risk by indicating cellular activity in dense tissue as radiotracer uptake functional density in the breast.

In this pilot study, the investigators want to compare the histological characteristics of breast tissue in patients with who have similar density on mammography but different levels of functional density on MBI. The primary purposes of this study are to is to assess safety and tolerability of IV administration of TVH vaccine alone and in combination with HER2 antibodies in patients with advanced cancer.

The primary objective of this study is to compare progression-free survival PFS in patients with advanced HER2-positive breast cancer treated with T-DM1 and abemaciclib vs. T-DM1 monotherapy. The goal of this research is to identify risk profiles of women with particular emphasis on Hispanic women for breast cancer based on family history, breast density and other factors known to impact risk such as age, weight, age at menarche, age at birth of first child, etc.

The purpose of this research study is to understand the views and experiences of Non-Hispanic Black women with a diagnosis or who support a family member with breast or ovarian cancer. We also want to know participant thoughts on genetic testing for cancer risk and research participation.

This is a qualitative interview study. Study participation involved talking on the phone or videoconference e. The purpose of the study is to alleviate the occurrence of chemotherapy-induced nausea CIN and to improve chemotherapy treatment outcomes. Recent research has shown that changes in the functions performed by the gut microbiome can cause the occurrence of chemotherapy-induced symptoms that include chemotherapy-induced nausea.

The investigators are conducting a longitudinal cohort study of young women with breast cancer. The investigators identify women age 40 and younger with newly-diagnosed breast cancer from academic and community healthcare institutions. After women consent to the study, they fill-out surveys and give blood samples, and the investigators collect tissue from their breast cancer tumor after it is removed.

Women are surveyed every 6 months for the first 3 years after diagnosis, then yearly thereafter for an additional 7 years for a total follow-up of at least 10 years following diagnosis. The study investigates short and long-term disease and treatment The purpose of this study is to culture human mammary cells to identify cellular characteristics associated with lobular involution status.

The information will also provide information to assist in improving the quality of care given to patients. The purpose of this trial is to determine the safety of 15 fraction vs 25 fraction pencil beam scanning proton radiotherapy after mastectomy in patients requiring regional nodal irradiation. Proton therapy is recognized as a standard option for the delivery of radiotherapy for breast cancer. This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body.

Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells or reducing the amount of estrogen made by the body. Giving alisertib with or without fulvestrant may be better in treating patients with breast cancer. This study is being performed to better understand the mechanisms behind severe radiation toxicity of a patient with severe fibrosis after breast radiation.

The purpose of this study is to assess the effect of acculturation, socio-economic status SES and place of residence urban vs. The purpose of this study is to determine if exercise improves cardiac remodeling as a way to mitigate the negative effects of chemotherapy and radiation therapy which lead to reduced exercise tolerance.

The purpose of this study is to evaluate the change of vulvovaginal symptoms score from baseline to 6 months in premenopausal women with stage 0-III breast cancer treating with ovarian suppression in combination with aromatase inhibitors. Study will also collect data from investigators are Mayo Clinic and the Mayo Clinic Health Systems to determine effectiveness of the proposed process. The purpose of this study is to assess the antitumor activity of TAS as monotherapy or in combination with Fulvestrant in the treatment of patients with metastatic breast cancer harboring fibroblast growth factor receptor FGFR amplifications.

The survey study will answer the question as to whether consultation with a radiologist increases patient knowledge about supplemental screening exams available to women with dense breasts.

We hypothesize that women with dense breast tissue do not know the supplemental screening exams that are available to them and their knowledge will increase after consulting with a radiologist. If this proves to be true, then the consultation is successful and consideration to implement a similar clinic at other institutions should be given.

The survey will also evaluate patient satisfaction with the consultation. The significance of this study is that it will be the first prospective trial to compare MBI, a relatively low-cost functional breast imaging technique, to DBT, the new standard anatomic breast cancer screening technique in women with dense breasts.

This study is also the first to evaluate two consecutive annual MBI scans to assess change in advanced cancer presentation after introduction of a functional imaging technique.

These data will inform individualized decisions on supplemental screening and determine if a functional technique that is relatively low in cost and complexity of interpretation can eliminate the reservoir of clinically important breast cancers MK may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Hormone therapy using anastrozole and goserelin acetate may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving MK, anastrozole, and goserelin acetate together may kill more cancer cells. The purpose of this study is to estimate the performance sensitivity, specificity, accuracy of dual-energy CT of the breast for detection of breast cancer in the ipsilateral and contralateral breast compared to standard multihance breast MR imaging.

To determine the optimal workflow and images needed multiplanar reconstructions, color maps, etc. The purpose of this study is to collect blood and tissue samples for research of cancer.

Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Implant-based breast reconstruction is frequently achieved in two-stages.

The first stage consists of the placement of a tissue expander after mastectomy. This is followed by a period of weekly tissue expansions that can last several months. In the second stage, the tissue expander is removed in a surgical procedure and replaced with a permanent breast implant. Tissue expansion is a well-established breast reconstruction technique characterized by high success rates and Collection of tissue and blood from patients with residual disease after neoadjuvant systemic therapy for breast cancer.

We hope to use these samples to find out why some patients still have cancer after they have completed neoadjuvant anticancer therapy. The purpose of this study is to determine the overall prevalence and types of germline genetic mutations in a contemporary multi-institutional cohort of women diagnosed with a phyllodes connective tissue tumor of the breast, to compare the overall rate and types of germline genetic mutations observed in a multi-institutional cohort of women with phyllodes tumors to the average population and women with breast cancer, and to compare the rate and types of germline genetic mutations identified between each of the histologic subtypes grade of phyllodes tumors benign, borderline, malignant.

The purposes of this study are to evaluate whether pre-NAC peripheral blood immune phenotypes defined by mass cytometry are associated with pathologic complete response pCR after neoadjuvant chemotherapy in patients with operable breast cancer, and to evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls.

The purpose of this study is to utilize the systematic application of transcriptome-wide microarray to measure differential gene expression in banked breast implant associated-anaplastic large cell lymphoma BIA-ALCL tumor specimens and healthy control tissue.

The purpose of this study is to assess genetic predictors of chemotherapy-related amenorrhea in breast cancer survivors of both European and non-European ancestry. The short-term goal of the proposed research is to develop a new method for viscoelasticity imaging of breast that can work with any type of wave, and not restricted to plane shear waves. The long-term goal of this project is to develop an ultrasound-based breast imaging technique to improve the diagnostic specificity in breast cancer.

If so, patients can undergo US guided biopsy which is more comfortable for patients and more cost effective. The purpose of this study is to evaluate the accuracy of diagnosis with contrast enhanced digital mammography when used in addition to standard mammography or ultrasound in patients with suspicious findings. The purpose of this research study is to understand the views and experiences of African American women with a diagnosis or who support a family member with breast or ovarian cancer.

We also want to know participant thoughts on genetic testing for cancer risk. Connect BreastCancerTrials. Site Map Find a Trial. What You'll Need. Making your Decision. See All Trials. Personal Stories. BCT for Researchers. BCT for Care Providers. FDA Resources. Arms and Interventions. Radiation therapy will be given once a day.

Outcome Measures. Primary Outcome Measures : Determination of the rates of acute and late toxicities acute and late adverse events resulting from proton therapy radiation treatment. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Must sign study-specific, IRB approved informed consent form prior to study entry.

Note consent by legally authorized representative is not allowed for this trial. Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer. Must have pathology proven breast cancer. Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted. Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.

Exclusion Criteria: Weight over pounds. Non-epithelial breast malignancies such as sarcoma or lymphoma. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. If surgical margins are rendered free of disease by re-excision, the patient is eligible. Breast size exceeding the technical limitation of daily set-up reproducibility.