Breast Cancer

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Clinical Trials for Breast CancerGeneral Purpose:

Breast cancer is one of the most common and well-known cancers affecting women (and some men) today. Over 225,000 women in the United States, and 2,100 men, will be diagnosed with breast cancer during 2012. Fortunately, there are many effective therapies and clinical trials for breast cancer, which means that patients can often be cured of their cancer if it is detected early enough.

However, new treatments are constantly being evaluated through clinical trials, in addition to research investigating the potential causes of breast cancer – including environmental exposures, genetic mutations, and behavioral characteristics such as diet and exercise.

What Will Clinical Trials for Breast Cancer Be Like?

When participating in a breast cancer clinical trial, there are a few basic tests and procedures you may receive; however, the ultimate design of the particular study will determine which specific procedures you will undergo. The following tests and procedures are often used during breast cancer clinical trials:

  • Clinical breast exam during which your healthcare provider checks your breasts forClinical Trials for Breast Cancer lumps.
  • Mammogram
  • Ultrasound
    • Computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI). CT scans and MRI enable doctors to view more detailed pictures of areas inside your body than X-rays can reveal.
    • Biopsy
    • Blood tests to evaluate levels of hormones, proteins, and specific blood cells, and to look for various markers indicating response to investigational medication

Typical Protocol for Clinical Trials for Breast Cancer:

Clinical trials for breast cancer are plentiful and span a wide variety of topics, from symptom control, prevention, treatment, and improved screening. Possible examples include the following: 

  • Trials that compare the effectiveness of standard radiation therapy to the entire breast (following surgical removal of the breast tumor) with more targeted radiation therapy to a smaller area of the breast.
  • Clinical trials that evaluate the effectiveness of receiving chemotherapy prior to surgery to remove a breast tumor.
  • Clinical trials that assess certain lab tests to determine which, if any, can be useful to help predict how a woman will respond to a certain type of chemotherapy.
  • Clinical trials that investigate if hormone therapy administered prior to surgical removal of a breast tumor can help to shrink the size of the tumor and make it easier to remove.
  • Studies that investigate ways of improved control and treatment of side effects following surgery to remove breast tumors, such as treatments to reduce pain and improve overall quality of life.
  • Studies that involve the study of breast tumor tissue to better understand the genetic influences that play a role in the development of breast cancer.
  • Studies that investigate the effectiveness of alternative therapies, such as acupuncture or yoga, to help improve the side effects associated with breast cancer treatment, or to improve overall quality of life in breast cancer patients.

A brief word about randomized trials and placebos:

Clinical trials for breast cancer, as well as many other clinical trials involve the comparison of an investigational treatment to an existing or “standard” treatment for the cancer. The Clinical Trials for Breast Cancerexact therapy (i.e., investigational or standard) that each patient receives in such a trial is usually determined through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

Sometimes, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or sham treatments that are identical to the active treatment; however they have no therapeutic value.

The purpose for using a placebo is to be certain that any adverse effects that occur during the clinical trial are actually the result of the investigational treatment and not some other factor. In these types of trials, all patients receive the standard treatment, while those randomized to the investigational treatment receive the additional drug.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials, however, and is only done when it is necessary from a scientific standpoint, is ethically appropriate, and when patients have been adequately informed that they may receive the placebo.

Therefore, it is important to understand that if you are interested in participating in a trial that involves the use of a placebo alone (i.e., without standard treatment because none exists), you may end up receiving the placebo rather than the active treatment being investigated.

Often times, patients are reluctant to join a trial that involves the use of a placebo for fear that they will not receive an active treatment. While that may occasionally be the case, individuals who receive placebos are necessary to clinical research because their response during the study allow researchers to better measure the effects of the active treatment being studied, and help the researchers observe what would have happened without the active treatment.

It is also important to understand that it is not appropriate for an individual to participate in a placebo-controlled trial when there is a widely available and highly effective standard treatment already in existence for their cancer.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on whether you have been newly diagnosed with cancer, or if you have already received treatment. In addition, Clinical Trials for Breast Cancereligibility may also be determined based on the stage of your cancer.

Therefore, it is important to know the exact details of your cancer diagnosis when searching for clinical trials for breast cancer. Specific details you will want to make note of and have on hand include the following:

  • The official name of your cancer (e.g., ductal carcinoma in situ of the breast)
  • Knowledge of where your cancer first started. For example, if you have breast cancer that spread to the liver, it is still considered breast cancer.
  • Know your cancer’s cell type. This information can be located in your pathology report.
  • Know the size and location of your tumor.
  • Know the locations of any and all metastases that have been diagnosed.
  • Know the stage of your cancer. This describes the extent of your cancer, and whether it has spread to other sites in the body. Each individual cancer has its own staging system, so be sure to know and understand the staging system specific to breast cancer.
  • Know your prior history of cancer (e.g., if you were diagnosed with skin cancer prior to your diagnosis of breast cancer, be sure to have all the details pertaining to that diagnosis as well).
  • Know your current performance status, which is an assessment performed by your doctor to determine how well you are able to perform normal activities of daily living. Two common scales used to evaluate the performance of cancer patients include the Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know what treatments you have already received for your cancer. Examples might include chemotherapy, radiation therapy, hormone therapy, and/or surgery.
  • Know your bone marrow function test results, including your white blood cell count, platelet count, and hemoglobin/hematocrit.
  • Know your liver function test results, including bilirubin and transaminases.
  • Know your kidney function (also referred to as renal function) test result, which includes serum creatinine.

Suggested Search Terms:

“breast cancer treatment,” “breast cancer recurrence,” “breast cancer screening,” “breast cancer chemotherapy,” “breast cancer radiation therapy,” “breast cancer alternative therapy,” “breast cancer quality of life,” and “male breast cancer.” “clinical trials for breast cancer”

Current Search Term:

“Breast Cancer”

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A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy

Conditions:   Metastatic Breast Cancer;   Breast Cancer
Interventions:   Drug: Entinostat;   Drug: Capecitabine
Sponsors:   University of Virginia;   Syndax Pharmaceuticals
Not yet recruiting

Understanding Barriers to Initiation and Adherence to Endocrine Therapy in Young Breast Cancer Survivors of Diverse Backgrounds

Condition:   Breast Cancer
Intervention:   Other: Phone interview
Sponsors:   Dana-Farber Cancer Institute;   National Cancer Institute (NCI)
Not yet recruiting

Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer

Condition:   Breast Cancer
Interventions:   Drug: Carboplatin;   Drug: Nivolumab
Sponsors:   Dana-Farber Cancer Institute;   Bristol-Myers Squibb

The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer

Condition:   Breast Cancer
Interventions:   Drug: Vinorelbine;   Drug: Trastuzumab;   Drug: Avelumab;   Drug: Utomilumab
Sponsors:   Ian E. Krop, MD, PhD;   Pfizer;   Breast Cancer Research Foundation;   Johns Hopkins University
Not yet recruiting

Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

Condition:   Breast Cancer
Intervention:   Radiation: hypofractionated partial breast irradiation
Sponsor:   Fudan University

Feasibility of an Individualized Goals of Care Discussion Guide for Advanced Breast Cancer

Condition:   Breast Cancer
Intervention:   Other: IGCDG
Sponsors:   Massachusetts General Hospital;   Pfizer
Not yet recruiting

Preoperative Accelerated Partial Breast Irradiation for Triple Negative Breast Cancer Using Proton Beam Scanning

Condition:   Breast Cancer
Interventions:   Radiation: Accelerated Partial Breast Irradiation;   Device: AlignRT
Sponsors:   Massachusetts General Hospital;   Federal Share Core;   National Cancer Institute (NCI)

A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer

Condition:   Breast Cancer
Interventions:   Drug: Nivolumab;   Drug: Cabozantinib
Sponsors:   Dana-Farber Cancer Institute;   Bristol-Myers Squibb;   Exelixis

Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

Condition:   Breast Cancer
Interventions:   Drug: Neratinib;   Drug: Fulvestrant
Sponsors:   Dana-Farber Cancer Institute;   Puma Biotechnology, Inc.

CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer

Condition:   Breast Cancer
Interventions:   Drug: Ribociclib;   Other: Endocrine therapy
Sponsors:   Massachusetts General Hospital;   Novartis

Rehabilitation After Breast Cancer

Condition:   Breast Cancer
Intervention:   Behavioral: Individually tailored nurse navigation
Sponsors:   Danish Cancer Society;   Rigshospitalet, Denmark;   Copenhagen University Hospital at Herlev

Safety and Efficiency of γδ T Cell Against Breast Cancer

Condition:   Breast Cancer
Interventions:   Procedure: Cryosurgery , IRE surgery ,surgery;   Biological: γδ T cells;   Other: γδ T cells/ Surgery
Sponsors:   Fuda Cancer Hospital, Guangzhou;   Jinan University Guangzhou

Breast Cancer Risk Assessment in Women Aged 40-49

Condition:   Breast Cancer
Intervention:   Other: Breast cancer risk report
Sponsor:   Beth Israel Deaconess Medical Center

Effect of Interval Cancer and Screening Process on Survival and Disease-free Period in Breast Cancer

Condition:   Breast Cancer
Interventions:   Procedure: Mode of detection: Cancer detected at screening;   Procedure: Mode of detection: Interval cancer
Sponsors:   Parc de Salut Mar;   Fondo de Investigacion Sanitaria;   European Regional Development Fund;   Red de Investigación en Servicios de Salud y Enfermedades Crónicas (REDISSEC)

A Randomized Phase II Study Of Eribulin Mesylate With or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer

Condition:   Breast Cancer
Interventions:   Drug: Eribulin Mesylate;   Drug: Pembrolizumab
Sponsors:   Dana-Farber Cancer Institute;   Merck Sharp & Dohme Corp.

A Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer

Condition:   Breast Cancer
Interventions:   Drug: Pembrolizumab;   Drug: Nab-Paclitaxel;   Procedure: Biopsy
Sponsors:   Dana-Farber Cancer Institute;   Merck Sharp & Dohme Corp.

Supine MRI in Breast Cancer Patients Receiving Neoadjuvant Therapy

Condition:   Breast Cancer
Interventions:   Device: Supine MRI;   Other: Neoadjuvant Therapy;   Device: Ultrasound;   Device: Mammography;   Procedure: Standard of Care
Sponsor:   Dana-Farber Cancer Institute
Not yet recruiting

Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer

Condition:   Breast Cancer
Intervention:   Drug: Fulvestrant with Enzalutamide
Sponsors:   University of Colorado, Denver;   United States Department of Defense

MyHealth: Follow-up After Breast Cancer Treatment

Condition:   Breast Cancer
Intervention:   Behavioral: MyHealth
Sponsors:   Danish Cancer Society;   Region Sjælland

Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy

Condition:   Breast Cancer
Interventions:   Device: nonlinear microscopy imaging of excised surgical margins;   Procedure: standard lumpectomy without nonlinear microscopy imaging
Sponsors:   Dana-Farber Cancer Institute;   Massachusetts Institute of Technology
Not yet recruiting

The LightPathTM Breast Cancer Study

Condition:   Breast Cancer
Intervention:   Device: LightPath™ Imaging System.
Sponsors:   Lightpoint Medical Limited;   European Commission

Improved Breast Cancer Therapy (I-BCT-1) in the Neoadjuvant and Metastatic Setting

Condition:   Breast Cancer
Interventions:   Drug: Carboplatin;   Drug: Paclitaxel
Sponsor:   Oslo University Hospital

Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics

Condition:   Breast Cancer
Interventions:   Radiation: Radiation Therapy (RT);   Drug: Capecitabine;   Drug: Trastuzumab;   Drug: Paclitaxel
Sponsor:   New York University School of Medicine

Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer

Condition:   Breast Cancer
Interventions:   Other: MRI;   Other: CESM
Sponsors:   Beth Israel Deaconess Medical Center;   GE Healthcare
Active, not recruiting

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