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Stage I-III Breast Cancer -- Triple Negative

Last updated: July 30, 2015


Chemotherapy

Chemotherapy Before Surgery for Stage III, HER2-Negative Disease

Phase II Neoadjuvant Trial of Eribulin Followed by Dose Dense Doxorubicin and Cyclophosphamide for Her2-negative, Locally Advanced Breast Cancer (NCT01498588)

Summary

Previous studies have shown that giving chemotherapy before surgery, called neoadjuvant treatment, is as effective as giving it after surgery. However, receiving chemotherapy first may shrink the tumor, allowing the patient to have less extensive surgery. It also allows researchers to study how the tumor responds to chemotherapy. The purpose of this study is to evaluate the effectiveness of a new chemotherapy regimen that combines eribulin (Halaven®), which is currently approved for use in treating metastatic breast cancer, followed by the neoadjuvant standard of care -- doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®). To be eligible, participants must have locally advanced (stage III) HER2-negative disease.
This is a Phase II trial

Taxol/Abraxane & Radiation at the Same Time for Locally Advanced Breast Cancer

Response, Resistance and Metastasis of Locally Advanced Breast Cancer (LABC, Stage 2B-3C) in a Multiethnic Cohort: A Phase II International Multicentric Study of Concurrent Paclitaxel and Radiation (NCT02280252)

Summary

The term locally advanced breast cancer commonly includes tumors whose maximum diameter is 5 cm (T3) or larger, or that have spread to the chest wall or skin. Researchers are trying to determine the best way to treat these patients. Paclitaxel (Taxol®, Abraxane®) is a chemotherapy drug routinely used to treat breast cancer. This study is investigating the effectiveness of giving Taxol or Abraxane and radiation at the same time to treat locally advanced breast cancer. To be eligible, a woman must have locally-advanced breast cancer (stage IIB, IIIA, or IIIB). Metastatic patients are limited to those with an intact breast, a locally advanced tumor, and involved ipsilateral supraclavicular node.
This is a Phase II trial

Taxol® and Cytoxan® after Surgery for Stage I and II Disease

A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Patients (NCT01106898)

Summary

Researchers are investigating whether there may be more effective ways of combining the chemotherapy treatments currently being used in the adjuvant (after surgery) setting. The chemotherapy drugs cyclophosphamide (Cytoxan®) and paclitaxel (Taxol®), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab (Herceptin®) with this chemotherapy regimen to individuals with HER2+ tumors may be an effective treatment. The goal of this study is to determine the effectiveness of the combination of the standard chemotherapy drugs cyclophosphamide and paclitaxel (and Herceptin for those with HER2+ tumors) after surgery for Stage I or II breast cancer.
This is a Phase II trial

Taxotere and Paraplatin Before Surgery in ER-, HER2- Stage II-III Breast Cancer

A Co-clinical Trial in Triple Negative Breast Cancer Patients With Genoproteomic Discovery (NCT02124902)

Summary

Researchers are trying to determine the best treatments for triple negative (ER-, PR-, HER2-) breast cancer. Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat advanced breast cancer. Carboplatin (Paraplatin®) is a chemotherapy drug used to treat advanced breast cancer that has not responded to previous chemotherapy treatments. This study is looking at the effect that Taxotere and Paraplatin have on cancer cells when they are given before surgery to treat patients with stage II or stage III triple-negative breast cancer.
This is a Phase II trial

Neoadjuvant Metronomic Chemotherapy for Stage II-III Triple Negative Breast Cancer

Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer (NCT00542191)

Summary

Metronomic chemotherapy is new approach to treatment that involves giving very low doses of chemotherapy over a longer period of time. There is evidence that metronomic chemotherapy can slow tumor blood vessel growth and produce fewer side effects than standard high-dose chemotherapy. Research has also shown it to be effective in tumors that have not responded to standard treatment. Given the limited options available for women with hormone-negative and HER2-negative breast cancer, researchers are studying the effectiveness of metronomic chemotherapy before surgery in women with triple-negative disease.
This is a Phase II trial

Cisplatin vs. AC Before Surgery in Patients w/ a BRCA Mutation

A Randomized Phase II Trial of Neoadjuvant Cisplatin vs. Doxorubicin/Cyclophosphamide (AC) in Women With Newly Diagnosed Breast Cancer and Germline BrCa Mutations (NCT01670500)

Summary

Women and men who are born with a BRCA1 or BRCA2 genetic mutation are at increased risk of developing breast cancer. Cisplatin is a platinum-containing chemotherapy drug that is used alone or in combination with other drugs to treat ovarian, bladder, and testicular cancers; it is sometimes used to treat other types of cancer as well. It is not FDA approved to treat breast cancer. Doxorubicin (Adriamycin®) and cyclophosphamide--known as AC--is routinely used to treat breast cancer. Giving chemotherapy in the neoadjuvant (before surgery) setting allows researchers to study how the tumor responds to the treatment regimen. It can also shrink the tumor, potentially allowing a patient to have a lumpectomy instead of a mastectomy. This study is comparing cisplatin to AC in BRCA+ women and men with newly diagnosed breast cancer.
This is a Phase II trial

Neoadjuvant Chemotherapy for Stage II or III Breast Cancer

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin+Nab-Paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting (NCT00618657)

Summary

Individuals with Stage II or III breast cancer may not be candidates for breast conservation surgery (lumpectomy) if their tumors are too large. As an alternative to mastectomy, chemotherapy may be given prior to surgery (neoadjuvant chemotherapy) in order to shrink the tumor so it can be removed by breast conservation surgery. This trial will evaluate the benefits of giving neoajduvant chemotherapy with carboplatin (Paraplatin®) and nab-paclitaxel (Abraxane®) in combination with trastuzumab (Herceptin®) for HER2-positive breast cancer or bevacizumab (Avastin®) for HER2-negative disease, before surgery in women with Stage II or III breast cancer.
This is a Phase II trial

Capecitabine & Paclitaxel Before Surgery in Stage II-III Cancer

Capecitabine and Paclitaxel (Albumin-Stabilized Nanoparticle Formulation) in Treating Women Undergoing Surgery for Stage II or Stage III Breast Cancer (NCT00397761)

Summary

Chemotherapy drugs work in different ways to stop the growth of tumor cells. Giving two drugs (combination chemotherapy) that work in different ways before surgery may shrink the tumor and reduce the amount of normal tissue that needs to be removed. Capecitabine (Xeloda®) is an oral chemotherapy drug used to treat metastatic breast cancer. Upon reaching a cancer cell, the drug is converted by the body into the chemotherapy drug 5-fluorouracil (5FU). Paclitaxel (albumin-stablized nanoparticle formulation) (Abraxane®) works in a different way than 5FU to stop tumor cells from growing. It is routinely used to treat early-stage and advanced breast cancer. The goal of this trial is to evaluate the safety and effectiveness of using the combination of capecitabine and paclitaxel as neoadjuvant treatment in women with stage II-III breast cancer.
This is a Phase II-III trial

Treatment and Tissue Collection Before Surgery in Patients With Stage II-III Breast Cancer

Prospective Tissue Collection in Breast Cancer Patients Receiving Preoperative Systemic Therapy (NCT01897441)

Summary

Giving treatment before surgery—called neoadjuvant therapy—allows researchers to study the effect that the cancer drugs have on the breast tumor. Collecting and storing samples of tissue from breast cancer patients for laboratory research may help scientists learn which tumors respond best to certain treatments. This trial is collecting and storing tissue from patients with stage II-III breast cancer who have been given one of three different treatment combinations prior to surgery.

Chemo After Neoaduvant Chemo and Surgery for Basal-Like Triple-Negative Breast Cancer

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy (NCT02445391)

Summary

Most triple-negative breast cancers have basal-like qualities, meaning the cells resemble the basal cells that line the breast ducts. Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor before surgery. Sometimes the tumor will disappear completely. In other instances, the tumor can be seen during surgery. Cisplatin (Platinol®) and carboplatin (Paraplatin®) are platinum-based chemotherapy drugs that laboratory studies suggest may be effective against basal-like triple-negative breast cancer. This study will investigate whether giving one of these chemotherapy drugs after surgery reduces the risk of recurrence in patients with basal-like triple negative breast cancer who had neoadjuvant therapy that did not make their tumor disappear. Participants will have their tumor specimens tested for basal-like qualities.
This is a Phase III trial

Fasting Along with Treatment Given Before Surgery for Newly Diagnosed Breast Cancer

A Pilot Study of Short-term Fasting on Neoadjuvant Chemotherapy in Patients With Newly Diagnosed Breast Cancer (STEFNE Study) (NCT02379585)

Summary

Laboratory studies suggest that fasting (not eating for a short term) can help protect normal cells from the harmful side effects of chemotherapy. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study the effect that the treatment has on the cancer cells. Researchers think that having patients fast before and after receiving neoadjuvant therapy may help reduce side effects. This study is looking at the safety and the effect that having patients fast before and after they receive neoadjuvant therapy has on the tumor. HER-2 negative patients will receive the breast cancer chemotherapy regimen (doxorubicin/Adriamycin® and cyclophosphamide/Cytoxan® followed by paclitaxel/Taxol®). HER2+ patients will receive the breast cancer regimen chemotherapy (docetaxel//Taxotere®) along with the HER2- targeted therapies (trastuzumab/Herceptin® and pertuzumab/Perjeta®) followed by pegfilgrastim/Neulasta® and docetaxel/Taxotere®.
This is a Phase I-II trial

Propranolol & Chemo Before Surgery for Stage I-II Breast Cancer

A Phase II Study of the Beta-blocker Propranolol Alone and With Chemotherapy in Patients Receiving Neoadjuvant Treatment for Newly Diagnosed Breast Cancer (NCT01847001)

Summary

Propranolol (inderal®) is an FDA-approved drug used to treat high blood pressure, heart failure, angina, anxiety, and migraine. Laboratory studies suggest that Inderal also blocks the growth of the blood vessels cancer cells need to survive. Giving chemotherapy before surgery (neoadjuvant therapy) allows researchers to study how cancer cells respond to a treatment. This study is exploring the effectiveness of and side effects associated with giving Inderal along with neoadjuvant chemotherapy to treat stage I or II breast cancer. To be eligible, a woman must be receiving AC (adriamycin and cyclophosphamide) or paclitaxel (Taxol®) with or without Trastuzumab (Herceptin®) chemotherapy before surgery.
This is a Phase II trial

Cisplatin vs. Paclitaxel Before Surgery for Triple Negative Breast Cancer

A Randomized Phase II Study of Preoperative Cisplatin Versus Paclitaxel in Patients With Triple Negative Breast Cancer Without Germline BRCA Mutations: Evaluating the Homologous Recombination Deficiency (HRD) Biomarker (NCT01982448)

Summary

Researchers are trying to determine the best drugs for treating triple negative breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that cancer drugs have on tumor cells. Cisplatin (Platinol®) is a chemotherapy drug used to treat other types of cancers that laboratory studies suggest may be effective against triple negative breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug that is routinely used to treat breast cancer. The HRD (Homologous Recombination Deficiency) assay is a tumor test that researchers think can predict if the tumor will respond to a specific type of chemotherapy. This study is comparing the effect that Platinol and and Taxol have on triple negative breast tumors when it is given before surgery. The study is also looking at whether the HRD assay can predict if the tumor will respond to the treatment.
This is a Phase II trial

Surgery

Nipple-Sparing Mastectomy

Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy (NCT01002014)

Summary

Many women choose to have a skin-sparing mastectomy when they have immediate breast reconstruction. During a traditional skin-sparing mastectomy, all of the breast skin is preserved, except for the nipple and areola. Nipple-sparing mastectomy is a procedure that allows women to keep their nipple and areola as well. The goal of this study is to observe the cosmetic outcomes, patient satisfaction, and complications of nipple-sparing mastectomy. To be eligible, women must be planning to have either a therapeutic or prophylactic mastectomy.

Breast-Conserving Surgery to Treat Multiple Breast Tumors

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer (NCT01556243)

Summary

Early data suggest that one reason the mastectomy rate is increasing is due to the increased identification of multiple ipsilateral breast cancers (MIBC)—more than one tumor in the same breast. This may be because of the perceived belief that women with MIBC are at greater risk of having a local recurrence. The purpose of this study is to assess the local recurrence (LR) rate that occurs after breast conserving surgery (lumpectomy) is performed in patients with MIBC. To be eligible, participants must have two or three foci of biopsy-proven breast cancer in no more than two quadrants of the breast.
This is a Phase II trial

A New Way to Assess Tumor Margins During Surgery

A Phase 0/1, Open-Label, Single Center Study of the Imaging Potential of Indocyanine Green in Subject Undergoing Breast Cancer Surgery (NCT01796041)

Summary

Studies suggest that up to 70 percent of women who choose to have a lumpectomy need a second operation (a re-excision) because the initial surgery did not result in a clean margin--an area around the tumor that is cancer-free. Currently surgeons feel the breast tissue to determine whether they have obtained a clean margin. This trial is looking at whether an imaging technique that can be performed during surgery makes it easier to identify tumor margins and decreases the need for a second operation. To be eligible, participants must be planning on having a lumpectomy.
This is a Phase O trial

Cryoablation (Freezing) Instead of Surgery & Radiation for Older Women with Small Tumors

Freezing Alone Instead of Resection and Radiotherapy Of Small Breast Tumors: A Study of Cryoablation in the Management of Prognostically Favorable Early Stage Breast Cancer in Elderly Women (NCT01992250)

Summary

Cryoablation uses extreme cold to destroy cancerous tumors. The procedure involves using an ultrasound to pass a thin metal probe through the center of the tumor and then cooling the probe to an extremely low temperatures (-276°F) to freeze and kill the breast tumor. The procedure does not leave any significant scarring. The researchers believe that cryoablation can successfully destroy a small tumor (no greater than 2.0 cm). This study is looking at how well cryoablation works to prevent local recurrence in women 70 and older who would have otherwise had surgery and radiation to treat an early-stage invasive breast cancer. To be eligible for this study, a woman must have a tumor that is classified as Luminal A on a core needle biopsy.

Reducing Post-Operative Pain From Breast Reconstruction

A Prospective Randomized Double Blind Trial to Reduce Post-Operative Pain in Implant Based Breast Reconstruction (NCT02044302)

Summary

Opioids and sedatives like diazepam (valium) are the drugs typically used to manage pain in women who are having a mastectomy with breast reconstruction. Opioids are effective, but they can cause side effects like nausea, vomiting, sedation, and constipation. Bupivacaine is a local anesthetic. Botulinum toxin (commonly known as Botox) is a muscle relaxant. Both block the nerve impulses that send pain signals to the brain. This study is investigating whether using bupivacaine and Botox, either alone or together, during surgery will provide better pain control post-surgery and reduce incidences of opioid side effects in women who are having a mastectomy with breast reconstruction.
This is a Phase II trial

Regional Anesthesia and Breast Cancer Recurrence

Regional Anesthesia and Breast Cancer Recurrence (NCT00418457)

Summary

Surgery is the primary and most effective breast cancer treatment. The goal of surgery is to remove all of the cancer. However, scattered micrometastases and/or a few tumor cells are almost always missed. While a variety of factors determine whether a woman will go on to have a breast cancer recurrence, recent animal and human studies suggest that replacing general anesthesia/analgesia with regional anesthesia/analgesia results in a lower incidence of breast cancer metastases. This trial will help determine whether the risk of recurrence differs between women who receive regional anesthesia/analgesia compared to those who receive general anesthesia/analgesia.
This is a Phase III trial

Reducing Mastectomy-Related Pain

Pain After Tumescent Mastectomy or Standard Mastectomy in Women With Stage I, Stage II, or Stage III Breast Cancer (NCT00859157)

Summary

Post-operative mastectomy pain is a routine occurrence in women being treated for breast cancer. Tumescent mastectomy is a new surgical technique that involves use of a local anesthesia instead of a general anesthesia. The local anesthesia causes the breast to swell during surgery, which may reduce post-operative pain. The goal of this trial is to compare pain experienced by patients who receive a tumescent mastectomy with that of patients who receive a standard mastectomy. To be eligible, patients must be planning on having a mastectomy without immediate breast reconstruction.

Surgery: Reconstruction

Meso BioMatrix Device for Breast Reconstruction

Meso BioMatrix Acellular Peritoneum Matrix Breast Reconstruction Feasibility Trial (NCT01823107)

Summary

Breast reconstruction after mastectomy is often a two-stage process that starts with the insertion of a tissue expander to gradually stretch the skin and underlying muscle of the breast. Surgeons have recently begun using a mesh derived from human cadaver skin to create a pocket for the tissue expander. The Meso BioMatrix Acellular Peritoneum Matrix is a new mesh that is similar to human skin and recently cleared by the FDA. This is a feasibility trial—a small study to evaluate how this mesh performs during breast reconstruction. The results of this trial, if successful, may be used to design a larger clinical trial in the future.
This is a Phase I-II trial

A Study of Two Types of Mesh That May Improve Breast Reconstruction

Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction: A Blinded, Prospective, Randomized, Controlled Trial (NCT01310075)

Summary

Breast reconstruction with implants is often a two-stage process that starts with the insertion of a tissue expander to gradually stretch the skin and underlying muscle of the breast. During the second surgery, the expander is replaced with an implant(s). Researchers are studying new absorbable mesh products that can be used to support a breast implant as the tissue around it heals. The mesh may help reduce complications and improve appearance. AlloDerm® and SurgiMed® are two absorbable mesh products. AlloDerm is made with human cadaver skin. SurgiMed is made with calve skin. This study is comparing the appearance and rate of complication of breast reconstruction surgeries that use one of these mesh products with surgeries that do not use mesh. To be eligible, a patient must be scheduled to have a skin-sparing mastectomy with any of the surgeon co-investigators eligible for the study.

Radiation oncology

HylaCare™ Cream to Reduce Side Effects from Radiation Therapy

Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast. (NCT02165605)

Summary

Radiation is commonly used after a lumpectomy to kill any cancer cells that may remain in the breast. Its side effects include skin changes such as redness, dryness, swelling, and peeling. HylaCare™ (hyaluronic acid-containing topical cream) is a cream that may be able to reduce these side effects. This study will compare the effectiveness of HylaCare™ to a placebo for treating skin changes caused by radiation therapy in women being treated for breast cancer. To be eligible, a woman must have plans to receive external beam radiation and not currently be using other skin care creams on her breast.

Melatonin to Reduce Fatigue Caused by Radiation Therapy

Melatonin Supplementation for Cancer-related Fatigue in Patients Receiving Radiotherapy: A Double Blind Placebo-Controlled Trial (NCT02332928)

Summary

Fatigue is a common side effect of radiation therapy. Melatonin is a hormone made naturally by the body that helps regulate sleep and wake cycles. Researchers think giving melatonin supplements to women before, during, and after their radiation therapy may help reduce fatigue. This study is comparing the effectiveness of melatonin supplements to a placebo in women receiving radiation as part of their breast cancer treatment.
This is a Phase III trial

Single Dose Radiation for DCIS or Early-Stage Breast Cancer

Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer (NCT01754519)

Summary

The standard treatment for ductal carcinoma in situ (DCIS) and early-stage breast cancer is lumpectomy (breast conserving surgery) followed by breast radiation. Radiation therapy uses high-energy x-rays to kill tumor cells that may be left behind following surgery. Single fraction radiation therapy (SFRT) is a high dose of radiation that is given during surgery. This trial is studying the safety and effectiveness of using SFRT during a lumpectomy surgery to treat post-menopausal women with DCIS or early-stage breast cancer.
This is a Phase II trial

Breast CT to Guide Radiation & Surgery After Neoadjuvant Chemo

Koning Breast CT (KBCT)-Guided Neoadjuvant Treatment of Breast Cancer Monitoring Phase I Trial (NCT01771497)

Summary

Giving chemotherapy or hormone therapy before breast cancer surgery--called neoadjuvant treatment--can shrink the breast tumor, which may allow less tissue to be removed during surgery. Breast CT scans takes 3D images of the breast that may make it easier for doctors to more accurately measure the size, volume, and density of breast tumors. This study is investigating whether using the Koning Breast CT to take images of the breast tumor during neoadjuvant treatment provides a more accurate assessment of the tumor's size and location and leads to improved surgical and radiation therapy outcomes.

Proton Radiation Therapy After Lumpectomy for Early-Stage Breast Cancer

Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors. (NCT01310530)

Summary

Proton beam therapy is a new type of radiation treatment that uses protons rather than x-rays to kill cancer cells. It is not more effective than x-ray radiation, but it does expose less healthy tissue to radiation. The standard treatment following a lumpectomy is whole breast radiation. However, studies have shown that partial breast radiation may be a viable alternative for some patients. The purpose of this trial is to determine the safety, effectiveness and side effects of partial breast radiation with proton therapy in patients with early stage breast cancer who have had a lumpectomy.
This is a Phase II trial

Partial-Breast Irradiation for DCIS or Stage I Breast Cancer

A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer (NCT01581619)

Summary

Ductal carcinoma in situ (DCIS) and early stage breast cancer are typically treated with surgery followed by radiation therapy. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer or pre-cancer was removed (called the "tumor bed"). PBI may reduce radiation related side effects as well as shorten the radiation treatment process because only part of the breast is being treated. It is not yet known whether PBI and WBI are equally effective for treating grades 1 or 2 DCIS or stage I breast cancer. The purpose of the study is to evaluate the safety of external-beam PBI in early breast cancer patients.
This is a Phase I trial

Intraoperative Radiation for Age 45 and Over with Early Stage Breast Cancer

A Prospective Single-Arm Phase II Study To Investigate The Efficacy Of Single-Fraction Intraoperative Radiation Treatment Using A Multi-Lumen Balloon Applicator And In-Room CT Imaging For The Treatment Of Early-Stage Breast Cancer (NCT02400658)

Summary

Breast conserving surgery (lumpectomy) followed by radiation therapy is a standard treatment for early-stage breast cancer. Intraoperative radiation therapy (IORT) delivers a high dose of radiation guided by CT-imaging during surgery to the area in the breast where the tumor was removed. This study is evaluating the effectiveness of IORT in women with early-stage breast cancer who are age 45 or older and have a tumor less than or equal to 3cm.
This is a Phase II trial

Intraoperative Radiation Therapy for Early Stage Breast Cancer

Intraoperative Radiotherapy (NCT01189851) for the Management of Carcinoma of the Breast: Use of Mammography, Ultrasonography,and Contrast-Enhanced Magnetic Resonance Imaging (CE-MRI) to Identify Candidates for NCT01189851 (NCT01189851)

Summary

It is typically recommended that women receive radiation therapy following a lumpectomy for breast cancer. This usually requires that a woman receive daily radiation treatments for 5-6 weeks. Intraoperative radiation therapy (IORT) is an intensive radiation treatment that delivers a concentrated beam of radiation to the tumor area during surgery. IORT allows direct radiation to the tumor while sparing normal surrounding tissue. The goal of this trial is to determine the safety and effectiveness of IORT when administered during surgery for Stage I or II breast cancer. To be eligible, participants must be planning to have a lumpectomy.

Cosmetic Results of Lumpectomy & Hypofractionated Radiation

Phase II Evaluation of Hypofractionated Breast Irradiation in Patients Undergoing Standard Lumpectomy or Oncolytic Mammoplasty With Bilateral Breast Reduction (NCT01400399)

Summary

Breast conservation surgery followed by radiation therapy is an established treatment for early stage breast cancer. Breast conservation surgery refers to either lumpectomy, or bilateral reduction mammoplasty (BRM). Lumpectomy involves removal of the tumor with a small amount of surrounding normal tissue. With BRM, a larger margin of normal tissue around the tumor is removed and the opposite breast is surgically reduced in size to maintain symmetry. All women in this study will have either lumpectomy or BRM followed by approximately 3 weeks of radiation treatment (hypofractionated). This data collection trial will evaluate the cosmetic outcome and factors contributing to cosmetic outcome in women treated with lumpectomy or BRM followed by hypofractionated radiation (larger doses (fractions) of radiation in fewer sessions over a shorter period of time). To be eligible participants must be at least 50 years old, diagnosed with DCIS or early stage breast cancer, with no lymph node involvement.

Internal Breast Radiation Therapy for Early-Stage Disease

A Natural History Study of Patients Receiving High Dose Rate Brachytherapy (NCT00924027) (NCT00924027)

Summary

Women with ductal carcinoma in situ (DCIS) and early-stage breast cancer are often treated with a lumpectomy (breast conserving surgery) followed by radiation therapy. Brachytherapy is a type of radiation treatment that delivers a high dose of radiation directly to the tumor area. Brachytherapy is delivered through small radioactive "seeds" that are put into a hollow device that has been placed inside the area of the breast where the DCIS or tumor was removed. Brachytherapy takes less time than traditional radiation therapy. It also reduces the amount of radiation healthy tissue receives. The goal of this study is to evaluate the quality of the brachytherapy procedure being used to treat women with DCIS or early-stage breast cancer at the National Institutes of Health's Radiation Oncology Branch.

Radiation Therapy During Surgery for Early-Stage Disease

Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT) (NCT01295723)

Summary

Radiation therapy is used following a lumpectomy to destroy any cancer cells that may be left in the breast after surgery. It usually consists of 3-5 weeks of daily whole breast radiation therapy, followed by a “boost” of 5-8 daily radiation treatments targeted directly to the site where the tumor was located. Intraoperative radiation therapy with electrons (IOERT) is a new technique that gives intensive radiation therapy during surgery to the area where the tumor was removed. The purpose of this study is to evaluate the safety and effectiveness of using IOERT in individuals with Stage I or II breast cancer who go on to receive three weeks of whole breast radiation therapy. To be eligible, participants must be planning to have a lumpectomy.

Breast Cup Immobilization During Radiation

Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II (NCT01704547)

Summary

Lumpectomy followed by radiation is the standard of care for treating early-stage breast cancers. The radiation treatment includes whole breast radiation followed by a boost directed at the site where the tumor was removed. The Breast Cup Immobilization Device (BCID) is similar to immobilization devices used when giving radiation therapy to cancers in other parts of the body. This study is looking at how well the BCID works to keep the breast in place during breast radiation. To be eligible, participants must be planning to have, or have had surgery and radiation therapy.

Proton Radiation Therapy After Mastectomy

Pilot Study of Proton Radiation Therapy for Invasive Breast Carcinoma Following Mastectomy (NCT01340495)

Summary

Radiation is sometimes given after a mastectomy to destroy any cancer cells that may have been left behind during surgery. This study is looking at a new type of radiation therapy called proton radiation. By delivering radiation more precisely, proton radiation is expected to reduce side effects as well as decrease the amount of radiation exposure to nearby healthy tissue. To be eligible, participants must have received a complete mastectomy and have been recommended to receive radiation therapy.

Cyberknife® Partial Breast Radiation for Early-Stage Disease

A Phase I Study of Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer (NCT01162200)

Summary

Radiation therapy is given after a lumpectomy to kill any cancer cells that may have been left behind after surgery. Currently, the standard of care is whole breast irradiation (WBI), which usually requires that a patient receive radiation therapy daily for 5-7 weeks. Many studies have shown that partial breast irradiation (PBI), in which the radiation is targeted to the lumpectomy area, can be just as effective as WBI with a much shorter treatment schedule. The CyberKnife® System is a new technology that can be used to deliver PBI in a more precise way to limit damage to surrounding healthy tissue. The purpose of this trial is to determine the best dose of radiation using the CyberKnife System for PBI, and to study the side effects and cosmetic outcomes in women who have undergone lumpectomy to treat breast cancer.
This is a Phase I trial

Nipple and Areola Radiation After Nipple-Sparing Mastectomy

A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer (NCT01208974)

Summary

In a nipple-sparing mastectomy all of the breast tissue is removed during surgery, except for the nipple and areola. Researchers believe that administering radiation therapy to the nipple and areola after a nipple-sparing mastectomy can reduce a patient's risk of having a breast cancer recurrence. The goal of this trial is to determine the effectiveness, toxicity, and cosmetic outcome of radiation to the nipple and areola in patients who are having a nipple-sparing mastectomy. The researchers will also be determining the radiation dose that should be used in future studies.
This is a Phase I trial

Image Guided Radiotherapy for Partial Breast Irradiation

Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI) (NCT02272400)

Summary

Studies now underway are comparing the effectiveness of whole breast radiation to partial breast radiation, which is given to the area of the breast where the cancer was removed. External partial breast irradiation (EB-PBI) is one method of providing partial breast radiation. Imaging technology is used during radiation to direct the radiation beam more accurately and to reduce radiation toxicity. Typically, a woman receiving breast radiation therapy is lying on her back. Prone breast radiation therapy is given to a woman lying on her stomach. This position may result in less damage to the heart and lungs. This study is looking at the effectiveness of using imaging technology along with EB-PBI in women lying in the prone position. To be eligible, a woman must be postmenopausal and have a small tumor (≤20 mm) that has not spread to the lymph nodes and that was removed with negative margins .
This is a Phase I-II trial

Single Fraction Intraoperative Radiotherapy

Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial (NCT01688388)

Summary

The standard treatment for early stage breast cancer is breast conserving surgery (lumpectomy) followed by breast radiation. The radiation treatment is typically given over three to five weeks followed by between five and eight daily radiation treatments that are focused on the site where the lump was removed. Researchers believe that giving this full radiation treatment during surgery may be equally effective. This study is evaluating the safety and effectiveness of giving this single dose of radiation during breast cancer surgery.
This is a Phase I-II trial

Proton Beam Partial Breast Radiation for Early Stage Disease

Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation (NCT01245712)

Summary

The standard treatment for early stage breast cancer is a lumpectomy followed by radiation to kill any cancer cells that may still remain in the breast. Radiation therapy is usually given 5 days a week for up to 7 weeks. Proton-beam partial breast irradiation (PBI) is a newer type of radiation therapy. It is given over a shorter time period, and it directs the radiation to the precise area of the breast where the cancer was removed so that less healthy tissue is affected. The goal of this study is to find out if a 1-week course of proton-beam PBI causes fewer or less severe side effects (such as changes to the breast's appearance) than a longer course of radiation treatment. To be eligible, women must be planning to undergo radiation, and have had or are planning to have a lumpectomy.
This is a Phase II trial

Concurrent Carboplatin & Radiation for Triple Negative Disease

Phase I-II Study of Concurrent Adjuvant Systemic Therapy and Accelerated Radiotherapy (Over 3 Weeks) (NCT01289353)

Summary

One standard treatment for stage I and II breast cancer is a lumpectomy, followed by radiation, followed by chemotherapy. Studies have found that giving radiation and chemotherapy at the same time (called chemoradiation) is an effective treatment for hormone receptor-negative (ER-negative and PR-negative) locally advanced breast cancer. The purpose of this study is to determine the safety and effectiveness of chemoradiation in patients with triple-negative breast cancer who have had breast cancer surgery. To be eligible, participants must have had or be planning to have a segmental (partial) mastectomy.
This is a Phase I-II trial

Three New Radiation Options Following Lumpectomy or Mastectomy

Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial (NCT00909909)

Summary

Ductal carcinoma in situ (DCIS) and early-stage breast cancer are often treated with a lumpectomy followed by radiation. Post-lumpectomy radiation usually involves whole breast radiation (WBI), followed by a radiation “boost” targeted directly to the site where the DCIS or early-stage cancer was located. Individuals who receive a mastectomy may also, in some cases, receive radiation therapy as well. These standard radiation treatments are usually given five days a week for up to seven weeks. Accelerated hypofractionated radiation involves giving larger doses (fractions) of radiation in fewer sessions over a shorter period of time. The goal of this trial is to study the effectiveness and side effects associated with three different accelerated radiation treatments in women with DCIS or early-stage breast cancer who have had or will be having a lumpectomy or mastectomy.
This is a Phase II trial

Proton Radiation for Stage III Breast Cancer

Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Women With Stage III,Loco-Regional, Non-Metastatic Breast Cancer (NCT01758445)

Summary

Radiation is often used following surgery to treat breast cancer. Standard X-ray radiation uses particles called photons to kill tumor cells. Proton therapy is an alternative type of radiation therapy that uses particles called protons instead of photons. Studies suggest that proton radiation may result in fewer side effects than traditional X-ray radiation. The purpose of this trial is to study the long-term effects of proton radiotherapy in women with locally advanced breast cancer.
This is a Phase II trial

A Low-Calorie Diet During Radiation for DCIS or Stage I Tumors

A Feasibility Pilot Trial Evaluating Caloric Restriction for Oncology Research in Early Stage Breast Cancer Patients (NCT01819233)

Summary

Laboratory studies suggest that a low-calorie diet can keep cancer cells from getting the blood glucose they need to survive. A low-calorie diet may also make it easier for radiation therapy to kill cancer cells. This pilot study is investigating whether it is possible to conduct a clinical trial on the effectiveness of combining a low-calorie diet and radiation. This study will also help the researchers identify the best way to assess the effect of the low-calorie diet. To be eligible, participants must be female, diagnosed with DCIS or stage I breast cancer, and scheduled to have a lumpectomy followed by radiation.

Naltrexone for Treating Fatigue That Develops During Radiation Therapy

Naltrexone Randomized Controlled Trial for Treatment-Emergent Fatigue in Patients Receiving Radiation Therapy for Breast Cancer (NCT02137252)

Summary

Fatigue is a common side effect of radiation therapy. Studies have shown that levels of beta-endorphins—a chemical the body makes in response to stress or injury—go up during radiation. An increase in beta-endorphins can cause fatigue. Naltrexone (ReVia®) is an FDA approved drug that interacts with beta-endorphins. Scientists think that naltrexone may help to reduce fatigue that develops in individuals undergoing radiation therapy. This study will compare naltrexone to a placebo in breast cancer patients who develop fatigue while undergoing radiation.
This is a Phase II trial

Dakin's Solution for Preventing Radiation Dermatitis During Breast Cancer Treatment

Pilot Study to Investigate the Impact of Hypochlorite in the Prevention of Radiation Dermatitis (NCT02203565)

Summary

Radiation dermatitis is a skin condition where the affected skin becomes painful, red, itchy, and blistered. Dakin's solution is a strong antiseptic that is commonly used to prevent and treat skin and tissue infections. Researchers believe Dakin's solution may help reduce radiation dermatitis. This study is evaluating whether applying Dakin's solution before radiation will prevent radiation dermatitis in women being treated for breast cancer. To be eligible, patients must be scheduled for radiation therapy to the breast or chest wall.

Breath Holding During Radiation Therapy to Protect the Heart

Prospective Pilot Study of Assessment of Breath Hold as a Means to Mitigate the Risk of Radiation-associated Reductions in Regional Cardiac Perfusion in Patients With Left-sided Breast Cancer (NCT01849614)

Summary

Breast cancer is often treated with a lumpectomy or mastectomy followed by radiation. Because the heart is so close to the left breast, radiation for left-sided breast cancer may increase a woman's risk of developing heart problems. Women who hold a deep breath while receiving radiation—a technique called Deep Inspiration Breath Hold (DIBH)—may be at less risk of developing future heart problems. This study is looking at whether DIBH reduces heart-related side effects. To be eligible, participants must have left-sided breast cancer and be planning to receive radiation therapy.

Intensity-Modulated Radiation Therapy After Lumpectomy

A Phase III Randomized Study Comparing Intensity Modulated Planning Versus 3-Dimensional Planning for Accelerated Partial Breast Radiotherapy (NCT01185132)

Summary

Women whose breast cancer is removed by lumpectomy almost always receive radiation after surgery. Intensity-modulated radiation therapy (IMRT) is a type of high-precision radiotherapy that delivers focused, high-dose radiation to the tumor, while reducing spread to the surrounding normal breast and lung tissue. The goal of this trial is to compare the effectiveness of intensity-modulated radiation therapy with standard radiation therapy. To be eligible, participants must have had or be planning to have a lumpectomy followed by radiation.
This is a Phase III trial

Lymph Node Dissection & Radiation after Neoadjuvant Therapy to Treat Positive Node(s)

A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy (NCT01901094)

Summary

Researchers are studying the best way to treat women who have received neoadjuvant therapy (treatment given before surgery) and are found to have a positive sentinel node(s) during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery. Axillary lymph node dissection (ALND) removes tumor cells that have spread to nearby lymph nodes or other nodes in the axillary (armpit) area. This study is comparing the effectiveness of ALND plus radiation therapy to radiation therapy alone in treating women who had neoadjuvant treatment and were found to have a positive sentinel node(s) during surgery.
This is a Phase III trial

Radiation for Women with Stage I-III Disease Who Had Chemo Before Surgery

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant... (NCT01872975)

Summary

Chemotherapy given before surgery (neoadjuvant treatment) can kill cancer cells in the lymph nodes. This means a woman who is initially node positive may be node negative at the time of surgery. The standard of care for women with early-stage breast cancer who have a lumpectomy is whole-breast radiation. Women who have a mastectomy typically do not receive radiation. Giving radiation to the lymph nodes following a lumpectomy and giving radiation to the chest wall and lymph nodes following a mastectomy may be more effective in women who become node negative after neoadjuvant chemotherapy. This study is enrolling women whose lymph node status changed from positive to negative after neoaduvant chemotherapy to see if additional radiation after surgery will reduce the risk of recurrence.
This is a Phase III trial

Breath Holding to Protect Heart and Lungs During Left-Breast Radiotherapy

Pilot Study For Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy (NCT02379988)

Summary

Women with breast cancer in their left breast who are treated with radiation have an increased risk of developing radiation-induced heart and lung problems. Deep Inspiration Breath Hold (DIBH), a technique where a woman holds a deep breath while receiving radiation, may help minimize radiation exposure to the heart and lungs. This study is investigating the effect of DIBH in patients receiving radiation for left sided breast cancer. To be eligible, participants must be a patient of Dr. Victor J. Gonzalez at the Arizona Cancer Center at University of Arizona Health Sciences Center.
This is a Phase O trial

Cisplatin & Radiation After Surgery for Triple Negative BC

A Phase I Dose-Escalation Study of Cisplatin and Radiation Therapy for Patients With Triple Negative Breast Cancer (NCT01674842)

Summary

New treatments for triple negative breast cancer are needed. Researchers believe that giving chemotherapy at the same time as radiation therapy to treat breast cancer may be more effective than using these treatments sequentially (one after another). Other types of cancers are currently treated this way. Cisplatin is a chemotherapy drug that works by preventing cancer cells from dividing and growing. It is not routinely used to treat breast cancer, but some studies suggest it may be particularly effective against triple negative tumors. Radiation is used to kill cancer cells that may have not been removed during surgery. The goal of this trial is to assess the safety, tolerability, and maximum tolerated dose of cisplatin when given at the same time as radiation to patients with triple negative breast cancer who have had or are planning to have a lumpectomy (breast conserving surgery).
This is a Phase I trial

Hormone therapy

The Effect of Oral Proellex on Breast Cancer Cells

Presurgical Phase IIB Trial of Oral CDB-4124 vs. Placebo in Women With Stage I-II Primary Breast Cancer (NCT01800422)

Summary

CDB-4124 (Proellex®) is a drug that blocks the progesterone receptor that may have a role in breast cancer treatment. Other clinical trials are currently under way that are studying whether it is effective in reducing symptoms associated with uterine fibroids and endometriosis. In this study, women with stage I or stage II tumors will be given Proellex or a placebo before surgery. The researchers will study the breast tissue removed during surgery to see how Proellex affected the breast cancer cells.
This is a Phase II trial

Targeted therapy

Radiation and Veliparib After Chemotherapy and Before Surgery

Pre-Operative PARPi and Irradiation (POPI) in Women With an Incomplete Response to Neo-Adjuvant Chemotherapy for Breast Cancer (NCT01618357)

Summary

Giving chemotherapy before surgery (called neoadjuvant therapy) allows doctors to see how the tumor responds to the treatment. It can also shrink the tumor, which may permit a woman to have a lumpectomy instead of a mastectomy. About 20-30 percent of the time, the breast tumor will completely disappear, making it less likely to recur. Veliparib is a type of new cancer treatment called a PARP inhibitor. Laboratory studies have shown that it can make the tumor more likely to respond to radiation and chemotherapy. This study is investigating the safety of combining radiation and Veliparib in women with stage II or III breast cancer whose tumors do not completely disappear after neoadjuvant chemotherapy.
This is a Phase I trial

Everolimus & Cisplatin after Neoadjuvant Chemo & Surgery for Triple-Negative Tumors

NEOADJUVANT PHASE II STUDY OF EVEROLIMUS PLUS CISPLATIN IN TRIPLE NEGATIVE BREAST CANCER PATIENTS WITH RESIDUAL DISEASE AFTER STANDARD CHEMOTHERAPY (NCT01931163)

Summary

Researchers are looking at the effectiveness of combining chemotherapy drugs with targeted therapies. Cisplatin (Platinol®) is a chemotherapy drug routinely used to treat breast cancer. Everolimus (Afinitor®) is a targeted therapy used to treat advanced hormone receptor-positive, HER2-negative breast cancer. This study is looking at the safety and effectiveness of using Platinol and Afinitor to treat patients with triple negative tumors who had chemotherapy before surgery (neoadjuvant treatment) that did not fully shrink the tumor.
This is a Phase II trial

BMN 673 Before Surgery for BRCA+ Patients with HER2-Negative Tumors

A Pilot Study of BMN673 as a Neoadjuvant Study in Patients With a Diagnosis of Invasive Breast Cancer and a Deleterious BRCA Mutation (NCT02282345)

Summary

Like normal cells, cancer cells replicate their DNA when they divide. The BRCA and PARP proteins help repair DNA that becomes damaged during cell division. In women with a BRCA mutation, cancer cells are unable to use the BRCA protein to repair damaged DNA and use the PARP protein instead. BMN 673 is a PARP inhibitor, a new type of cancer drug that kills cancer cells by blocking the PARP protein from fixing the damaged DNA. Giving therapy before surgery--called neoadjuvant treatment--allows researchers to study the effect that a cancer therapy has on the cancer cells. This study is evaluating the effect of BMN 673 when it is given before surgery to patients who have an inherited BRCA mutation and have tumors that are HER2-negative. To be eligible, a patient must have a breast tumor that is at least 1 cm in size.
This is a Phase II trial

Chemotherapy and a Targeted Therapy Before Surgery for Stage III Breast Cancer

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting (NCT02436993)

Summary

Stage II and III tumors are typically treated with chemotherapy before surgery. Carboplatin (Paraplatin®) and paclitaxel (Taxol®) are chemotherapy drugs routinely used to treat breast cancer. Bevacizumab (Avastin®) is a targeted therapy that keeps tumors from growing the blood vessels they need to survive. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2-positive breast cancer. In this study patients with HER2-negative tumors will receive chemotherapy and Avastin and patients with HER2-positive tumors will receive chemotherapy along with Herceptin and Perjeta. Researchers will evaluate the safety and efficacy of the two treatment protocols. They will also investigate whether magnetic resonance imaging (MRI) is a good tool for monitoring and predicting how the tumor will respond to the treatment.
This is a Phase II trial

Olaparib After Chemo for BRCA+ Triple Negative Stage I-III Breast Cancer

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With ... (NCT02032823)

Summary

Olaparib (Lynparaza) is a new type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. In tumor cells in women with a BRCA mutation, blocking this enzyme can lead to cell death. In Dec. 2014, Lynparza was approved for treating advanced ovarian cancer in women with a BRCA mutation. Prior studies suggest breast cancer that develops in patients with a BRCA mutation will also respond to Lynparza. This study is comparing the safety and effectiveness of Lynparza to a placebo in women with a BRCA mutation who have had surgery and neoadjuvant or adjuvant chemotherapy to treat early-stage triple-negative breast cancer.
This is a Phase III trial

Veliparib, Carboplatin & Chemo Before Surgery in Stage II-III Triple Negative Tumors

A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC) (NCT02032277)

Summary

Researchers are trying to develop the best treatments for triple negative breast cancer. Veliparib (ABT-88) blocks PARP, an enzyme that plays an important role in controlling cancer cell growth. Studies suggest it is effective in triple negative breast cancer. Carboplatin (Paraplatin®) is a chemotherapy drug that studies suggest is effective for triple negative breast cancer. TAC (Taxotere®, Adriamycin®/doxorubicin and cyclophosphamide®) is a chemotherapy regimen routinely used to treat breast cancer. Giving chemotherapy before surgery, called neoadjuvant therapy, allows researchers to study the effect that a drug combination has on breast cancer cells. This study is comparing the safety and effectiveness of three different treatment combinations–veliparib, Paraplatin and TAC; Paraplatin and TAC; and TAC—when they are given before surgery to patients with stage II or stage III triple negative breast cancer.
This is a Phase III trial

Chemotherapy & Herceptin Before Surgery for Stage I-III Tumors

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients With Breast Cancer (NCT01750073)

Summary

Giving chemotherapy before surgery may make the tumor smaller, reducing the amount of tissue that needs to be removed during surgery. It also allows researchers to study how tumors respond to certain drugs. Paclitaxel (Taxol®) and cyclophosphamide (Cytoxan®) are two chemotherapy drugs that are routinely used to treat breast cancer. Trastuzumab (Herceptin®) is a targeted therapy that is used to treat HER2-positive breast cancer. This trial is studying the effectiveness of, and the side effects that occur when, giving Taxol and Cytoxan to patients with stage I-III breast cancer. Patients with HER2+ tumors will also receive Herceptin prior to surgery, so that the researchers can study a three drug combination—Taxol, Cytoxan, and Herceptin.
This is a Phase II trial

Laboratory-Treated T Cells and Chemotherapy Before Surgery

Laboratory-Treated T Cells After Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer Undergoing Surgery (NCT01147016)

Summary

T cells are a type of white blood cell that help the body to fight off infection. Researchers believe that removing a patient's T cells, activating them in a laboratory by coating them with specific antibodies, and then putting them back into the body can teach the T cells how to kill tumor cells. Neoadjuvant therapy—treatment delivered prior to surgery—allows researchers to observe whether a tumor responds to a specific drug combination. Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) followed by paclitaxel (Taxol®) is a standard chemotherapy regimen. The goal of this trial is to determine the effectiveness of giving this standard chemotherapy regimen and laboratory activated T-cells before surgery to women with stage II or III triple negative breast cancer.
This is a Phase II trial

Personalized Gene-Based Treatment For Triple Negative Breast Cancer

A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158 (NCT02101385)

Summary

Researchers are trying to determine the best treatment for triple negative breast cancer. DNA from tumor samples collected at the time of surgery may provide information about which breast cancer treatments will work best on a specific tumor. Participants will have their tumors analyzed for 12 biomarkers or pathways found in breast cancer cells. One group will receive treatment based on the results. The other women will receive the standard of care. This will allow the researchers to compare therapy designed for each individual's tumor to the standard of care. To be eligible, participants must have had (or are planning to have) chemotherapy followed by surgery for breast cancer.
This is a Phase II trial

Denosumab for Disseminated Tumor Cells in Early Stage Cancer

Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer (UCSF Protocol No. 117527) (NCT01545648)

Summary

Studies have found that women with early stage breast cancer who have disseminated tumor cells (DTC) in the bone marrow are at increased risk of recurrence and death. Tests to detect DTC in women with early stage breast cancer may be helpful in identifying higher risk patients who might benefit from intervention with targeted therapies. Denosumab is used to treat osteoporosis and bone metastases. The researchers think that it also may be able to decrease DTC levels in women with early stage breast cancer who have completed chemotherapy. The purpose of this study is to see whether denosumab can reduce levels of DTC in the bone marrow below a significant level. To be eligible, participants must have DTC in the bone marrow following chemotherapy.
This is a Phase II trial

Herceptin in HER2-Negative Stage II/III Breast Cancer w/ HER2+ Disseminated Tumor Cells

A Phase II Randomized Trial Evaluating the Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Bone Marrow Disseminated Tumor Cells (NCT01779050)

Summary

Breast cancer patients who are found to have tumor cells in their bone marrow (known as disseminated tumor cells or DTCs) are at greater risk of a recurrence than patients without DTCs. Trastuzumab (Herceptin®) is used to treat HER2-positive breast cancer. However, some patients with HER2-negative tumors may have HER2-positive DTCs and may benefit from Herceptin therapy. ACT (doxorubicin/adriamycin, cyclophosphamide and Taxol) is a chemotherapy regimen used to treat breast cancer. This trial is comparing the safety and effectiveness of using Herceptin with ACT to using ACT alone to treat patients with stage II-III HER2-negative breast cancer who have been shown to have HER2-positive DTCs in their bone marrow.
This is a Phase II trial

Digoxin in Newly Diagnosed Operable Breast Cancer

Digoxin as a Novel Inhibitor of Global Hypoxia Inducible Factor-1α (HIF-1α) Expression & Downstream Targets in Breast Cancer: DIG-HIF1 Pharmacodynamic Trial (NCT01763931)

Summary

Breast cancer cells grow in a low oxygen environment called hypoxia. The protein HIF-1 controls the amount of oxygen in the body's cells. Researchers think blocking HIF-1 may make it harder for breast cancer cells to grow. Digoxin is a drug that has been shown to block HIF-1 in lab studies. (It is currently used to help the heart work better and to control heart rate.) The purpose of this study is to learn what effects digoxin may have on breast tumors. This will be done by comparing tumor tissue from a woman's original biopsy with tumor tissue removed at the time of surgery, after she has been on digoxin for two weeks. The researchers will also compare biopsy and surgery tissue from women not given digoxin with that of the women who did take it.
This is a Phase II trial

Personalized Treatment Before Surgery: The I-SPY 2 Trial

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) (NCT01042379)

Summary

Targeted therapy is an active area of breast cancer research in which treatment is tailored to an individual's tumor type. The goal of this trial is to determine whether standard chemotherapy can be made more effective by adding investigational drugs that target specific tumor characteristics. All treatment will be given prior to surgery (neoadjuvant therapy), enabling researchers to directly evaluate how well the tumor is responding. The information that researchers gain from each participant will be used to help decide which treatments should be given to women who join the trial at a later date. By designing the trial in this way, researchers will learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics.
This is a Phase II trial

Ipatasertib and Taxol Before Surgery for Early-Stage Triple-Negative Breast Cancer

A PHASE II RANDOMIZED, DOUBLE-BLIND, STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR TO AKT, IN COMBINATION WITH PACLITAXEL AS NEOADJUVANT TREATMENT FOR PATIENTS WITH EARLY STAGE TRIPLE NEGATIVE BREAST CANCER (NCT02301988)

Summary

Scientists are trying to develop new drugs that will be effective for patients with triple-negative breast cancer. Giving treatment before surgery, called neoadjuvant therapy, allows researchers to study the effect that the treatment has on cancer cells. Ipatasertib (GDC-0068) is a new type of targeted cancer therapy called an AKt inhibitor. It blocks a pathway inside the cell that regulates the cell's growth and survival. Early studies suggest that ipatasertib may be effective in patients with triple-negative breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug that is used to treat breast cancer. This study is comparing the effectiveness of Taxol and ipatasertib to Taxol and a placebo when it is given before surgery to patients with early-stage triple-negative breast cancer.
This is a Phase II trial

Vandetanib Before Surgery to Study Its Effect on Cancer Cells in Stage I-III Breast Tumors

A Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Effect of Vandetanib on Cellular Markers of Proliferation and Apoptosis in Invasive Breast Cancer (NCT01934335)

Summary

Giving treatment before surgery (called neoadjuvant therapy) allows researchers to study the effect that the treatment has on cancer cells. Vandetanib (Caprelsa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It is approved for treating thyroid cancer. Ki-67 is a protein in cells that increases as the cell prepares to divide into new cells. By measuring Ki67, researchers can learn how quickly the cancer calls are growing. This study is comparing the effect of Caprelsa and a placebo on Ki-67 (and other markers of tumor growth) when it is given before surgery to patients with stage I, II or III breast cancer. To be eligible, a patient must have had a core biopsy showing an invasive tumor and be scheduled to have surgery.

Response of Triple Negative Breast Cancer to Trametinib

Defining the Triple Negative Breast Cancer Kinome Response to GSK1120212 (NCT01467310)

Summary

Research are trying to develop cancer therapies that work by blocking the activity of cancer-promoting proteins called kinases. The experimental drug trametinib (GSK1120212) works by blocking a kinase called MEK. In this study, the researchers will give volunteers trametinib for a short period of time so that they can evaluate how MEK and the other kinases act before and after trametinib is given. This study is not intended to treat cancer; it is looking at ways that the investigators may treat cancer in the future. To be eligible, participants must have stage I-III triple negative (ER-/PR-/HER2-) breast cancer, have not yet had surgery, and not be planning to receive any treatment before surgery.

Targeted Therapy with Chemotherapy Before Surgery in Stage II-III Breast Cancer

Next Generation Sequencing to Evaluate Breast Cancer Subtypes and Genomic Predictors of Response to Therapy in the Preoperative Setting for Stage II-III Breast Cancer (NCT01959490)

Summary

Researchers are trying to determine ways to predict which types of tumors will respond best to which drug combinations. Giving chemotherapy and targeted therapy before surgery--called neoadjuvant treatment--allows researchers to study the effect a drug combination has on the cancer cells. Trastuzumab (Herceptin®) is a targeted therapy used to treat HER2+ breast cancer. Bevacizumab (Avastin®) is a drug that keeps tumors from developing the blood vessels they need to survive. In this trial, patients with stage II-III HER2+ tumors will receive Herceptin and chemotherapy before surgery and patients with stage II-III HER2- tumors will receive Avastin and chemotherapy before surgery.
This is a Phase II trial

Vaccines and Immunotherapy

A Breast Cancer Vaccine for Metastatic or Triple-Negative Breast Cancer

Clinical Trial of Autologous cMet Redirected T Cells Administered Intratumorally in Patients With Breast Cancer (NCT01837602)

Summary

Researchers are investigating whether they can use vaccines to teach the immune system to go after cancer cells. This study will test a vaccine developed for each patient by adding special genetic material to T-cells that are removed from and then infused back into the body. The genetic material teaches the T-cells to fight cancer cells. To be eligible, participants must have either metastatic breast cancer that has stopped responding to at least one standard therapy or newly diagnosed operable triple negative breast cancer.
This is a Phase I trial

Other treatment

Chemotherapy With Microwave Thermotherapy Before Surgery

Randomized Pivotal Trial to Assess the Safety and Efficacy of Preoperative Focused Microwave Thermotherapy Plus Preoperative Chemotherapy Versus Preoperative Chemotherapy Alone for Cytoreduction of Large Breast Cancer in... (NCT01204801)

Summary

Large tumors are sometimes treated with chemotherapy prior to surgery (neoadjuvant treatment) in order to reduce the tumor's size. If the tumor does shrink, the surgeon may be able to perform a lumpectomy instead of a mastectomy. Studies have shown that cancer cells are sensitive to microwave-generated heat, and that using microwave-generated heat therapy prior to surgery can help shrink tumor size. The purpose of this study is to determine whether neoadjuvant treatment that combines focused microwave heat treatment and chemotherapy is more effective than neoadjuvant chemotherapy alone for shrinking large breast tumors.
This is a Phase III trial

Low-Dose Chemotherapy with Aspirin After Neoadjuvant Therapy

Low Dose Metronomic Cyclophosphamide and Methotrexate Chemotherapy in Combination With Aspirin in Patients With Stage II-III Breast Cancer Who Fail to Achieve a Pathologic Complete Response After Neoadjuvant Chemotherapy (NCT01612247)

Summary

There is growing evidence that aspirin may have anti-cancer properties. This may be because aspirin reduces inflammation by blocking the activity of the cylcooxygenase-2 (COX-2) protein, which has been shown to play a role in cancer metastases. Neoadjuvant chemotherapy is given before surgery to shrink tumor size. In this study, patients with stage II-III breast cancer whose tumors can still be seen at the time of surgery after neoadjuvant chemotherapy will be treated with oral low dose continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and radiation to study the safety and effectiveness of this drug combination.

Metformin & Atorvastatin Before Surgery to Study Their Effect on Cancer Cells

Pre-Surgical "Window of Opportunity" Trial of the Combination of Metformin and Atorvastatin in Newly Diagnosed Operable Breast Cancer (NCT01980823)

Summary

Studies suggest that drugs used to treat diabetes and high cholesterol may be effective breast cancer treatments. Metformin is a medication used to treat patients with diabetes. Atorvastatin is used to treat high cholesterol. By giving these drugs before surgery--called neoadjuvant treatment--researchers can study the effect that they have on breast cancer cell. This study will investigate the effect that Metformin and Atorvastin have on breast cancer cells in women who will be having surgery to treat DCIS or breast cancer.
This is a Phase O trial

Preventing Breast Cancer

Exercise During Treatment for DCIS and Early-Stage Disease

Prescriptive Exercise Intervention During Active Treatment for Early Stage Breast Cancer Patients: A Breast Cancer Rehabilitation & Exercise Laboratory (NCT01157130)

Summary

Studies suggest that exercise may reduce the risk of a breast cancer recurrence as well as improve quality of life. Precisely how exercise reduces recurrence risk is not fully understood. However, scientists think that exercise during breast cancer treatment may affect proteins and hormones, such as insulin and estrogen, that are related to cancer growth. The goal of this trial is to determine the effect that exercise instruction has on exercise levels, biological measures, and psychosocial factors. To be eligible, participants must have been recently diagnosed with DCIS or early-stage breast cancer and not yet begun treatment. In addition, participants must be planning to receive treatment that includes chemotherapy and/or radiation.

Diagnosing Breast Cancer

Evaluating a New Tool to Identify Sentinel Node During Sentinel Lymph Node Biopsy

A Pivotal, Prospective, Open-Label, Multicenter Paired Comparison Study Of SentiMag/SiennaXP And The Standard Of Care In Patients With Breast Cancer Who Are Undergoing Lymph Node Mapping As Part Of A Sentinel Node Biopsy Procedure (NCT02336737)

Summary

The sentinel node is the lymph node under the arm that breast cancer cells are most likely to spread to first. Currently, surgeons use a radioisotope and blue dye during the sentinel lymph node biopsy (SLNB) procedure to locate the lymph nodes. SentiMag®/SiennaXP® is a new method for finding the lymph nodes that uses a magnetic tracer, SiennaXP, and the Sentimag magnetic probe instead, and avoids the use of radioisotopes. This study is designed to determine if the SentiMag/SiennaXP system is as good as the current standard of care for finding the sentinel lymph node. To be eligible for this study, a patient must be scheduled for sentinel node biopsy at one of the trial sites.

Using 3D Mammography to Evaluate Breast Tumors

Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions. (NCT01773850)

Summary

Tomosynthesis is an FDA-approved imaging technique that can create a 3-D image of the breast. It does not require as much breast compression during imaging, making it less painful than conventional mammography. Studies suggest it may also be more accurate than conventional mammography. The goal of this study is to see if radiologists can confidently and accurately identify breast tumors identified through conventional mammography with breast tomosynthesis. To be eligible, participants must have received a breast cancer diagnosis following a conventional mammogram and be scheduled to have a clinical surgical breast biopsy.

LED Image-Guided Sentinel Lymph Node Biopsy for Clinically Node-Negative Breast Cancer

Evaluation of Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma (NCT02316795)

Summary

The sentinel lymph node (SLN) is the lymph node that the tumor's cancer cells are most likely to spread to first. Using fluorescent light to differentiate cancer cells, which have a high fluorescence, from normal cells, which have a lower fluorescence, may improve the SLN biopsy procedure. LED is one type of fluorescent light. This study will look at the effectiveness of an LED-image guided SLN biopsy in patients with clinically node-negative breast cancer (or melanoma) who are scheduled to have a SLN biopsy.
This is a Phase O trial

Axillary Ultrasound to Detect Cancer in the Lymph Nodes

A Prospective Randomized Trial of Sentinel Lymph Node Biopsy Versus no Additional Staging in Patients With Clinical T-1-T2 N0 M0 Invasive Breast Cancer and Negative Axillary Ultrasound (NCT01821768)

Summary

During a lumpectomy, the standard of care is for the surgeon to perform a sentinel lymph node biopsy (SLNB). This procedure involves identifying, removing, and examining the sentinel node--the first lymph node under the arm to which the cancer cells are most likely to have spread. Ultrasound uses high-frequency sound waves to produce images. Studies suggest that axillary ultrasound (AUS)—images of the underarm area—may be as good as SLNB for determining whether the cancer has spread to the lymph nodes. In this study, half of the women will receive AUS. The other half will receive AUS and SLNB. This will allow the researchers to determine if AUS is as effective as SLNB. To be eligible for this trial, the patient must have a tumor less that 5 cm., no palpable nodes, and no evidence of metastatic disease. (A palpable node is one that doctors can feel with their fingertips.)

MRI and Optical Imaging for Improved Diagnosis

Combined MRI and Optical Imaging to Improved Breast Cancer Diagnosis (NCT00610467)

Summary

Magnetic resonance imaging (MRI) is used to gather information about an area in the breast that is suspicious or already confirmed to be cancerous. Optical imaging is a noninvasive technique for studying breast tissue that may be helpful in distinguishing between malignant and benign lesions. The purpose of this study is to investigate whether adding optical imaging to MRI using combined Magnetic Resonance Imaging and Diffuse Optical Tomography (MRI/DOT) is more accurate than MRI alone at diagnosing breast cancer.

A Study of a New Type of Dye for Use During a Sentinel Lymph Node Biopsy

A Phase I/II Study of VST-1001 (Dilute Fluorescein) for Lymphatic Mapping and Localization of Lymph Nodes Draining a Primary Tumor Site in Patients With Clinically Node Negative Breast Cancer (NCT02294565)

Summary

Breast cancer surgery typically includes a sentinel lymph node (SLN) biopsy. The SLN is the first lymph node the cancer cells will spread to. A biopsy of the SLN allows the surgeon to see if the tumor may have spread. A special dye is used during breast cancer surgery to identify the sentinel node. VST-1001 is a new type of dye that can be used during a SLN biopsy. This study will determine the best dose of VST-1001 needed for a surgeon to identify the sentinel node. It will also determine how effective VST-1001 is when combined with the radiotracer used to determine which additional nodes should be removed. To be eligible, a woman must be clinically node-negative—have no enlarged nodes detected by her doctor.
This is a Phase I-II trial

Support/Education

Providing Lymphedema Education to Breast Cancer Patients Prior to Surgery

Effect of Intensive Education on Breast Cancer Patient's Understanding of Lymphedema (NCT02073045)

Summary

Women and men who have breast cancer surgery are at risk of developing lymphedema—a painful swelling of the arm and hand. Educating patients about risk factors for and symptoms of lymphedema may improve their ability to identify, and reduce, these symptoms after surgery. This study is looking at the impact a lymphedema education program provided before surgery has on breast cancer patients. To be eligible, a patient must be scheduled for surgery at University Hospitals Seidman Cancer Center in Cleveland, Ohio.

Comparing Therapies for Depression Related to Breast Cancer

Interpersonal Therapy for Depression in Breast Cancer (NCT01191580)

Summary

Depression can negatively affect a cancer patient's adherence to treatment, survival, symptom management, psychosocial functioning, and quality of life. The goal of this trial is to compare the effectiveness of three different types of therapy (Interpersonal Psychotherapy, Problem-Solving Therapy, and Brief Supportive Psychotherapy) in improving depressive symptoms, psychosocial functioning, and quality of life among patients with breast cancer who have been diagnosed with Major Depressive Disorder.
This is a Phase IV trial

Counseling for Breast Cancer Patients Age 70 and Over

Pilot of a Geriatric Group Psychoeducational Intervention for Elderly Patients With Cancer (NCT00984321)

Summary

Many women seek counseling after a breast cancer diagnosis. This counseling program was developed to meet the specific needs of older cancer patients, who often find themselves facing problems related to both cancer and aging. The goal of this trial is to see whether a counseling program can help reduce depression, anxiety, and feelings of loneliness and isolation as well as improve the quality of life of older women with breast cancer. To be eligible, participants must be receiving treatment at Memorial Sloan-Kettering Cancer Center.

Genetic Testing Decisions In Newly Diagnosed Ashkenazi Women

Understanding Decision Making Processes for Undergoing Genetic Testing Among Women With Newly Diagnosed Breast Cancer (NCT01386411)

Summary

Women who are diagnosed with breast cancer at a young age and/or who are of Ashkenazi Jewish descent are more likely to carry the BRCA1 or BRCA2 genetic mutation that increases risk for breast and ovarian cancer. Genetic testing for the BRCA1/2 mutation can help women make decisions about their breast cancer treatment. The purpose of this trial is to see whether women prefer having genetic testing before or after their breast cancer surgery. The study will also look at how women feel about their decision at a later date. To be eligible for this trial, participants must be 18 – 50 years old at diagnosis, be of Ashkenazi Jewish descent, and be planning to undergo breast surgery as part of their treatment.

Health Education for Reducing Chemotherapy-Related Weight Gain

Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy (NCT01941784)

Summary

Weight gain is a common side effect of chemotherapy treatment. The average patient gains about 5-8 pounds over a year. THRIVE (Taking Health Realization Into Valued Eating and Exercise) is a health education program that may help reduce weight gain and improve the quality of life of women undergoing chemotherapy. The goal of this study is to determine the effectiveness of the THRIVE project for preventing weight gain associated with chemotherapy treatments in women with newly diagnosed stage I-IV breast cancer who have recently started or are schedule to receive chemotherapy.

Lifestyle Changes During Radiation Therapy to Improve Outcomes

The Role of Lifestyle Factors in Breast Cancer-Related Outcomes (NCT02079662)

Summary

Researchers are studying the effects that lifestyle has on the risk of a breast cancer recurrence, quality of life, physical functioning, hormone levels and immune function. This study is looking at the effect that a comprehensive lifestyle change program that addresses diet, exercise, and stress has on women with stage III breast cancer who are scheduled to have a 4 to 6-week course of radiation. To be eligible patients must have a body mass index (BMI) of 25 or higher. They must also not eat more than 3 servings of fruits/vegetables a day or exercise more than 75 minutes per week.

Helping Patients Learn to Cope with Symptoms and Side Effects of Cancer and its Treatments

Patient Outcomes of a Self-care Management Approach to Cancer Symptoms: A Clinical Trial (NCT02288169)

Summary

Cancer and its treatments can result in symptoms and side effects that lead to depression, anxiety and a diminished quality of life. Helping patients learn how to manage difficult symptoms on their own may diminish suffering, improve quality of life and decrease emergency room visits and associated costs. COPE (Creativity, Optimism, Planning, Expert guidance) is a program initially developed by researchers at the University of South Florida to help cancer caregivers. This study is looking at whether the COPE program works well for cancer patients too. This study is enrolling patients with breast, colorectal, lung or prostate cancer patients who are experiencing distress.

Providing Support to Newly Diagnosed Patients

A Randomized Controlled Trial of the Impact of ICCAN on Cancer Treatment Completion and Quality of Life (NCT01742143)

Summary

Breast cancer treatment is most effective when a patient is able to follow her treatment plan. The Integrated Cancer Care Access Network (ICCAN) program provides individualized assistance to women being treated at New York City hospitals who are low-income or have other problems that may make it difficult for them to stay on their treatment. Women who take part in the program meet monthly with a facilitator to get assistance and support. This study is comparing the ICCAN program to the standard services provided in New York City hospitals, which include meeting with a social worker or a patient navigator. To take part, patients must speak English, Spanish, or Mandarin, have been diagnosed with breast cancer within the past month, and be currently receiving or scheduled to start chemotherapy or radiation.

Brief Behavioral Therapy to Improve Chemotherapy-Related Sleep Problems

Feasibility, Acceptability and Mechanisms of Brief Behavioral Therapy (BBT) for Sleep Problems During Chemotherapy: A Phase II Randomized Controlled Trial (NCT02002533)

Summary

Sleep problems are a common side effect of chemotherapy. Sleep disorder counseling may reduce fatigue and insomnia and improve quality of life in cancer patients. Brief Behavioral Therapy (BBT) is a technique that consists of insomnia education, stimulus control, discouragement of napping and encouragement of exercise and sleep. Researchers are interested in seeing if BBT is an effective way to improve chemo-related sleep problems. This study is investigating whether BBT is more effective than the Healthy Eating Education (HEAL) program in improving sleep problems in patients with stage I-III breast cancer undergoing chemotherapy. To be eligible, participants must have sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy.
This is a Phase II trial

Using Patient Navigators to Address Racial Disparities in Cancer

Accountability for Cancer Care Through Undoing Racism and Equity (NCT01954641)

Summary

Statistics show that although a larger percentage of white Americans are diagnosed with breast and lung cancer, a larger proportion of African-Americans die from these diseases. Researchers are trying to find ways to reduce this disparity. Studies suggest that patient navigators who have comprehensive training in cancer issues, health literacy and communication techniques can benefit patients. The Accountability for Cancer Care through Undoing Racism and Equity (ACCURE) trial is comparing patients who work with patient navigators and patients who receive usual support and care. This study is enrolling white and African-American women and men who are being treated for stage I or II breast (or lung) cancer.

An Educational Tool for Women Considering Breast Reconstruction

Decisional Aid Intervention for Women Considering Breast Reconstruction (NCT01951534)

Summary

Many women find that it is not easy to decide whether to have breast reconstruction. Researchers have developed a web-based Breast Reconstruction Decisional Aid (BRDA) they hope will help women make this decision. This study is comparing the BRDA to an educational pamphlet and routine care. The researchers will see if women find the BRDA useful and how it influences their decision-making. The researchers will also look at what effect the BRDA has on women's breast reconstruction knowledge, attitudes about breast reconstruction, decisional conflict, preparedness and completeness of preparation, anxiety, and discussion with their oncologist.

A Study Comparing Online and In-Person Pain Management Programs for Cancer Patients

An Accessible Mobile Health Behavioral Intervention For Cancer Pain (NCT02266017)

Summary

Many cancer patients experience pain from the cancer or its treatments. Studies have found that these patients can benefit from programs that increase their confidence in their ability to manage their pain. It is difficult for patients who do not live near a medical center to participate in a pain management program. Mobile health (mHealth) technologies that use a tablet computer or videoconferencing may be beneficial for these patients. This study is comparing the effectiveness of an mHealth program and a traditional in-person pain management program in patients who were diagnosed with breast cancer within the last year. This study also is enrolling patients with lung, prostate or colorectal cancer.

Exercise and Counseling to Prevent Lymphedema

Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection (NCT00376597)

Summary

A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection. This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection.

Self-Care Toolkit for Managing Side Effects After Surgery

Evaluation of a Self-Care Toolkit in Surgical Breast Cancer Patients (NCT02387320)

Summary

Side-effects associated with breast cancer surgery can include pain, anxiety, nausea, fatigue, and sleep disturbance. Researchers have developed a self-care toolkit to help women learn about mind-body skills and tools that can help them cope with these side effects. This study will compare the effectiveness of this kit to the standard of care for helping women reduce these side effects. To be eligible, a woman must be newly diagnosed with breast cancer and be receiving treatment at the San Antonio Military Medical Center Oncology Clinic.

Comparing Two Strategies for Quitting Smoking After a Cancer Diagnosis

Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial (NCT01871506)

Summary

Between 10 and 30 percent of people diagnosed with cancer are current smokers. Studies have found that people who continue smoking after a cancer diagnosis have shorter survival times, are more likely to have treatment-related complications, and are at increased risk of developing a second cancer. Currently, only about half of all cancer patients report having been asked about their tobacco use. This study is comparing two strategies to promote smoking cessation in people who are newly diagnosed with, or likely to have, cancer. To be eligible, participants must have smoked a cigarette, even a puff, in the past week and be willing to consider trying to quit smoking using counseling and/or smoking cessation medication. This study is enrolling women and men diagnosed or suspected of having breast or other types of cancers, receiving care at Massachusetts General Hospital Cancer Center or Memorial Sloan Kettering Cancer Center.
This is a Phase IV trial

A Program to Reduce Insomnia (Trouble Sleeping) Caused by Cancer or its Treatment

Brief Behavioral Intervention for Insomnia During Chemotherapy (NCT02165839)

Summary

Many women report that they experience insomnia--trouble sleeping--during their breast cancer treatment. A behavioral therapy program may help breast cancer patients cope with their insomnia. This study will compare a behavioral therapy program for insomnia to a healthy eating program in women being treated with chemotherapy or a biological therapy, like Herceptin, for early-stage breast cancer. To be eligible, a woman must have insomnia that began or got worse when she was diagnosed with cancer or began systemic treatment with chemotherapy or biological therapy.
This is a Phase III trial

Education

Chemotherapy Education for African-American Women

The ACTS Intervention to Reduce Breast Cancer Treatment Disparity (NCT01184066)

Summary

The 5-year survival rate after a first breast cancer diagnosis is 13% lower in African-American women than in white women. This disparity cannot be explained by stage of disease at time of diagnosis. However, it might be be due to treatment non-adherence and/or treatment delays following the initial diagnosis. If so, this disparity could be decreased through clinical interventions that increase adherence to chemotherapy. The ACTS (Attitudes, Communication, Treatment, Support) Intervention is a single educational session delivered by an African-American breast cancer survivor. It uses video, graphics, teaching tools, and supportive testimony to encourage chemotherapy adherence. The goal of this trial is to determine whether the ACTS intervention can increase treatment adherence among African-American women who will be receiving chemotherapy.

Surveys/Interviews

Quality of Life After Breast Reconstruction

Mastectomy Reconstruction Outcomes Consortium (MROC) Study (NCT01723423)

Summary

For many women, breast cancer surgery includes a mastectomy followed by breast reconstruction. The Mastectomy Reconstruction Outcomes Consortium (MROC) has developed a web-based survey to help researchers learn more about how satisfied women are with their reconstructive surgery, what complications they experience, and how the surgery affects their psychological and emotional well-being and physical functioning. This study will evaluate the experiences of women who are having one of eight commonly used breast reconstruction surgeries at one of the 13 cancer centers that are part of the MROC.This study also is enrolling women without a history of breast cancer who are having a mastectomy to prevent breast cancer from occurring.

BRCA Gene Mutations in Latinas with Breast Cancer

BRCA1 and BRCA2 Mutations and Triple Negative Disease in Hispanic/Latino Breast Cancer Subjects (NCT01251900)

Summary

Some women who have triple negative (ER, PR, and HER2-negative) breast cancer also have a BRCA1 or BRCA2 genetic mutation. The number of Latinas with triple negative breast cancer who also have a BRCA1/2 mutation is not known. Learning more about BRCA1/2 mutation rates among Latinas will help researchers provide better treatment to this group of women. The purpose of this trial is to study DNA samples taken from saliva and the medical histories of Latinas who have been diagnosed with breast cancer. Participants can reside anywhere in the U.S.

  • Participation TimeSaliva sample and questionnaire by mail
  • No Visits Required for this TrialNo travel required 

Helping Parents Talk to Their School-Age Children About Cancer

Enhancing Connections Telephone Program: A Cancer Education Program for Parents (NCT02129049)

Summary

A cancer diagnosis can cause emotional distress in both parents and children. But it can be difficult for parents to talk to their children about their cancer or support their children while undergoing cancer treatment. Studies have found that the Enhancing Connections Program, an in-person educational program, can decrease parents' depression and anxiety; improve parenting quality, parenting skills and confidence; and enhance the child's behavioral-emotional adjustment. Providing this education program by telephone may help parents talk with their school-age children about their cancer. This trial is investigating the effectiveness of using the Enhancing Connections Program by telephone to improve communication between patients with early stage cancer and their children. To be eligible, participants must have had a diagnosis of stage 0-III breast cancer within the last seven months.

Surgical Choices Made by Women with DCIS or Stage, I, II or III Breast Cancer

Treatment Decisions and Breast Cancer: Psychosocial Outcomes (NCT02263014)

Summary

Contralateral prophylactic mastectomy (CPM) is a surgical procedure in which the healthy breast is removed along with the cancerous one. Researchers are interested in learning more about why some women choose CPM and others do not and how the surgical decisions women make affect their quality of life as breast cancer survivors. Results from this study will be used to help doctors provide the best information to breast cancer patients who are making treatment decisions. To be eligible, a woman must be newly diagnosed with breast cancer, married or living with a partner for a year or more, and be receiving breast cancer treatment at the MD Anderson Cancer Center or the Kelsey-Seybold Clinic in Houston.

The Health of Women Study: Learning About the Causes of and Ways to Prevent Breast Cancer

The Health of Women (HOW) Study (NCT02334085)

Summary

The Health of Women (HOW) study is an international online study for women and men with or without a history of breast cancer. Participants in this study complete questionnaires about their health, job, diet and family history, among other topics. The researchers will use the information collected from these questionnaires to gain insight into what causes breast cancer and how to prevent it. This study is open to all women and men of every age, ethnicity, sexual orientation and occupation.

Breast Cancer in Young Women

Identification of Novel Genetic Risk Factors That Contribute to the Risk for Breast Cancer (NCT00276120)

Summary

Breast cancer is the leading cause of cancer deaths in women 20-39 years of age. The goal of this trial is to identify the genetic factors that distinguish breast cancer in younger women compared to older women. The researchers hope that identifying these genetic factors will lead to new treatments for younger women who have been diagnosed with breast cancer or who are at high-risk for developing the disease. All women who were diagnosed with breast cancer at age 40 or younger (regardless of current age) are eligible to participate. Because all study-related materials will be mailed, participants can live anywhere in the U.S.

  • Participation TimeBlood sample and questionnaire by mail
  • No Visits Required for this TrialNo travel required 

A Study of the Inherited KRAS-Variant Mutation and Breast Cancer Risk

Clinical Validation of the Role of microRNA Binding Site Mutations in Cancer Risk, Prevention and Treatment (NCT02253251)

Summary

Researchers have identified an inherited genetic mutation—a KRAS-variant—that may increase a person's risk of developing breast or other types of cancer. This study will follow participants for 10 years in order to analyze the association between the KRAS-variant mutation and cancer risk. The researchers will also look at the effect that different lifestyle factors have on cancer risk. All participants will have a saliva sample tested for the KRAS-variant. To be eligible, participants must have a personal or family history of breast cancer.

Cancer Support Community Online Survey: The Cancer Experience Registry

Cancer Experience Registry: An Online Initiative to Change the Future of Cancer Care (NCT01295658)

Summary

Researchers are trying to develop programs that can successfully address the needs of people who have experienced breast cancer. The Cancer Experience Registry is an online survey designed to identify and understand the emotional and social needs of women and men who have had a breast cancer diagnosis. It is open to anybody who has been recently diagnosed or is undergoing treatment, living with metastatic disease or years past treatment. This project is sponsored by The Cancer Support Community, an international non-profit dedicated to providing support, education and hope to people affected by cancer.

  • Participation TimeOnline questionnaire
  • No Visits Required for this TrialNo travel required 

Quality of Life After a Breast Cancer Diagnosis

A Prospective Study on Newly Diagnosed Breast Cancer Patients: A 5 Year Follow Up on Quality of Life (NCT01176838)

Summary

More research is now being conducted on quality of life after a breast cancer diagnosis. Most of the information we now have about quality of life comes from studies that have followed women for two years. The goal of this study is to learn more about quality of life by following participants for five years, and by asking them questions about many areas of their life, including their daily activity and social interactions, levels of anxiety and depression, and their personal and sexual relationships. To be eligible, participants must be planning to receive treatment for early-stage breast cancer at the Wake Forest University Comprehensive Cancer Center.

Assessing How Patients Experience Cancer Care

Assessing the Patient Experience in Cancer Care: An Observational Communication Study (NCT01621295)

Summary

Communication between cancer patients and their doctors is an important component of cancer care, as it contributes to patient satisfaction, medication adherence, and quality of life. To best meet patients' needs, it is important to study and understand the decision-making process that takes place in routine cancer consultations between cancer patients and their doctors. In this study, researchers will observe the conversations and experiences patients have in clinical interactions with their doctors. The researchers will use what they learn to identify communication practices that provide the greatest benefit for cancer patients and the cancer care team.

Targeted Intraoperative Radiotherapy (TARGIT) Registry Trial

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery (NCT01570998)

Summary

Radiation is used to kill any breast cancer cells that may not have been removed during surgery. Targeted intraoperative radiotherapy is delivered during surgery immediately after the tumor has been removed. This allows the radiation to accurately target the tissue surrounding the tumor, where the risk of recurrence is highest. It takes about 20-35 minutes to provide intraoperative radiotherapy. This study, the Targeted Intraoperative Radiotherapy Trial (TARGIT), will follow women who receive this type of radiation therapy for five years, allowing researchers to study its effectiveness and side effects. This registry trial is open to patients who are receiving a lumpectomy (breast conserving surgery) and who are considered to be at low risk of having a local recurrence. If indicated, participants will also receive whole breast radiation.
This is a Phase IV trial

Individualized Radiotherapy Education for Patients with Stage I-III Breast Cancer

Impact of Individualized Radiotherapy Plan Review in Patients Receiving Adjuvant Radiotherapy for Breast Cancer (NCT02366806)

Summary

The standard of care for treating early-stage breast cancer is a lumpectomy followed by radiation. Prior to starting radiation, patients typically receive general information about radiation therapy and its potential side effects. An in-depth, personalized treatment education plan may be more beneficial. This study will compare the benefits of a standard radiation education plan to a personalized radiation education plan in patients with early-stage breast cancer. To be eligible, a patient must be scheduled to receive radiation therapy for early-stage breast cancer at the University of California, Davis.

Lymphedema Prevention and Detection

To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-Risk Status (NCT00383500)

Summary

The purpose of this research study is to detect patients who might be at increased risk for the development of arm lymphedema based upon repeated non-invasive examination of the arms. When preventive interventions are appropriate, this study will compare the effectiveness of the usual treatments of massage and elastic sleeves with a new device, Flexitouch, which electronically simulates the effect of massage upon lymph flow.

Arm Strength & Range of Motion Before and After Breast Cancer Surgery

Breast Clinic Strength and Range of Motion Study (NCT00489125)

Summary

Breast cancer surgery can affect a woman's arm strength and her shoulder range of motion. It can also cause lymphedema, a painful swelling of the arm or hand. In this study, researchers will evaluate a woman's strength and range of motion before she has surgery and compare it to the strength and range of motion she has after surgery. This information will help the researchers learn more about how breast cancer surgery affects a woman's arm and shoulder. It will also help them identify better ways to provide care after surgery. To be eligible, participants must be planning to have their breast cancer surgery at the Comprehensive Cancer Center Breast Clinic at Wake Forest University Baptist Medical Center.

Side Effects of Ovarian Removal in Women with a BRCA Mutation

Side Effects of Ovarian Removal in Women with a BRCA Mutation (NCT01948609)

Summary

Women who carry a BRCA1 or BRCA2 genetic mutation have a greatly increased risk of developing breast and ovarian cancer. Surgically removing the fallopian tubes and ovaries (called a risk reducing salipingo-ooporectomy or RRSO) reduces the risk of both breast and ovarian cancer because it reduces estrogen production. However, shutting down estrogen production can increase the risk of heart disease, memory problems, osteoporosis and bone fractures and result in a decline in wellbeing and sexual function. This study is comparing the health of women with a BRCA mutation who choose RRSO with women with a BRCA mutation who do not choose RRSO. To be eligible for this study, a woman must have had a genetic test that showed she has a BRCA1 or BRCA2 genetic mutation.

Sexual and Reproductive Health Study

Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma (NCT01788839)

Summary

Cancer and its treatment may affect sexual and reproductive health. To help researchers learn more about the problems women face, participants in this study will complete questionnaires on sexuality and pregnancy before, during, and after cancer treatment. The information will be used to help doctors identify which women are most likely to have early menopause or develop sexual problems during cancer therapy, or have difficulty getting pregnant after cancer treatment. To be eligible for this study a woman must be age 50 or younger, newly diagnosed with breast cancer, and planning on having, or within one month of starting, chemotherapy.

The Young Women's Breast Cancer Study

Helping Ourselves, Helping Others: The Young Women's Breast Cancer Study (NCT01468246)

Summary

Young women with breast cancer have unique needs and concerns. The goal of this study is to follow a large group of young women with breast cancer over time to learn more about the types of tumors they develop, the treatments they have, the side effects they experience, and the psychosocial concerns they face. The researchers are also interested in seeing if there is a relationship between tumor biology and patient outcome. To be eligible, participants must have been diagnosed with breast cancer at age 40 or younger.

Screening

A Blood Test for Breast Cancer Detection

Free Fatty Acid Metabolite Biomarkers for Cancer (NCT01692951)

Summary

Scientists are trying to develop a blood test for breast cancer detection. Free fatty acid metabolites are small molecules produced by tumors. Researchers have developed a blood test that can identify six cancer-related metabolites. This study is looking at whether the test can accurately detect breast cancer. To be eligible, a woman must be having a breast biopsy or breast cancer surgery. (The blood test may also identify lung and colon tumors and patients with these types of cancers are also being enrolled in this study.)

Activities

Increasing Physical Activity During Chemotherapy for Early Stage Breast Cancer

A Randomized, Controlled Trial to Determine the Effects of an Exercise Intervention on Physical Activity During Chemotherapy for Patients With Early Stage Breast Cancer (NCT02159157)

Summary

Researchers have found that breast cancer survivors who are physically active are at lower risk of having a breast cancer recurrence. Recent studies suggest that taking part in physical activities during cancer treatment may also be beneficial. There are different ways to encourage breast cancer patients to become more active during their treatment. This study is comparing two approaches to increasing physical activity in breast cancer patients who are scheduled to begin chemotherapy. To be eligible, participants must be scheduled to begin treatment within 4 weeks.

Exercise or Mind-Body Program Before Surgery

The Preoperative Health & Body Study (NCT01516190)

Summary

This study is designed to look at the changes that occur in women who take part in exercise and mind-body programs between their breast cancer diagnosis and breast surgery. The investigators are interested in seeing if these programs can decrease stress and anxiety and improve mood and quality of life during this time. The investigators are also interested in looking at whether this type of short program affects certain markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development. To be eligible, participants must not be planning to receive chemotherapy or hormone therapy before surgery.

Managing Side Effects

Early Identification and Treatment of Lymphedema

The Use of Bioimpedance to Determine Pre-Clinical Lymphedema in the Post-Operative Breast Cancer Patient (NCT01521000)

Summary

Lymphedema is a painful swelling of the arm that can develop as a result of breast cancer treatment. The goal of this study is to determine whether identifying lymphedema and treating it as early as possible can help keep it from progressing. The study is also investigating whether bioimpedance, a technique that uses electric current to measure tissue volume, is better than the methods that are currently available for measuring lymphedema.To be eligible, participants must have undergone a sentinel lymph node biopsy or axillary node dissection.

Comparing Quality of Life After Chemo in Women Over & Under 65

Adjuvant Therapy in Older Versus Younger Women With Breast Cancer: Longitudinal Impact of Adjuvant Chemotherapy on Functional Status, Comorbidity and Quality of Life (NCT01030250)

Summary

Almost half of all new breast cancers diagnosed in the US are in women 65 years of age or older. Aging is associated with changes in physiology that can impact the toxicity and side effects associated with chemotherapy. More information is needed to determine whether treatment or dose recommendations should change as women grow older. More information is also needed about risk factors for toxicity other than age, such as the presence of other illnesses, nutritional status, cognitive functioning, and access to social support. The goal of this study is to learn more about and compare the toxicities and side effects experienced by women over and under age 65. Participants of any age are eligible for this study.

Yoga for Breast Cancer Patients Undergoing Chemotherapy

A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms (NCT02360904)

Summary

Yoga is a mind-body intervention that has been shown to reduce fatigue and improve overall quality of life in breast cancer patients receiving chemotherapy. This study is comparing the effect that yoga has on quality of life when the classes are started immediately or three months after beginning chemotherapy. To be eligible, patients must be scheduled to receive chemotherapy or have been on chemotherapy for less than two weeks; not planning on starting yoga; and not have done yoga regularly within 3 months of enrolling in the study.

Acupuncture For Treating Post-mastectomy Pain, Nausea and Anxiety

A Pilot Randomized Controlled Trial to Assess the Impact of Acupuncture on Post-mastectomy Pain, Nausea, Anxiety and Ability to Cope. (NCT02122796)

Summary

Some of the most common side effects that occur after a mastectomy are pain, nausea, and anxiety. Acupuncture involves inserting thin, sterile needles at certain points in the body. Studies have found that acupuncture can help relieve fatigue, hot flashes, nausea, vomiting, and pain. This study is looking at whether acupuncture is better than the standard of care for reducing pain, nausea and anxiety after a mastectomy. To be eligible, patients must be scheduled to have a mastectomy to treat stage I-III breast cancer.

Yoga During Radiation Therapy

Biobehavioral Effects of Yoga for Women With Breast Cancer Undergoing Radiotherapy (NCT01202851)

Summary

Researchers believe that mind-body interventions can be beneficial to women undergoing breast cancer treatment. Yoga is a mind-body intervention that has been shown to reduce fatigue as well as improve quality of sleep, physical vitality, and overall quality of life in women being treated for breast cancer. This study will compare the effectiveness of a yoga program with a stretching/relaxation program for improving the physical and emotional well-being of women with DCIS or Stage I-III breast cancer who are undergoing radiation treatment after surgery. The study will also include a group of women who will not take part in either the yoga or stretching/relaxation program. To be eligible, participants must be planning to receive radiation therapy following breast surgery. In addition, participants must not have practiced yoga in the year prior to breast cancer diagnosis.
This is a Phase III trial

Exercise in Stage I-III Breast Cancer Patients (Age 65 and up) Receiving Radiation

Phase 2 Randomized Study of a Walking Intervention for Radiation-related Fatigue Among Breast Cancer Patients Receiving Adjuvant Radiation (NCT02434367)

Summary

Studies suggest that patients who exercise have less fatigue during radiation therapy. Walk with Ease (WWE) is a community-based walking program designed by the Arthritis Foundation. In this study, researchers will compare fatigue levels between breast cancer patients who take part in the WWE program and those who do not. The researchers will also analyze patients' blood samples in order to study the relationship between inflammatory biomarkers, exercise, and fatigue. To be eligible, patients must be 65 or older, scheduled to receive hypofractionated or standard fractionated radiation therapy to the breast or chest wall following surgery, and not currently be walking ≥120 minutes per week.
This is a Phase II trial

Massage to Reduce Anxiety Before Breast Cancer Surgery

Utility of Preoperative Massage in Breast Surgery Patients (NCT01667328)

Summary

It is not uncommon for patients to report feeling anxious prior to their breast cancer surgery. Studies have demonstrated that massage can offer some health benefits for people with cancer. Massage has also been found to be help reduce anxiety. This study is investigating whether breast cancer patients who receive massage therapy by a licensed massage therapist before surgery have lower anxiety levels than those who do not receive massage therapy.

Impact of Lymphedema on Quality of Life After Breast Cancer

Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer. (NCT01521741)

Summary

Breast cancer treatments can result in long-term, painful swelling of the arm and hand, a condition called lymphedema. The goal of this study is to determine how the symptoms and functional disability that accompany lymphedema can impact breast cancer survivors' quality of life. To be eligible, participants must be planning to have surgery and receive follow-up care for breast cancer at Massachusetts General Hospital.

Topical Menthol Cream for Chemotherapy-Induced Neuropathy

Topical Menthol for CIPN: a Randomized, Placebo Controlled Phase II Trial (NCT01855607)

Summary

Peripheral neuropathy—nerve damage that causes pain or discomfort in the hands and feet—is a potential side effect of the taxane drugs used in many chemotherapy regimens. Menthol is often used in pain relieving balms, massage oils and liniments because it is cooling and anaesthetic when applied to the skin. This study is investigating whether a topical cream that contains menthol is more effective than a topical cream that does not contain menthol in reducing neuropathy-related pain in breast cancer patients. To be eligible, participants have completed Taxane-based breast cancer therapy within the last two years and have experienced neuropathy in the hands and feet frequently in the past seven days.
This is a Phase II trial

Massage to Reduce Pain and Increase Mobility After Breast Surgery

Massage for Pain and Mobility in Post-Breast Surgery Patients (NCT02250898)

Summary

Breast surgery can result in chronic pain and a lack of mobility in the chest and/or shoulder. Pain medication and/or physical therapy are often used to try to reduce this pain, but new methods are needed. Myofascial massage is a massage technique used to try to break up scar tissue. This type of massage may help reduce pain, inflammation and tissue sensitivity and increase mobility. This study is looking at whether myofascial massage to the breast, chest and shoulder area is more effective than a general relaxation body massage for reducing pain and increasing mobility in women who have had breast surgery. To be eligible, a woman must have had breast surgery within the previous 2-18 months.

Acupuncture To Treat Chemotherapy-Induced Neuropathy

Acupuncture to Prevent Chemotherapy Dose Reduction Due to Chemotherapy-induced Peripheral Neuropathy in Breast and Colorectal Cancer Patients (NCT01881932)

Summary

Peripheral neuropathy is a common side effect of chemotherapy. It usually includes pain, tingling, and numbness in the fingers and toes. This may cause a patient to receive a lower dose or a change of medication. Acupuncture, a technique used in traditional Chinese medicine, is commonly used to treat pain. Previous studies suggest that acupuncture could be effective in controlling neuropathy. This study will determine the effectiveness of using acupuncture to manage the pain, tingling and numbness caused by chemotherapy and if this treatment can help prevent reducing the dose of chemotherapy. To be eligible, participants must be receiving chemotherapy that includes a taxane or oxaliplatin and be experiencing symptoms of neuropathy.

Detecting and Monitoring Lymphedema

Evaluation of the Validity of BIS as a Tool for Quantification of Lymphedema Through Comparison With Perometry and Self-Report (NCT01544335)

Summary

Lymphedema is a painful swelling of the arm that can develop as a result of breast cancer treatment. Early detection and treatment of lymphedema may be able to help reduce or control this swelling. To improve early detection, better methods of measuring lymph fluid in the arm are needed. Bioimpedance spectroscopy involves using an extremely small electrical current to measure the amount of lymph fluid present in the arm. The goal of this study is to determine whether bioimpedance spectroscopy is as effective at detecting and monitoring lymphedema as a measurement device called a perometer. To be eligible, participants must be receiving follow-up care at Massachusetts General Hospital or the Dana-Farber/Harvard Cancer Center.

Scalp Cooling to Prevent Hair Loss Caused By Chemotherapy For Stage I-II Breast Cancer

Scalp Cooling for Alopecia Prevention (SCALP) (NCT01986140)

Summary

Hair loss is a common side effect of many chemotherapy drugs. Studies suggest that cooling the scalp during chemotherapy treatment may reduce hair loss. The Paxman Orbis Hair Loss Prevention System uses a soft lightweight silicone cap, which is placed on the patient’s head. The cap is connected to a small compact refrigeration system that applies cold temperature to the scalp during chemotherapy. The cold temperature numbs the scalp, which reduces blood flow and prevents chemotherapy drugs from reaching hair follicles. This study is evaluating the effectiveness and tolerability of using the Paxman Orbis Scalp Cooler to prevent hair loss during chemotherapy. To be eligible, participants must be planning to undergo treatment with anthracycline- or a taxane-based chemotherapy.
This is a Phase III trial

Treating Skin Irritation Caused by Radiation Treatment for Breast Cancer

Mometasone Furoate 0.1% Versus Eucerin on Moderate to Severe Skin Toxicities in Breast Cancer Patients Receiving Postmastectomy Radiation:A Randomized Trial, Double Blind Trial (NCT01856543)

Summary

Skin irritation is a common side effect of radiation therapy. Eucerin is an over-the-counter lotion that often is recommended during breast cancer radiation to prevent the treated skin from becoming dry or peeling. Mometasone furoate is a cream that is used to treat skin redness and irritation. This study is comparing the effectiveness Eucerin and mometasone furoate to treat skin irritation in women receiving radiation after a mastectomy. To be eligible, participants must have had a mastectomy for breast cancer and be planning to receive post-mastectomy radiation.
This is a Phase III trial

Glutamine for Chemotherapy-Related Neuropathy

A Randomized Placebo-Controlled Trial of Glutamine to Reduce the Signs and Symptoms of Peripheral Neuropathy in Breast Cancer Patients With a Mild Peripheral Neuropathy Receiving Paclitaxel Chemotherapy (NCT00195013)

Summary

Peripheral neuropathy is a common side effect of chemotherapy. It usually includes numbness, tingling, or painful feelings in the fingers and toes. Previous research has shown that the amino acid glutamine may help to prevent or reduce the development of these symptoms. The goal of this study is to further investigate the effect of glutamine on peripheral neuropathy and to figure out why people experience peripheral neuropathy after receiving chemotherapy. Participants must be receiving or have recently completed paclitaxel (Taxol®) or nab-paclitaxel (Abraxane®) chemotherapy.
This is a Phase III trial

Effect of NAC on Fatigue and Cancer Cells in Women with DCIS or Stage I Breast Cancer

Pilot Study of Anti-oxidant Supplementation With N-Acetyl Cysteine in Stage 0/I Breast Cancer (NCT01878695)

Summary

N-acetylcysteine (NAC) comes from L-cysteine, a naturally occurring amino acid. Oral forms of NAC can be purchased over-the-counter. An injectable (IV) form of NAC is used to protect the liver in cases of acetaminophen (Tylenol®) overdose. Studies suggest that NAC can reduce fatigue. Researchers are interested in seeing if it can reduce fatigue in women being treated for breast cancer. They are also interested in learning if NAC might have an effect on cancer cells. This study is looking at the safety of giving combined oral and IV NAC to patients with DCIS and stage I breast cancer. The researchers will study the effect that NAC has on cancer fatigue and on breast cancer cells.
This is a Phase I trial

Yoga to Reduce Fatigue During Radiation Therapy for Stage I-II Breast Cancer

A Randomized Study of the Effect of Yoga in Patients With Breast Cancer Receiving Radiation Therapy (NCT01985945)

Summary

Fatigue is a common side effect of radiation. Yoga has been shown to reduce fatigue as well as improve quality of sleep, physical vitality, and overall quality of life in women being treated for breast cancer. Eischens yoga incorporates ideas from movement theory and kinesiology and can be done by women with all body types and experience levels. It uses simplified poses that include sitting in a chair, standing and reclining. This study is looking at the effects that an 8-week Eischens yoga program has on women with stage I or II breast cancer who are receiving radiation therapy. To be eligible, participants must not have done yoga regularly in the last 6 months.

Yoga-Based Cancer Rehabilitation Program

Evaluation of a Yoga-Based Cancer Rehabilitation Program (NCT00179348)

Summary

Yoga may help to improve quality of life for individuals with cancer because it incorporates elements of relaxation, social support, and exercise. Benefits of yoga include improved mood, energy, memory, concentration, physical fitness, and decreased pain. This study compares a 12-week yoga intervention to standard care on quality of life among patients with early-stage breast, lung, and colorectal cancer. Participants must have been diagnosed with new or recurrent cancer within the past 5 years.

Using Cryotherapy (Cold) to Reduce Taxol-Related Neuropathy in Hands and Feet

Prevention of Paclitaxel Neuropathy With Cryotherapy (NCT02230319)

Summary

Paclitaxel (Taxol®) is a chemotherapy drug that is commonly used to treat breast cancer. One of the known side effects of Taxol is neuropathy—nerve damage that causes numbness, tingling, or painful feelings in the hands and feet. Previous studies have suggested that cold temperatures (cryotherapy) can provide relief from pain as well as delay the development of neuropathy. Elasto gel™ Hypothermia mitts and slippers deliver cold temperature to hands and feet. The purpose of this study is to see if Elasto gel™ Hypothermia mitts and slippers decrease the risk of neuropathy developing in patients undergoing weekly Taxol treatments. To be eligible, a patient must be scheduled to receive Taxol before or after breast cancer surgery.
This is a Phase II trial

Laser Treatment for Blood Vessels Affected by Radiation

Quality of Life Assessment in Breast Cancer Patients With Radiation-Induced Telangiectasias Treated With the Pulsed Dye Laser (NCT01803516)

Summary

Radiation treatments for breast cancer can have long-term effects on the skin. Telangiectasia–dilated blood vessels that can look like a red rash on the skin— is a common side effect. Pulsed dye laser is a heat treatment that may cause the blood vessels to become smaller and less visible. The purpose of this study is to see if receiving pulsed dye laser treatment for radiation-induced telangiectasias affects a woman’s overall well-being. To be eligible, participants must have been treated for breast cancer with surgery and radiation and developed radiation-induced telangiectasia.

Omega-3 Fatty Acids to Reduce Paclitaxel-Related Pain

A Pilot Randomized, Placebo Controlled, Double Blind Study of Omega-3 Fatty Acids to Prevent Paclitaxel Associated Acute Pain Syndrome (NCT01821833)

Summary

Omega-3 fatty acids are nutrients that are essential for good health. Omega-3 fatty acids are not made by the body; they are obtained through foods or supplements. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat breast cancer. One of it most common side effects is pain. Studies suggest that omega-3 fatty acids may help decrease Taxol-related pain. This study is looking at whether omega-3 fatty acids are better than a placebo for reducing pain. To be eligible, participants must be scheduled to receive treatment with the chemotherapy drug paclitaxel.

Coenzyme Q10 to Reduce Heart Damage from Adriamycin

Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer (NCT00976131)

Summary

Many women with breast cancer receive a chemotherapy regimen that includes the drug doxorubicin (Adriamycin®). However, women given doxorubicin may also experience some damage to their heart muscle. Coenzyme Q10 is a vitamin-like substance that helps cells convert the sugars in our food into energy that muscles can use. Researchers believe that Coenzyme Q10 may help to protect against heart damage during doxorubicin treatment. The goal of this trial is to study the safety and effectiveness of Coenzyme Q10 when taken during treatment with doxorubicin. To be eligible for this trial, participants must be scheduled to receive at least four cycles of doxorubicin.
This is a Phase I trial

Low-Calorie Diet To Reduce Side Effects of Chemotherapy

A Randomized, Phase II Clinical Trial of a Controlled Diet Prior to Selected Chemotherapy Treatment in Breast and Prostate Cancer to Evaluate the Impact on Toxicity and Efficacy (NCT01802346)

Summary

Chemotherapy drugs attack cells that are rapidly dividing, which is why they are an effective cancer treatment. However, other cells in the body that also divide rapidly, like those in the bone marrow, mouth, intestines, and hair follicles, are also likely to be affected by chemotherapy—which can lead to side effects. It is possible that eating a low-calorie diet may reduce chemotherapy-related side effects as well as improve how the tumor responds to treatment. This trial is investigating whether patients with early-stage breast cancer who eat a controlled low-calorie diet will have fewer side effects and a better response to chemotherapy than breast cancer patients who eat a normal diet. To be eligible, participants must be planning to receive chemotherapy treatment of AC (doxorubicin plus cyclophosphamide). (This trial also is enrolling men with prostate cancer.)
This is a Phase II trial

Preventing Nausea and Vomiting From Chemotherapy

A Pilot Study to Evaluate the Efficacy of Fosaprepitant and Granisetron Transdermal System for the Prevention of Acute and Delayed Nausea and Vomiting in Breast Cancer Patients and to Identify Predictors of Response (NCT01649258)

Summary

Nausea and vomiting are common side effects of chemotherapy. Antiemetic drugs may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Fosaprepitant dimeglumine, which is delivered via IV, and the granisetron transdermal system patch are both antiemetic drugs. Researchers believe combining the two will make them more effective. This study is investigating how well fosaprepitant dimeglumine and the granisetron transdermal system patch work to prevent nausea and vomiting in breast cancer patients undergoing chemotherapy.

Botox to Reduce Pain Caused by Expanders During Reconstruction

Botulinum Toxin A in Tissue Expander Breast Reconstruction: A Double-Blinded Randomized Controlled Trial (NCT01591746)

Summary

Breast reconstruction with implants is typically done in two stages. At the time of surgery, a temporary implant (tissue expander) is inserted, which over the course of several months is slowly filled with saline. A second surgery is then performed to replace the expander with a permanent implant. During expansion, patients often experience significant pain and discomfort. BTX-A (Botox) is currently used to reduce pain caused by migraine headaches and chronic tennis elbow as well as for post-operative pain control. This study will assess the safety and effectiveness of using Botox to reduce pain and improve physical well-being during tissue expansion. It is the first time Botox is being studied in breast cancer survivors who are having breast reconstruction with tissue expanders. To be eligible for this study, patients must be scheduled to have breast reconstruction following a skin-sparing or nipple-sparing mastectomy.
This is a Phase III trial

An Exercise Program for Stage I - III Breast Cancer Patients Starting Chemotherapy

Impact of a Physical Activity Program on Biomarkers of Aging During Adjuvant or Neoadjuvant Chemotherapy for Breast Cancer (NCT02167932)

Summary

Studies have shown that blood levels of p16—a biomarker of aging— increase dramatically during chemotherapy. Studies also have shown that cancer patients who exercise have lower p16 levels than those who do not exercise. Researchers believe that patients who take part in physical activity during chemotherapy will not have their p16 levels increase at the same rate as those who do not exercise. Walk With Ease is a walking program developed by the Arthritis Foundation that has been shown to help reduce fatigue and pain. This study is looking at whether the Walk With Ease program has an effect on p16 levels in women between the ages of 21 to 59 who have been diagnosed with stage I - III breast cancer. To be eligible, women must be scheduled to receive chemotherapy before or after their breast cancer surgery.

Other

Measuring Circulating Tumor DNA to Predict Treatment Response

Tumor Specific Plasma DNA in Breast Cancer (NCT01617915)

Summary

Researchers are trying to find a way to track a tumor's growth. Measuring circulating tumor DNA—DNA that shakes loose from a cancer cell and floats freely in the blood—may be a way to track this growth. It also may be possible to find markers in a tumor's DNA that help predict how a tumor will respond to a specific type of chemotherapy treatment. The purpose of this study is to determine whether changes in the levels of circulating tumor DNA can be linked to treatment response, and whether the presence of circulating tumor DNA following surgery provides information about which women with early-stage breast cancer are more likely to have a recurrence.

Using MRI of the Heart to Study Effects of Radiation Therapy for Left-Sided Breast Cancer

Prospective Pilot Study of Early Markers of Radiation-Induced Cardiac Injury in Patients With Left-Sided Breast Cancer Receiving Photon or Proton Therapy (NCT02199366)

Summary

Women who receive radiation therapy to treat breast cancer in their left breast are at risk of developing heart problems. Magnetic Resonance Imaging (MRI) scans produce detailed images of the inside of the body. This study is looking at whether MRI scans of the heart can identify changes in heart function that develop after radiation therapy. To be eligible, a patient must be scheduled to receive radiation therapy for a stage I-III left-sided breast cancer.
This is a Phase I trial

Effect of Chemotherapy on Fat Metabolism

The Effect of Chemotherapy on Fat Metabolism and Digestion and Function in Breast Cancer Patients. (NCT01890824)

Summary

Chemotherapy can cause breast cancer patients to gain fat and lose muscle. Studies have found that individuals who gain weight during chemotherapy are at increased risk of having a cancer recurrence. Losing muscle mass and function may cause fatigue and inactivity. Studying how the body digests, absorbs and metabolizes fat before and after chemotherapy can help researchers learn about the effect of cancer treatments on fat and muscle. This study will compare fat digestion, absorption and metabolism in breast cancer patients and healthy individuals. The researchers will use what they learn to develop an optimal nutritional program for breast cancer patients. To be eligible, participants with breast cancer must be planning to receive chemotherapy.

Assessing Cytokine Changes During Radiation

Cytokine Expression During Radiation for Breast Cancer (NCT00836186)

Summary

For reasons not yet understood, African American women with breast cancer have a greater risk of recurrence, are more likely to die of breast cancer, and experience worse toxicity and a worse cosmetic outcome than Caucasian women. Chemokines and cytokines are proteins and peptides that play a role in the cell signaling process. Studies have shown that certain chemokines and cytokines are associated with the development and progression of breast cancer, and researchers believe they may be a biological factor that is contributing in some way to the outcomes seen in African-American women. The purpose of this trial is to see whether women of different races and ethnicities have different levels of chemokines and cytokines while receiving radiation. Women of all races and ethnic groups planning on undergoing radiation treatment are eligible for this trial.

Learning Why Some Triple Negative Tumors Don't Respond to Chemo

Prospective Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients (NCT01276899)

Summary

Researchers want to learn which types of triple-negative breast cancer place women at higher risk for having a metastatic recurrence. This study will collect tissue and blood samples from women with triple negative tumors before and after they have chemotherapy. Researchers will use these tumor samples to evaluate how tumors are responding to therapy and to identify biological markers that are associated with different tumor types. This will help researchers develop better ways to treat women with triple-negative breast cancer.

Creating a Model to Study How Triple Negative Tumors Respond to Treatment

Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer (NCT02247037)

Summary

Researchers are trying to identify the best treatment for triple negative (ER-, PR-, HER2-) breast cancer. Giving chemotherapy before surgery (called neoadjuvant treatment) allows researchers to study how a tumor responds to a specific cancer therapy. Scientists are looking for new ways to develop models of triple negative tumors that they can use in the lab to study new drugs or new drug combinations. Placing tumor tissue taken from patients into mice is one way to study new treatments and treatment combinations. In this study, patients will donate tumor tissue for scientists to use to study triple-negative breast cancer. To be eligible for this study, a patient must be a candidate for neoadjuvant treatment and be undergoing surgery at a hospital that is part of the Mount Sinai Health System.

The Link Between Paclitaxel Drug Exposure and the Development of Peripheral Neuropathy

Defining an Exposure Target for Weekly Paclitaxel Infusion in Breast Cancer Patients (NCT02338115)

Summary

Peripheral neuropathy—pain, burning, tingling and numbness in the fingers and toes—is a common side effect of certain types of chemotherapy. Paclitaxel (Taxol®) is a chemotherapy drug commonly used to treat breast cancer. It is not known what level of drug exposure to Taxol increases the risk of a patient developing peripheral neuropathy. In this study, researchers will monitor blood level exposures of patients receiving Taxol and collect information about any neuropathy symptoms they develop during treatment. To be eligible, a patient must be scheduled to receive Taxol in the neoadjuvant or adjuvant setting.

Developing a Personalized Approach to Cancer Treatment

Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III) (NCT01334021)

Summary

Scientists are trying to develop ways to determine which cancer drugs will be most effective for which patients. In this study, the researchers will collect a tumor sample from women with HER2-negative breast cancer who have not yet had chemotherapy and/or hormone therapy, perform a genetic test on the tumor sample, and then follow the women for five years to see if their cancer recurs. The goal of the study is to see if the test the researchers have developed can predict how the tumor will respond to chemotherapy or hormone therapy. Because this is an investigational test, neither the doctor nor the participant will learn the test results or be able to use the results to make treatment decisions. To be eligible, participants must have a primary tumor that is at least 1 cm in diameter.

Studying the Effect of Chemotherapy on the Brain in Older Women

A Pilot Study of Structural and Functional Brain Magnetic Resonance Imaging Findings of Chemotherapy Toxicity in Older Women With Breast Cancer (NCT01992432)

Summary

Chemotherapy can cause short-and long-term difficulties with cognitive functioning, a problem often referred to as "chemo brain." Older adults may be at increased risk of developing cognitive problems from chemotherapy. This study will use advanced MRI techniques to characterize the changes that occur in the brain of women age 65 and older receiving adjuvant chemotherapy. Results of this study will lay the foundation for future, larger scale studies on the impact of chemotherapy on cognitive functioning in adults age 65 and older.

Neuropathy & Problems with Balance Following Taxane-Based Chemo and/or Radiation

The Effect of Taxane Chemotherapy on Balance in Breast Cancer Patients (NCT02391818)

Summary

Certain types of chemotherapy can cause peripheral neuropathy--weakness, numbness or pain in the hands and feet--which can increase the risk of falls or injury. Breast cancer patents who receive a taxane-based chemotherapy, such as ACT (Adriamycin®, Cytoxan®, Taxol®), are at increased risk of developing peripheral neuropathy. This study will evaluate balance problems that occur in patients receiving ACT and/or radiation therapy.

Studying Tumor-to-Breast Ratio in Patients with DCIS or Early-Stage Breast Cancer

A Prospective Trial to AssessTumor:Breast Ratio and Patient Satisfaction in Following Lumpectomy Versus Mastectomy With Reconstruction (NCT02216136)

Summary

The size of the tumor compared to the size of the breast is referred to as the tumor-to-breast volume ratio. The ratio is a factor in whether a woman has the option of having a lumpectomy. In this study, women who are scheduled to undergo lumpectomy, mastectomy, or mastectomy with immediate reconstruction for ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or early stage breast cancer will have a breast MRI that determines their tumor-to-breast volume ratio prior to surgery. After surgery, patients will complete questionnaires designed to assess their quality of life.

Evaluating the Effects of Chemotherapy on Ovarian Function

Multi-Center Study of Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer and Lymphoma (NCT00823654)

Summary

Breast cancer treatments can affect the ovaries, making it difficult for a woman to later conceive a child. They can also bring on early menopause. Ovarian functioning can be assessed by evaluating the blood levels of certain hormones the ovaries produce. The purpose of this study is to see how different cancer treatments affect the ovaries, and whether there are ways to predict which women will be more likely to go into early menopause. Women planning to have treatment with chemotherapy (CMF or ACT) or hormone therapy (tamoxifen) are eligible for this study. Women without cancer who are being treated at the NY Medical College/Center for Human Reproduction are also eligible.

A Study of the Relationship Between Chemotherapy and Intestinal Bacteria and Weight Gain

Changes in Intestinal Microbiota in Association With Chemotherapy Treatment (NCT02370277)

Summary

Breast cancer patients who gain weight during or after their cancer treatment are at increased risk of having a breast cancer recurrence. Chemotherapy drugs may change the gut bacteria in ways that make patients prone to weight gain. Researchers can study the effect that chemotherapy has on gut bacteria by analyzing the bacterial composition in a patient's stool sample. In this study, patients will provide stool samples for analysis before and after neoadjuvant (before surgery) or adjuvant (after surgery) chemotherapy. To be eligible, patients must have been diagnosed with DCIS or early-stage breast cancer and scheduled to have surgery at the Norris Comprehensive Cancer Center or Los Angeles County/University of Southern California Medical Center.

Donating Blood Samples to Help Researchers Develop a Blood Test to Look for Recurrence

A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer (NCT02270931)

Summary

Researchers want to develop a blood test that could predict recurrence or monitor how the tumor is responding to treatment. CA15-3 (Cancer Antigen 15-3) is a tumor marker that doctors currently use to monitor certain cancers. Researchers are trying to develop new ways to study CA 15-3 (assays) that are more accurate than those currently available. In this study, researchers will collect and evaluate blood samples over a three year period from women and men who have had a breast cancer diagnosis. They will use what they learn to develop new blood assays for monitoring recurrence or a tumor's response to treatment.

Ovarian Function After DCIS and Breast Cancer

Predictors of Ovarian Insufficiency Through Serial Exams in Young Breast Cancer Patients (POISE Study) (NCT01197456)

Summary

Premenopausal women may face issues related to having children as they undergo breast cancer care, and these concerns may influence their treatment choices. Tools that can accurately predict how treatment may affect ovarian function could help women and their doctors make choices that take into account the potential impact on fertility. The goal of this study is to identify pre-chemotherapy hormonal, genetic, and ovarian imaging markers that can predict whether a woman's ovaries are likely to continue to function at the end of her cancer treatments. Participants will be followed from the time of diagnosis to five years after treatment.

Tissue Sampling Bias for Sentinel Lymph Nodes

Tissue Sampling Bias in Histologic Evaluation of Sentinel Lymph Nodes in Breast Cancer (NCT01140763)

Summary

Researchers are interested in learning how often sentinel lymph nodes may contain small cancer deposits that might sometimes go undetected. The goal of this study is to completely analyze a series of lymph nodes that have been thinly sliced for microscopic examination. The information obtained from the study will help researchers assess how often small cancer deposits might be missed when the sentinel node is evaluated.

Immune System Response to Breast Cancer in Women Under Age 50

A Translational Study of the Interactions Between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction (NCT01503190)

Summary

Researchers are interested in learning more about the role the immune system plays in cancer. This study is looking specifically at the immune system in women with breast cancer who are under age 50. The researchers will look to see if differences in their immune system correspond to different types of tumors including tumors that develop during or after a pregnancy. The investigators may go on to use some of the breast cancer tissue collected in this study to create models that could be used to develop and test new drug treatments.

Studying the Effects of Cancer Treatment on the Heart

Cardiotoxicity of Cancer Therapy: Mechanisms and Predictors (NCT01173341)

Summary

Some drugs used to treat breast cancer can result in heart-related side effects. These include the class of chemotherapy drugs called anthracyclines (like doxorubicin/Adriamycin®) and the HER2-targeted therapy trastuzumab (Herceptin®). The goal of this trial is to identify factors that may help to predict which patients are most likely to experience heart-related side effects. To be eligible, participants must be planning to receive treatment with trastuzumab or an anthracycline-based chemotherapy regimen.

Johns Hopkins Breast Cancer Program Tissue Bank

Johns Hopkins Breast Cancer Program Longitudinal Repository (NCT01937039)

Summary

By studying cells in blood and breast tissue researchers hope to learn more about what causes breast cancer and how to treat it. The Breast Cancer Program at Johns Hopkins, in Baltimore, Maryland, has started a Longitudinal Repository—also known as a tissue bank. The Repository will store blood, breast tissue and urine samples donated periodically for up to 20 years by women with breast cancer or benign breast disease as well as healthy women. The Repository will provide blood, tissue, and urine samples donated by these women to breast cancer researchers. To be eligible, participants must be receiving care at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Treatment-Related Symptoms and Side Effects

Epigenetic Factors Associated With Symptoms and Complications of Chronic Disorders (NCT01411943)

Summary

Breast cancer patients who receive chemotherapy may experience symptoms such as depression, anxiety, pain, fatigue, trouble sleeping, and trouble concentrating or remembering things. Clinical studies suggest that chemotherapy increases the levels of inflammatory biomarkers, and some researchers believe that this inflammation may lead to genetic changes that make it more likely that women will experience treatment-related symptoms. The purpose of this study is see if there are treatment-related symptoms that are linked to specific inflammatory biomarkers or genetic changes that may occur in women being treated for early-stage breast cancer. To be eligible participants must enroll prior to starting chemotherapy for Stage I-IIIa disease.

Developing a Way to Predict Risk of Paclitaxel-Induced Peripheral Neuropathy

Validation of a Polygenic Neurotoxicity Risk Score in Patients With Unusually Severe Paclitaxel-Induced Neuropathy (NCT01953159)

Summary

Peripheral neuropathy—pain, tingling, and numbness in the fingers and toes—is a common side effect of chemotherapy. Collecting clinical data, blood samples, and self reported symptoms from patients given a paclitaxel-containing chemotherapy regimen may help researchers determine ways to predict who is at risk for developing peripheral neuropathy. This study is collecting blood samples from women who have been treated with a standard paclitaxel-containing chemotherapy regimen. It will include women with or without severe neuropathy.

Study of Persistent Post-Surgical Pain in Women With Early-Stage Breast Cancer

Biobehavioral Predictors of Persistent Post-Surgical Pain in Women Undergoing Breast Cancer Treatment (NCT02266082)

Summary

About half of all women who are treated for early-stage breast cancer experience persistent pain after surgery. In this study, researchers will investigate the relationship between biological factors (inflammatory biomarkers, stomach microenvironment, and pain sensitivity) and psychological effects (depression and anxiety) and pain in women with early-stage breast cancer. The study will also see if different types of surgery are more or less likely to be connected to the development of persistent pain. To be eligible, women must be scheduled to have breast surgery at the University of Florida Health/Shands Hospital in Gainesville, Florida.

Bone Mineral Density in Women Who Have Received Chemotherapy

Screening of Bone Mineral Density in Women Who Have Received Chemotherapy (NCT00603551)

Summary

Some breast cancer treatments have been shown to affect bone mineral density (BMD). Researchers think that chemotherapy may also decrease BMD by lowering estrogen levels and/or by directly affecting bone cells. Continued reduced bone mineral density may lead to osteoporosis and increase the risk of bone fracture. The purpose of this study is to determine the effect chemotherapy has on BMD. To be eligible, women must have either received their chemotherapy or follow-up care at the Hollings Cancer Center at the Medical University of South Carolina.

AVB-620 to Identify Tumor Tissue in Patients Having Surgery for Early-Stage Breast Cancer

A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery (NCT02391194)

Summary

Early-stage breast cancer is typically treated with surgery to remove all of the cancer. AVB-620 is a fluorescent marker designed to light up cancer tissue and make it easier for surgeons to see the tumor's borders. Giving patients AVB-620 could help surgeons remove the tumor with clean margins, reducing the need for a second surgery. This trial will identify the best dose of AVB-620 and the time needed for it to produce an optimal fluorescence signal on an imaging system. To be eligible, a patient must be scheduled to have a mastectomy or lumpectomy and a sentinel lymph node biopsy or axillary lymph node dissection.
This is a Phase I trial

Optical Spectroscopy in Evaluating Breast Tumor Margins

Optical Spectroscopy in Evaluating Tumor Margins in Patients Who Have Undergone Surgery for Breast Tumors (NCT00625417)

Summary

Currently, surgeons are not able to determine at the time of surgery whether they have removed an adequate amount of tissue surrounding the breast tumor. (This tissue is referred to as the margin.) Instead, they must wait for the results from the pathology tests performed on the tissue after the surgery has been completed. Researchers are trying to develop ways for surgeons to determine during surgery whether there are "clean" margins around the tumor. Previous studies have suggested that imaging devices can be used during surgery to determine whether there are cancer cells in the margin. Optical spectroscopy uses special instruments and a low power light to identify cancerous cells in body tissue. This goal of this study is to investigate whether optical spectroscopy is a device that surgeons can use during surgery to determine whether the margins around the tumor are clean. To be eligible, participants must be scheduled to have a breast lumpectomy, partial or radical mastectomy, or an excisional biopsy at Vanderbilt University Hospital.
This is a Phase I trial

Complementary and Alternative Medicine

Acupuncture to Reduce Side Effects in Breast Cancer Patients Receiving Taxol

Acupuncture to Reduce Chemotherapy-induced Peripheral Neuropathy Severity During Neoadjuvant or Adjuvant Weekly Paclitaxel Chemotherapy in Breast Cancer Patients: A Pilot Study (NCT02364726)

Summary

Acupuncture is a traditional Chinese medical technique that involves inserting very thin needles into specific points on the body. Studies suggest it can help reduce certain types of pain. Paciltaxel (Taxol®) is a chemotherapy drug used to treat breast cancer. One of the side effects associated with Taxol is numbness, tingling, or burning pain in the hands or feet. (This side effect is called peripheral neuropathy.) Acupuncture may be able to reduce this pain. This study is investigating whether weekly acupuncture reduces pain in women who are receiving a chemotherapy regimen that includes weekly Taxol before or after surgery to treat stage I-III breast cancer.

Glutamine Supplements to Prevent Radiation-Related Side Effects

Glutamine for the Prevention of Radiation Toxicity in Subjects Undergoing Breast (NCT02012608)

Summary

Radiation used to damage cancer in your body can also damage healthy cells. Glutamine is an amino acid that helps fuel cell division. Previous studies have found that glutamine supplements may help prevent or treat skin toxicity by promoting DNA or tissue damage repair to healthy cells. This study will compare the effects of glutamine and a placebo in patients with stage I or stage II breast cancer who are having accelerated partial breast radiation following a lumpectomy (breast conserving surgery) for their breast cancer treatment.
This is a Phase II trial

Vitamin D for Alaska Natives with Low Vitamin D Levels

Effect of Vitamin D Replacement on Tumor Response and Survival Parameters for Vitamin D Insufficient Patients With Cancer (NCT01787409)

Summary

Vitamin D protects bone and boosts the immune system. Studies suggest that people with low vitamin D levels may have a greater risk of developing cancer than those with higher vitamin D levels. Cholecalciferol (vitamin D3) is an artificial form of vitamin D. This study is investigating whether vitamin D3 improves survival in women newly diagnosed with breast cancer who have low levels of vitamin D. (Patients with other types of cancers are also being enrolled in this study.) To be eligible, breast cancer patients must be receiving treatment at the Alaska Native Medical Center, in Anchorage.

Effect of Omega-3 Fatty Acids Given Before Surgery on Breast Cancer Cells

A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma (NCT01869764)

Summary

Omega-3 fatty acids are essential nutrients for good health. They are not made by the body, and are obtained only through foods or supplements. Laboratory studies suggest omega-3 fatty acids can slow the growth of cancer cells. This study is comparing the effect of omega-3 fatty acids to the effect of a placebo on breast cancer cells. To be eligible, participants must be planning to have breast cancer surgery (lumpectomy or mastectomy) at least 7 days from the start of the study.
This is a Phase II trial