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Stage I-III Breast Cancer -- Triple Negative

Last updated: April 22, 2014


Chemotherapy

Eribulin Following an Incomplete Response to Neoadjuvant Chemo

Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy (NCT01401959)

Summary

If breast cancer cells remain in the breast or lymph nodes after preoperative (neoadjuvant) chemotherapy, the risk of recurrence may be higher. Eribulin (Halaven™) is a new chemotherapy drug that has been approved for the treatment of metastatic breast cancer that has not responded well to other chemotherapy drugs. The goal of this trial is to see if eribulin may also be an effective treatment for early-stage breast cancer that has not fully responded to standard neoadjuvant chemotherapy. In patients with HER2-positive breast cancer, eribulin will be combined with Trastuzumab (Herceptin®), a drug used to treat HER2-positive tumors.
This is a Phase II trial

Chemotherapy Before Surgery for Stage 3, 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® 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

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

Neoadjuvant Metronomic Chemotherapy for Triple Negative Tumors

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

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.

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.

Two Neoadjuvant Treatments for HER2-Negative Tumors

A Randomized Phase II Study of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer (NCT01527487)

Summary

Neoadjuvant therapy—treatment given prior to surgery—may shrink the size of a breast tumor, permitting less extensive surgery. It can also help determine if a cancer is responsive to a specific chemotherapy regimen. The chemotherapy combinations of eribulin/cyclophosphamide (ErC) and docetaxel /cyclophosphamide (TC) can each be used in the neoadjuvant setting. This trial is evaluating the toxicity profiles of these two different chemotherapy combinations when they are given to patients with locally advanced HER2-negative tumors. The researchers also are investigating whether the regimens are able to eliminate the tumor (this is known as a pathological complete response).
This is a Phase II trial

Comparing Chemotherapy Treatments After Surgery

Doxorubicin, Cyclophosphamide, and/or Paclitaxel in Treating Women With Nonmetastatic Breast Cancer (NCT00131963)

Summary

Chemotherapy drugs work in different ways to stop the growth of tumor cells. Some chemotherapy drugs kill the cancer cells; others stop the cells from dividing. For this reason, a combining chemotherapy drugs may be more effective than using one drug alone. This trial is comparing the safety and effectiveness of the combination of doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®) with the combination of doxorubicin, cyclophosphamide, and paclitaxel (Taxol®) in women with nonmetastatic breast cancer. To be eligible, women must be enrolled in clinical trial CALGB-40101 or meet the eligibility criteria.
This is a Phase II trial

Eribulin or Paclitaxel Plus Standard Chemo Before Surgery

A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2 (NCT01593020)

Summary

Researchers are trying to determine the most effective treatment for early-stage breast cancer. Giving chemotherapy before surgery, called neoadjuvant treatment, allows the researchers to study how the tumor is responding to the chemotherapy regimen. Eribulin (Halaven®) is currently used to treat metastatic breast cancer that has already been treated with two other types of chemotherapy. Studies suggest it may also be effective when used to treat early-stage breast cancer. Paclitaxel (Taxol®) is routinely used to treat early-stage breast cancer. This trial is comparing how tumors respond to a standard chemotherapy regimen when it is given before surgery along with Halaven or Taxol. The chemotherapy regimen will be selected by the patient's oncologist. It will be either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC). Both regimens are routinely used to treat early-stage breast cancer.
This is a Phase 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.

A New Patient-Controlled Tissue Expander for Reconstruction

AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction (NCT01425268)

Summary

As part of an implant reconstruction procedure, temporary tissue expanders are placed under the skin and muscle following the mastectomy. These expanders are used to stretch out the tissue and make room for the permanent breast implant. The expander is typically inflated over time, a process that requires the patient to go to the clinic to have a saline solution injected into the expander. The AirXpanders Tissue Expander System is a new patient-controlled breast tissue expander. It has a small handheld wireless controller that administers small amounts of CO2 into the device to stretch the skin. The goal of this trial is to compare the AirXpander Tissue Expander System to the traditional saline tissue expander. To be eligible, women must be planning to have breast reconstruction that requires tissue expansion.
This is a Phase II trial

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

Laser Therapy as an Alternative to Surgery for Small Tumors

A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers (NCT01478438)

Summary

Novilase Interstitial Laser Therapy (ILT) is an image-guided, minimally invasive alternative to a surgical lumpectomy. It works by destroying breast cancer cells. The goal of this study is to evaluate whether minimally invasive laser ablation of early-stage breast cancer is as effective as a traditional surgical lumpectomy. To be eligible, participants must have a tumor that is 2 cm or smaller.

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.

Improving Outcomes in Immediate Reconstruction With Implants

The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants (NCT01315119)

Summary

Many women who have a mastectomy to treat or prevent breast cancer prefer to have immediate reconstruction with implants rather than delayed reconstruction. However, immediate reconstruction is more likely than delayed reconstruction to result in complications such as infection, poor surgical incision healing, and tissue breakdown. Poor blood flow in the skin flaps that remain after removal of breast tissue may be the cause of these complications. SPY imaging is a new technology that creates high quality images of blood flow in tissue. It may be able to help reduce these complications by allowing surgeons to identify and eliminate areas of poor blood flow in mastectomy skin flaps. The goal of this trial is to study whether SPY imaging can be used during surgery to improve surgical outcomes for women who are having a mastectomy along with immediate reconstruction with implants.

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

Radiation oncology

Role of Beta-Endorphin in Radiation-Related Fatigue

Beta-Endorphin as a Mediator of Cancer Therapy-Induced Fatigue (NCT01113905)

Summary

Beta-endorphin is a substance that the body makes in response to pain or stress. This trial is investigating whether beta-endorphin may also play a role in causing the fatigue that cancer patients commonly experience as a result of radiation therapy. If it does, the researchers will then study whether agents that block beta-endorphin can be used to treat radiation-induced fatigue and improve the quality of life of patients undergoing radiation therapy. To be eligible, participants must be planning to receive radiation therapy at Massachusetts General Hospital.

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

Determining the Best Time for Reconstruction after Radiation

Effect of Radiation on Tissue for Delayed Breast Reconstruction (NCT01666899)

Summary

The best time to begin breast reconstruction when a patient has both a mastectomy and radiation is not yet known. The purpose of this study is to investigate the effects of radiation therapy following mastectomy by looking at samples taken from skin and blood vessels at various times after mastectomy. The investigators will look at various properties of the skin including its blood flow to determine an ideal time for breast reconstruction.To be eligible, patients must be planning to have a mastectomy, post-mastectomy radiation, and post-mastectomy breast reconstruction.

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 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.

Studying Cognitive Changes Before and After Radiation Therapy for Brain Metastases

A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases (NCT01445483)

Summary

Radiotherapy is the most frequently used therapy for breast cancer brain metastases. However, cognitive dysfunction may be a side effect of this treatment. Currently there are no standardized tests to measure changes in cognitive functioning in patients treated for brain metastasis. In this trial, researchers will test a patient's memory, attention, processing speed, and reading and fine motor skills before and after radiation therapy to the brain to find out if this treatment causes a change in patients' cognitive and daily functioning.

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.

An Accelerated Radiation Schedule for Early-Stage Disease

Higher-Dose Radiation Therapy or Standard Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery (NCT01349322)

Summary

Lumpectomy followed by radiation is a standard treatment for DCIS and early-stage breast cancer. Standard radiation therapy usually involves 3 to 5 weeks of whole breast radiotherapy (WBI) followed by 2 weeks of a radiation “boost” directed to the lumpectomy site. An accelerated WBI schedule gives higher daily doses of radiation over a shorter period of time. The goal of this study is to see if an accelerated schedule that gives the radiation boost to the lumpectomy site at the same time as the higher levels of WBI is as effective as standard WBI followed by the radiation boost. To be eligible, participants must have DCIS or Stage I or II breast cancer and be planning to receive radiation therapy following a lumpectomy.
This is a Phase III trial

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

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

4D Image-Guided Radiation in DCIS and Stage l Breast Cancer

A Pilot Study of Four-Dimensional Conformal Image Guided Accelerated Partial Breast Irradiation In The Treatment Of Stage 0 and l Breast Cancer (NCT01646346)

Summary

Radiologists are trying to find new technologies that can deliver radiation that targets the tumor cells and avoids nearby healthy tissue and organs. Image guidance and four-dimensional computed tomography (4D CT) makes CT scans much faster and more accurate. It takes images that capture the location of the tumor, and it adjusts for movement of the tumor or the body's organs. When used with Accelerated Partial Breast Irradiation (APBI), image guidance and 4D CT may be able to decrease radiation exposure to healthy tissue. This study is evaluating the feasibility of using image guidance and 4D CT during radiation therapy given to women with ductal carcinoma in situ (DCIS) or stage I breast cancer.

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.

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

Accelerated Radiation Schedule After Mastectomy

Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial (NCT01417286)

Summary

Radiation therapy is used to kill any cancer cells that may remain after surgery. It may be recommended after a mastectomy if the tumor is large and/or cancer cells have been detected in the lymph nodes. Radiation therapy is typically given 5 days a week for 5 to 7 weeks. Accelerated hypofractionated radiation therapy 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, side effects, and cosmetic outcome of an accelerated radiation schedule in women with Stage II-III breast cancer who have had or are planning to have a mastectomy. Participants must enroll in the study within 9 weeks of their mastectomy, or within 9 weeks of completing chemotherapy after a mastectomy.
This is a Phase II 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

Accelerated Partial Breast Radiation Before Lumpectomy

Preoperative Accelerated Partial Breast Irradiation (APBI) for Women With Stage I and Select IIA Breast Cancer (NCT01014715)

Summary

Women who have a lumpectomy typically receive six to seven weeks of daily radiation to the entire breast after surgery. Accelerated partial breast radiation is a faster method of delivering radiation. It is administered over several days to the affected part of the breast. The goal of this trial is to determine the effectiveness and cosmetic results of accelerated partial breast radiation that is given before lumpectomy. By administering radiation before the lumpectomy, researchers believe that a smaller amount of breast tissue may be exposed to radiation. To be eligible, women must have stage I or IIa disease (a tumor smaller than 3 cm) and must be planning to receive a lumpectomy.
This is a Phase II trial

Radiation "Boost" for Stage 0-II Tumors in the Prone Position

Prospective Trial of Two Prone Breast Radiotherapy Techniques With Randomization to Concurrent Versus Weekly Boost (NCT01591811)

Summary

Radiation to the breast is a standard part of the treatment for DCIS or early-stage breast cancer. It is given after surgery to the whole breast for about five weeks, followed by a "boost "delivered to the tumor site for about one week. The radiation is typically delivered with the patient lying on her back. Having the patient lay on her stomach (called a "prone" position) decreases the amount of radiation to the lung, heart, and other breast. This trial will compare the safety and effectiveness of giving the "boost" daily or weekly when the woman is lying on her stomach (prone).
This is a Phase III 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

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

Taxol & LCL 161 Before Surgery For Triple Negative Tumors

A Phase II Multi-center, Open-label, Neoadjuvant, Randomized Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer (NCT01617668)

Summary

Giving treatment before surgery (called neoadjuvant therapy) allows researchers to study how the tumor responds to the treatment. Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. LCL161 is an investigational drug that interferes with proteins that keep cancer cells from dying. Laboratory studies have shown that LCL161 can kill triple negative breast tumors (ER, PR and HER2-negative). This trial is looking at how triple negative tumors respond to Taxol when it is given alone or with LCL161 prior to surgery. The researchers will also look at whether LCL161 is more effective in women whose tumors have a specific gene expression profile they are studying.
This is a Phase II 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

Tumor Response to Reparixin, a Drug that Targets Cancer Stem Cells

A Single Arm, Preoperative, Pilot Study to Evaluate the Safety and Biological Effects of Orally Administered Reparixin in Early Breast Cancer Patients Who Are Candidates for Surgery (NCT01861054)

Summary

Cancer stem cells (CSCs) are the small number of cells within a tumor that fuel its growth and spread. Chemotherapy and radiation are not able to kill CSCs, which may be one reason why a cancer recurs or spreads after treatment. Reparixin is an oral drug that targets CSCs. This study will compare the effect reparaxin has on triple negative (ER, PR and HER2-negative) tumors with its effect on ER or PR+, HER2-negative tumors by giving it to patients after their breast cancer diagnosis and before surgery.
This is a Phase II trial

Taxol® and Cytoxan® 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

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

Chemo & Herceptin® for Tumors With Low HER2 Expression

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer (NCT01275677)

Summary

Trastuzumab (Herceptin®) is used routinely to treat individuals with HER2-positive tumors. However, studies suggest that Herceptin may also be an effective treatment for tumors that express low levels of HER2. (A tumor has a low level of HER2 if it has an IHC test score of 1+ or 2+.) Currently, tumors that express low levels of HER2 are treated with combination chemotherapy. The purpose of this trial is to find out if it is beneficial to add Herceptin to a standard chemotherapy regimen given after surgery to individuals with tumors with low HER2 expression.
This is a Phase III 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

Veliparib & Chemo Before Surgery for Triple Negative Tumors

An Adaptive, Randomized Phase II Trial to Determine Pathologic Complete Response With the Addition of Carboplatin With and Without Veliparib to Standard Chemotherapy in the Neoadjuvant Treatment of Triple-Negative Breast Cancer (NCT01818063)

Summary

Giving chemotherapy or targeted therapy before surgery (called neoadjuvant treatment) allows researchers to see whether the therapy shrinks the tumor or makes it disappear. Veliparib is a new type of targeted therapy known as a PARP inhibitor. It causes cancer cells to die by keeping them from repairing DNA damage. Paclitaxel (Taxol®), carboplatin (Paraplatin®), doxorubicin (Adriamycin®), and cyclophosphamide (Cytoxan®) are chemotherapy drugs used to treat breast cancer. Studies suggest that giving veliparib along with chemotherapy may be more effective than giving chemotherapy alone. This study is investigating whether giving veliparib along with Taxol and Paraplatin followed by Adriamycin and Cytoxan is more effective than giving these chemotherapy combinations alone to women with stage IIB or stage III triple-negative breast cancer.
This is a Phase II trial

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.

Ritonavir's Effects on Breast Cells Before Surgery

A Phase I/II Trial of Short Course Pre-Operative Ritonavir To Determine Akt Inhibition in Breast Cancer (NCT01009437)

Summary

Researchers believe that some of the anti-retroviral drugs used to treat HIV may also be effective cancer treatments. Ritonavir (Norvir®) is an anti-retroviral drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cancer cell growth. The goal of this study is to learn more about the effects of ritonavir on biomarkers (substances found in blood and tissue) involved in breast cancer growth. To be eligible for this trial, participants must be planning to undergo surgery for newly-diagnosed breast cancer.
This is a Phase I-II trial

Herceptin® Before Surgery For Tumors With Low HER2 Expression

Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC) (NCT00944047) (NCT00944047)

Summary

Trastuzumab (Herceptin®) is used routinely to treat individuals whose tumors are HER2-positive. However, studies suggest that Herceptin may also be an effective treatment for tumors that express low levels of HER2. (A tumor has a low level of HER2 if it has an IHC test score of 1+ or 2+.) Currently, tumors that express low levels of HER2 are treated with combination chemotherapy that is given either before or after surgery. The purpose of this trial is to find out if it is beneficial to add Herceptin to standard chemotherapy given before surgery to individuals with tumors with low HER2 expression.
This is a Phase II trial

Valproic Acid Before Surgery for Breast Cancer

Molecular Signature of Valproic Acid in Breast Cancer With Functional Imaging Assessment - a Pilot (NCT01007695)

Summary

Testing a new treatment before surgery allows researchers to observe how well a tumor responds to the new therapy. Laboratory studies have shown that breast cancer cells respond to drugs that inhibit a protein called histone deacetylase (HDAC). Valproic acid (Depakote®) is a histone deacetylase inhibitor that may be an effective breast cancer treatment. It is currently approved to treat seizures and to prevent migraines. The goal of this trial is to determine the effect valproic acid has on the HDAC protein in breast cancer cells when it is given for a short period of time before surgery. To be eligible, participants must have a tumor that is at least 1.5cm and be planning to undergo surgery or be willing to have a biopsy at the end of the trial.
This is a Phase I 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

Vaccine for Stage II and III Breast Cancer with The WT1 Protein

Study of GSK2302024A Antigen-Specific Cancer Immunotherapeutic Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer (NCT01220128)

Summary

High levels of a protein called WT1 have been found to be associated with the development of certain types of cancer. Recent studies have found that WT1 also is present in some breast cancer tumors. This trial is studying the safety and clinical activity of an experimental cancer treatment vaccine that works by triggering an immune response to the WT1 protein. The vaccine will be given before surgery in combination with standard therapy to patients with stage II or stage III breast cancer. To be eligible, tumors must test positive for the WT1 antigen.
This is a Phase II trial

Other treatment

Laser Interstitial Thermal Therapy to Treat Small, Node-Negative Tumors

A Pilot Study to Evaluate Magnet Resonance Thermal Imageguided Interstital Thermal Therapy for Focal Ablation of Breast Cancer (NCT01791998)

Summary

Small breast tumors are typically treated with surgery. Magnetic resonance thermal image guided laser interstitial thermal therapy (LITT) is a technique that uses laser heat treatment to destroy cancer cells. An alternative to surgery, it is approved for the treatment of brain and other types of cancers. This is a pilot study to investigate the use of LITT to remove breast tumors that are less than 1.5 cm in diameter and have not spread to the lymph nodes.

Vitamin D Before Surgery for Breast Cancer

Vitamin D and Breast Cancer in Obesity: Therapeutic Trials (NCT01472445)

Summary

Vitamin D is an essential nutrient for bone health, calcium absorption, and immune function. Researchers believe that vitamin D may have an effect on breast cancer cells, and that this effect may be even greater in women with breast cancer who are obese. This study will investigate whether giving vitamin D prior to surgery can change the tumor's gene expression pattern from high-risk to low-risk. The researchers will also investigate whether these pattern changes occur in the same ways in obese and non-obese women. To be eligible, participants must be planning to have surgery for breast cancer but have not yet had any treatment.

Effect of Vitamin D3 During Breast Cancer Treatment

Vitamin D3 (Vit D3) Supplementation and T Cell Immunomodulation in Patients With Newly Diagnosed Operative Invasive Ductal Breast Carcinoma Stage I-II (NCT01816555)

Summary

Studies have suggested that women who have low levels of vitamin D3 are at greater risk of being diagnosed with breast cancer or having a breast cancer recurrence. Researchers think this may be because of the effect vitamin D has on the immune system's T cells. In this study, researchers will measure the number of T cells a woman being treated for breast cancer has before, during, and after two months of taking vitamin D3. To be eligible, participants must be newly diagnosed with stage I or stage II breast cancer.

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

Diagnostic

Study of Chemotherapy Drug Delivery

A Pilot Study of F-18 Paclitaxel (FPAC) PET for Evaluating Drug Delivery of Solid Tumors in Breast, Lung, Renal, and Adrenal Cancers (NCT01086696)

Summary

Paclitaxel (Taxol®) is a commonly used breast cancer treatment. Tumors can, however, become resistant to paclitaxel. When this occurs, the tumors stop accumulating the amount of paclitaxel necessary to kill the cancer cells. To study how tumors become resistant to paclitaxel, researchers must be able to see how much paclitaxel is absorbed by the tumor cells. 18F-Fluoropaclitaxel (FPAC) is a form of paclitaxel that has been modified to be slightly radioactive so that it will show up on positron emission tomography (PET) scans. By injecting a very small amount (much less than that used to treat tumors) of the radiolabeled drug into the body, researchers hope to use PET scans to evaluate the amount of the drug absorbed by tumors. The goal of this trial is to see if this FPAC shows up on PET scans. To be eligible, participants must have a tumor in their upper torso that is at least 1 cm in size.

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.

Optical Spectroscopy for Diagnosing Breast Cancer

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy (NCT00734838)

Summary

Optical spectroscopy uses special instruments and a low power light to identify cancerous cells in body tissue. It currently is used to detect a number of different types of cancer. This study is investigating whether it is an effective tool for identifying breast cancer cells. To be eligible, individuals must be scheduled to have a mastectomy or lumpectomy, or be scheduled to have a biopsy because their mammogram suggests they have a high likelihood of having breast cancer.

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.)

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.)

Studying Disseminated Cancer Cells Before and After Chemotherapy

Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells (NCT00353483)

Summary

Single tumor cells or small groups of tumors cells that are found in the lymph or blood are often referred to as disseminated tumor cells (DTCs). Chemotherapy that is given before surgery may not kill all cancer cells. DTCs that are not killed by chemotherapy are believed to have a unique set of tumor marker proteins. This study will compare the tumor markers seen on DTCs detected prior to chemotherapy to the tumor markers seen on any DTCs present after chemotherapy. This will help the researchers determine whether the tumor markers on DTCs can be used to predict which patients are most likely to have a breast cancer recurrence. To be eligible, participants must be planning on receiving chemotherapy before surgery.

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.

PEM Imaging for Second Tumors Found on MRI Before Surgery

Clinical Value of Pre-Surgery Positron Emission Mammography (PEM) in Patients With Newly Diagnosed Breast Cancer (NCT01241721)

Summary

Positron Emission Mammography (PEM) is a newly developed imaging technique that uses a radioactive glucose based tracer (a form of sugar attached to a low radiation agent) to detect cancer cells. The tracer is called fluorodeoxyglucose (FDG). PEM and FDG have been approved by the FDA. Studies suggest that PEM may be as good as or better than Magnetic Resonance Imaging (MRI) at detecting breast cancer. This study will first determine the lowest dose of radionuclide 18F-FDG that can be used with PEM. The lowest dose will then be used to image second breast cancers that have been identified by MRI in newly diagnosed breast cancer patients wishing to have breast conservation surgery. To be eligible, participants must have had a breast MRI and have an unsuspected second lesion recommended for biopsy.

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

Supportive

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

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.

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.

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

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.

Couples Counseling for Breast Cancer Patients

Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer (NCT00940277)

Summary

Breast cancer treatment can be physically and emotionally demanding for both patients and their partners. The goal of this study is to determine the value of two counseling interventions developed to reduce the psychological distress on patients and their partners during and after the breast cancer experience. Both patients and their partners will participate in the counseling interventions. Couples must be married or co-habitating.

Enalapril to Protect the Heart from Side Effects of Doxorubicin

The Effect of Enalapril on Doxorubicin Exposure in Adjuvant Breast Cancer Treatment (NCT00895414)

Summary

Doxorubicin (Adriamycin®) is a standard breast cancer chemotherapy treatment. It is effective, but it can also cause heart damage. Enalapril maleate (Vasotec®) may help protect heart cells from the side effects of doxorubicin. It is not yet known whether it is more effective to give enalapril maleate before or after the doxorubicin. The main purpose of this study is to investigate whether there is a drug interaction that occurs between enalapril and doxorubicin and whether enalapril has any effect on how doxorubicin is metabolized. To be eligible, participants must be planning on receiving treatment with doxorubicin.

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

Acupuncture to Reduce Chemotherapy Related Side Effects in Early-Stage Breast Cancer

The Efficacy of Acupuncture in Treating Chemotherapy Side Effects in Breast Cancer Patients (NCT01996410)

Summary

Acupuncture is a treatment that involves inserting sterile, hair-thin needles into specific points on the skin. Studies have found that acupuncture can help relieve fatigue, hot flashes, nausea, vomiting, and pain. Researchers believe this is because acupuncture stimulates the nervous system. This study is investigating whether acupuncture can reduce symptoms associated with chemotherapy, such as nausea, vomiting, fatigue, anxiety, anorexia, pain, disturbed sleep, shortness of breath, dry mouth, depression, and peripheral neuropathy. To be eligible, a patient must be planning to receive chemotherapy to treat stage I - III breast cancer.

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

Healing the Incision Made During a Nipple-Sparing Mastectomy

A Prospective, Multi-Center, Randomized, Open Label Controlled Trial Using a Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy (NCT01796977)

Summary

During a nipple-sparing mastectomy the breast tissue is removed through a small incision below the nipple. This allows the surgeon to spare all of the breast skin, including the nipple and areola. A dressing is put over the incision to aid with healing. OxyGenesys Dissolved Oxygen Dressing (ODOD) is a new type of dressing that provides oxygen bubbles directly to the site of the incision. These oxygen bubbles may help the incision to heal better. The goal of this study is to evaluate the effectiveness of ODOD for healing the incision made during a nipple-sparing mastectomy. To be eligible for this trial, a woman must be planning to have a bilateral nipple-sparing mastectomy with immediate breast reconstruction because she has breast cancer or because she carries a BRCA genetic mutation.

Aleve or Claritin w/ Neulasta to Reduce Bone Pain During Chemo

Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim (NCT01712009)

Summary

One of the most common side effects of chemotherapy is short-term damage to the bone marrow that interferes with its ability to make blood cells. This is called bone marrow suppression (or myelosuppression) and it can cause bone pain. This study is investigating whether using the non-steroidal anti-inflammatory drug naproxen (Aleve®) or the anti-histimine loratadine (Claritin®) can reduce the incidence and/or severity of bone pain in breast cancer patients receiving chemotherapy.
This is a Phase II 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

Smoking Cessation Prior to Mastectomy & Reconstruction

Treatment of Tobacco Dependence in Breast Cancer Patients Scheduled for Mastectomy/Reconstructive Surgery: A Randomized Trial of Varenicline (Chantix) (NCT01532232)

Summary

Breast cancer patients who smoke are at greater risk for treatment complications, especially if they are scheduled for surgery. The purpose of this study is to investigate the effectiveness and impact of varenicline, a prescription medicine also known as Chantix®, in helping breast cancer patients quit smoking. All patients will also receive smoking cessation counseling provided by a tobacco treatment specialist. To be eligible, participants must have smoked an average of 10 cigarettes per day for the past year and be planning to have a mastectomy with reconstruction at Memorial Sloan Kettering Cancer Center in New York City.

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

Reducing Risk of Lymphedema from Axillary Node Dissection

Reducing Extremity Lymphedema Through Axillary Lymphatic Preservation (NCT00932035)

Summary

A potential risk associated with Axillary Lymph Node Dissection (ALND) is lymphedema, a painful swelling of the arm that is caused by faulty drainage of the lymph nodes. Axillary Reverse Mapping (ARM) is a procedure that uses an injectable blue dye to evaluate the ways in which fluid drains through the lymph node system. Researchers believe that using ARM to identify and preserve lymphatic channels and nodes draining the arm when performing an ALND may reduce lymphedema, resulting in an improved quality of life.
This is a Phase I-II trial

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.

Calcium and Magnesium for Preventing Taxane-Induced Neuropathy

Calcium and Magnesium Infusion for the Prevention of Taxane Induced Neuropathy in Earlier Stage Breast Cancer (NCT01682499)

Summary

Neuropathy is the medical term for pain or discomfort in the hands and feet caused by damage to the nerves of the peripheral nervous system. It is a potential side effect of the taxane drugs used in many chemotherapy regimens. There are currently no effective ways to treat or prevent taxane-related neuropathy. Previous studies have found that calcium and magnesium infusions can decrease the incidence and intensity of neuropathy symptoms. This study will evaluate the feasibility of giving an intravenous calcium and magnesium (Ca/Mg) infusion to help prevent taxane-induced neuropathy to patients with early stage breast cancer who are receiving paclitaxel (Taxol®).
This is a Phase I trial

Electroacupuncture to Reduce Nerve Pain Caused by Taxol®

Randomized Sham Controlled Trial of Weekly Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy (NCT01163682)

Summary

The chemotherapy drug paclitaxel (Taxol®) is a widely used effective breast cancer treatment. However, one of its common side effects is nerve and muscle pain. Acupuncture is a technique used in traditional Chinese medicine that involves the insertion of hair-thin needles into various points in the skin. Electroacupuncture is a form of acupuncture in which pairs of acupuncture needles are attached to a device that generates electrical pulses between them. Studies have shown that it can help to relieve pain. This trial is investigating whether giving electroacupuncture during paclitaxel treatment can help to prevent or decrease nerve pain. To be eligible, participants must be planning to receive weekly paclitaxel for 12 weeks after surgery for early-stage breast cancer and must never have received acupuncture treatment.
This is a Phase I trial

Intellectual Impairment in Women With Breast Cancer

Assessment and Treatment of Cognitive Deficits in Breast Cancer (NCT00896324)

Summary

Breast cancer and its treatment may cause changes in a woman's ability to think, learn, and remember. Gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment. The goal of this trial is to study intellectual impairment in women with breast cancer who may or may not have received chemotherapy. This trial is also comparing the effectiveness of two intervention programs designed to prevent or reduce cognitive difficulties associated with chemotherapy treatment. The researchers are also enrolling women who have never had breast cancer to participate in this study.
This is a Phase I trial

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.

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

Health Problems Following a Breast Cancer Diagnosis and Treatment

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) (NCT00027118)

Summary

Breast cancer and its treatments can affect women in many different ways. Researchers are interested in learning more about the physical problems, functional limitation, and loss of independence women face following a breast cancer diagnosis and treatment. In this study, women who have been diagnosed with breast cancer will be interviewed and examined every three to six months through two years after the completion of treatment. The researchers will compare the women with breast cancer to healthy women who had a breast biopsy that was negative for breast cancer. This will allow them to study the effects breast cancer and its treatment have over time. To be eligible, women must be treated at the National Naval Medical Center in Bethesda, MD.

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.

A New Treatment for the Management of Neutropenia

Phase 2, Open-Label, Dose-Ranging Study of HM10460A or Pegfilgrastim Use for the Management of Neutropenia in Patients With Breast Cancer Who Are Candidates for Adjuvant and Neoadjuvant Chemotherapy With the Docetaxel + Cyclophophamide (NCT01724866)

Summary

Neutropenia is an abnormally low count of neutrophils, a type of white blood cell that helps fight off infections. About half of all people who receive chemotherapy develop some degree of neutropenia. Pegfilgrastim (Neulasta®) is the drug that is currently used to prevent neutropenia. HM10460A is a new medication that can be given less frequently and at a lower dose than Neulasta. This study is comparing HM10460A to Neulasta to see which does a better job of reducing severe neutropenia. To be eligible, participants must be a candidate for docetaxel (Taxotere®) and cyclophosphamide (Cytoxan®) chemotherapy.
This is a Phase II trial

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.

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.

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.

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

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

Assessing Changes in the Brain Before & After Chemotherapy

Feasibility Study of Vascular and Cognitive Assessments During Adjuvant Chemotherapy for Breast Cancer (VASCOG) (NCT01483196)

Summary

Some types of breast cancer treatment can affect a patient's memory, resulting in a condition often referred to as "chemo brain" or "chemo fog." Two tests that allow researchers to assess changes occurring in the brain–Transcranial Doppler ultrasound (TCD) and Magnetic Resonance Imaging (MRI)—may help us to better understand why chemo brain occurs. In this trial, patients will have TCD and MRI before chemotherapy has started and after it has ended so that the researchers can assess what brain changes may have occurred during this time period.

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.

Cold Cap for Preventing Hair Loss During Chemotherapy

Clinical Performance, Efficacy and Safety of the DigniCap™ System, a Scalp Hypothermia System, in Preventing Chemotherapy Induced Alopecia in Patients With Early Stage Breast Cancer (NCT01831024)

Summary

Hair loss is a side effect of many chemotherapy drugs. The Dignicap™ system uses cold to numb the scalp during chemotherapy. The cold reduces blood flow to the scalp, which may keep the chemotherapy drug from harming the hair follicles. This study is evaluating the effectiveness and tolerability of using the DigiCap System to prevent hair loss during chemotherapy. To be eligible, women must be planning to have chemotherapy before or after surgery as part of their breast cancer treatment.

A Walking Program for Older Patients Receiving Chemotherapy

Feasibility of an Evidence-based Walking Program in a Sample of Cancer Patients >60 Years of Age Undergoing Cytotoxic Chemotherapy (NCT01789983)

Summary

People who spend time walking over the course of their chemotherapy treatments may have an improved quality of life during their cancer care. This is a pilot study testing a medium-intense walking program called Walk With Ease in cancer patients age 60 and older who are starting chemotherapy. Researchers will look at biomarkers of aging in the blood and also measure how many participants complete the program. Results from this study will be used to help design future studies of the Walk With Ease program. This study is enrolling women and men scheduled to receive chemotherapy for any type of cancer.

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

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.

F-627 to Prevent Neutropenia (Low White Blood Cell Count)

A Phase II, Randomized, Multi-Centre, Open-Label, Active-Controlled, Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy (NCT01648322)

Summary

Chemotherapy can cause neutropenia--a dangerously low white blood cell count that increases the risk of infection. Pegfilgrastim (Neulasta®) is given along with chemotherapy to keep neutropenia from developing. F-627 is a new drug that may help the body make white blood cells faster than Neulasta does. This study is comparing the effectiveness and safety of two different doses of F-627 with Neulasta. To be eligible, participants must be diagnosed with stage II or III breast cancer and scheduled to have four cycles of the chemotherapy regimen taxotere and cyclophosphamide (TC).
This is a Phase II trial

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

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

Varenicline for Cigarette Smoking Among Cancer Patients

Extended Duration Varenicline for Smoking Among Cancer Patients: A Clinical Trial (NCT01756885)

Summary

Stopping smoking is critical for persons who have been diagnosed with cancer because continued smoking after diagnosis has been found in prior research studies to be associated with decreased survival time, reduced effectiveness of cancer treatments, and decreased quality of life. This trial, which is located within the Department of Preventive Medicine in the Feinberg School of Medicine, is now offering a clinical research study that is evaluating a new smoking cessation intervention tailored to cancer patients and survivors. Eligible smokers will receive seven sessions of smoking cessation counseling and receive varenicline (Chantix), a U.S. Food and Drug Administration (FDA)-approved smoking cessation medication – all at no charge.
This is a Phase III trial

Genetics

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 
Education

Teaching Patients and Caregivers to Give a Neulasta Injection

A Comparison of Strategies for Injection Teaching: Verbal and Written Instruction Versus Verbal and Written Plus Simulation in Patients With Breast Cancer and Their Caregivers (NCT01829984)

Summary

Many breast cancer patients receive pegfilgrastim (Neulasta®) after receiving chemotherapy to prevent or treat neutropenia—a low white blood cell count that increases the risk of infection. Neulasta is typically given by injection one day after a dose of chemotherapy. Currently, patients and caregivers are given written and verbal instructions on how to give the injection. This study is investigating whether having patients and caregivers practice giving the injections after they receive the verbal and written instructions is a better way to provide this information. To be eligible, participants must be receiving or planning to receive Neulasta a day after they receive chemotherapy.

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.

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.

Epidemiology

A Questionnaire to Assess Cancer Symptoms by Mail or Phone

The NCl Community Cancer Center Program Patients Reported Symptom Surveillance and Disparities Study (NCT01547845)

Summary

Cancer and cancer treatments can cause symptoms and side effects such as pain, fatigue, and emotional distress. Collecting and comparing patient data from multiple cancer care centers will help researchers better understand patients' experiences. This study is piloting a method for collecting patient reports of symptom-related experiences, with the goal of using this information to improve cancer treatment at hospitals and other care centers. To be eligible, patients must have had a Stage I-III breast cancer diagnosis between February 2011 and May 2012.

A Study of Working Women and Breast Cancer

A Pilot Study of Working Women and Breast Cancer (NCT01914614)

Summary

A breast cancer diagnosis can have an impact on a woman's work life. Researchers are studying how workplace factors influence breast cancer patients' ability to adhere to recommended cancer treatment and effectively recover from cancer. This study will survey women about their experiences in managing cancer while taking care of their job responsibilities. To be eligible, a woman must be receiving breast cancer care at the University of Kentucky Markey Cancer Center in Lexington.

Effect of Regional vs. General Anesthesia on the Immune System

Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer (NCT01716065)

Summary

There are two different types of anesthesia that can be used during breast cancer surgery. The first is general anesthesia—when a person "goes to sleep" with a breathing tube and then receives intravenous (IV) pain medicine during and after surgery. The second is regional anesthesia–when patients receive a nerve block to the breast area along with heavy IV sedation and take a "deep nap" during the surgery. The purpose of the study is to determine whether the type of anesthesia used during breast cancer surgery has any impact on the way a patient's immune system functions for a brief period after surgery. To study the affect on the immune system, the patient's blood will be drawn at four different times for tumor cell analysis.

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.

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

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.

  • Participation TimeCoincides with standard treatment
  • Participating research sites Nearest research site: Contact sponsor; 1 site total

Breast Reconstruction and Quality of Life After Mastectomy

Patient Preferences for Breast Reconstruction After Mastectomy (NCT01488357)

Summary

Women who have a mastectomy must decide whether or not to have breast reconstruction. Some women want reconstruction and never receive it. And others who have reconstruction later say that they regret their decision. This could mean that women are not being given good information about the procedure, or that their personal preferences are not being fully considered. This study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life and body image. To be eligible, participants must be planning on having a mastectomy, with or without breast reconstruction, at the University of North Carolina in Chapel Hill.

Treating Breast Cancer in Pregnant Women

Multimodality Treatment of Primary Breast Cancer Occurring Concomitant With Pregnancy (NCT00510367)

Summary

Little is known about the impact of anti-cancer therapies on pregnant women or their developing fetus. The goal of this clinical research study is to learn the effects of multimodality (chemotherapy, surgery and radiation therapy) treatment of primary breast cancer when given during pregnancy. Researchers want to evaluate the outcome of labor and delivery as well as evaluate the long-term health outcomes of children exposed to chemotherapy while in their mother's womb.

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.

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.

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.

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.

Integrating Complementary and Standard Cancer Care

Breast Cancer Integrative Oncology: Prospective Matched Controlled Outcomes Study (NCT01366248)

Summary

Complementary and Alternative Medicine (CAM) is defined as medical and health care systems, practices, and products that are not thought of as standard care. Integrative Oncology (IO) is an approach to cancer care that combines conventional treatments with CAM therapies that have been found to be safe and effective in high-quality studies. The purpose of this study is to look at the use of CAM and IO in community settings and to investigate the effect that these therapies have on breast cancer patients' quality of life and risk of recurrence. To be eligible, participants must be receiving their care at a participating clinic in Washington state.

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.

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.

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

Screening

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.

Laboratory

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.

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.

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.

No Travel Required

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 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 
Lymphedema

Axillary Reverse Mapping During Surgery to Reduce Risk of Lymphedema

ARM: Axillary Reverse Mapping (NCT00572481)

Summary

Breast cancer surgery typically involves removing on or more of the axially lymph nodes--the lymph nodes under the arm, where the cancer may have spread. The procedure can increase a woman's risk of developing lymphedema, a painful swelling of the hand, wrist or arm. The location of the lymphatic drainage system may be a risk factor for lymphedema. This study is using axillary reverse mapping (ARM), a procedure that involves injecting blue dye into the lymph system, to identify where the lymph nodes drain and to reduce the risk of lymphedema after breast cancer surgery.
This is a Phase II trial