Home   /  Find a Trial  /  See All TrialsClick to print page Print
 
Match To Trials
Our Matching Service can help you find trials that are right for you.
 
Subscribe to our Newsletter

Stay Informed

Enter your email in the box below to receive our monthly e-newsletter.

We will never sell or rent your information. Your details are protected by our privacy policy.
 

browse by Tumor Type

Sort by zipcode:  

Share

Twitter
Facebook
Stage III Inflammatory Breast Cancer

Last updated: April 17, 2014


Chemotherapy

Valproic Acid With FEC100 Before Surgery for Locally Advanced Breast Cancer

A Phase II Study of Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Locally Advanced or Primary Metastatic Breast Cancer (NCT01010854)

Summary

The chemotherapy regimen FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) is one option for treating locally advanced or primary metastatic breast cancer. Valproic Acid is approved by the US Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine headaches. The results of a Phase I study of Valproic Acid and FEC 100 suggested that this combination may be better than FEC 100 alone. Furthermore, adding Valporic Acid to FEC 100 did not appear to cause more side effects. The goal of this study is to see whether adding the drug Valproic Acid (VPA) to FEC 100 increases its effectiveness.
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

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

Abraxane® and Paraplatin® for Stage III Triple Negative Tumors

Phase II Trial of Neoadjuvant Chemotherapy With Carboplatin and NAB-Paclitaxel in Patients With Locally Advanced and Inflammatory Triple Negative Breast Cancer (NCT01525966)

Summary

Chemotherapy drugs work by either killing cancer cells or by stopping them from dividing. Giving chemotherapy before surgery (called neoadjuvant therapy) may make the tumor smaller and reduce the amount of tissue that needs to be removed. Researchers can also study a drug's effectiveness by assessing how much the tumor shrinks in response to the treatment. Abraxane® (nab-paclitaxel) and Paraplatin® (carboplatin) are chemotherapy drugs that are approved for the treatment of advanced breast cancers. The goal of this study is to determine how well these two chemotherapy drugs work when they are given together before surgery to treat women with locally advanced or inflammatory triple negative (ER-/PR-/HER2-) 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.

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

Reducing Mastectomy-Related Pain

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

Summary

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

Surgery: Reconstruction

Meso BioMatrix Device for Breast Reconstruction

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

Summary

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

Radiation oncology

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.

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.

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 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

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

Targeted therapy

Kadcyla, Tykerb & Abraxane vs. Herceptin, Tykerb & Taxol Before Surgery for HER2+ Tumors

Randomized Open Label Phase II Trial Of Neoadjuvant Trastuzumab Emtansine (Te) In Combination With Lapatinib (L) Follow by Abraxane (A) Compared With Trastuzumab Plus Lapatinib Follow by Paclitaxel In Her 2 Neu Over-Expressed Breast Cancer Patients (TEAL Trial) (NCT02073487)

Summary

Researchers are trying to identify the most effective drug combination for treating HER2+ breast cancer. T-DM1 (Kadcyla®) combines the chemotherapy drug DMI with trastuzumab (Herceptin®), a drug used to treat HER2-positive tumors. This allows the chemotherapy drug to be delivered directly to the cancer cells. Lapatinib (Tykerb®) is a targeted therapy used to treat HER2+ breast cancer. Nab-paclitaxel (Abraxane®) is a chemotherapy drug used to treat advanced breast cancer. Paclitaxel (Taxol®) is a chemotherapy drug used to treat breast cancer. Giving chemotherapy before surgery allows researchers to study the effect that a treatment has on the breast tumor. This study is comparing the efficacy of Kadcyla, Tykerb and Abraxane to Herceptin, Tykerb and Taxol when it is given before surgery to patients with HER2+ breast cancer.
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

Panitumumab and Chemotherapy for Inflammatory Breast Cancer

Phase II Study of Panitumumab, Nab-paclitaxel, and Carboplatin for Patients With Primary Inflammatory Breast Cancer (IBC) Without HER2 Overexpression (NCT01036087)

Summary

Inflammatory breast cancer (IBC) is an aggressive type of advanced breast cancer. It is typically treated with chemotherapy prior to surgery. Panitumumab (Vectibix®) is a targeted therapy that works by preventing or slowing the growth of tumor cells by blocking proteins, called epidermal growth factor receptors, that are on the surface of cancer cells. Panitumumab is currently approved for the treatment of certain types of colorectal cancer, and researchers think it might also be effective for IBC. The goal of this trial is to study the safety and effectiveness of panitumumab when it is given with the chemotherapy drugs nab-paclitaxel (Abraxane®), carboplatin (Paraplatin®), fluorouracil (Adrucil®), epirubicin (Ellence®), and cyclophosphamide (Cytoxan®) before surgery to treat HER2-negative IBC.
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

Taxol, Herceptin + Perjeta Before Surgery for HER2+ IBC

Phase II Trial of Paclitaxel Combined With Trastuzumab and Pertuzumab as Pre-Operative Therapy for Inflammatory Breast Cancer (NCT01796197)

Summary

Researchers are studying new drugs and new treatment combinations for HER2+ Inflammatory Breast Cancer. Pertuzumab (Perjeta®) is used to treat HER2+ advanced breast cancer. It is a HER2-targeted therapy, like Herceptin, but it attaches to a different part of the HER2 receptor. Studies suggest it may also be effective when used before surgery to treat HER2+ inflammatory breast cancer. Currently Paclitaxel (Taxol®) and trastuzumab (Herceptin®) are given before surgery to treat HER2+ inflammatory breast cancer. This study is investigating the safety and effectiveness of giving Perjeta along with Taxol and Herceptin before surgery to treat HER2+ inflammatory breast cancer.
This is a Phase II trial

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

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

Summary

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

Digoxin in Newly Diagnosed Operable Breast Cancer

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

Summary

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

Perjeta, Herceptin and Chemo Before Surgery for HER2-Positive Breast Cancer

Single Arm, Neoadjuvant, Phase II Trial of Pertuzumab and Trastuzumab Administered Concomitantly With Weekly Paclitaxel and FEC for Clinical Stage I-II HER2-Positive Breast Cancer (NCT01855828)

Summary

Giving therapy before surgery (called neoadjuvant treatment) allows researchers to study the effect that a drug combination has on cancer cells. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies used to treat HER2+ tumors. T-FEC is a chemotherapy regimen used to treat breast cancer. "T" refers to paclitaxel (Taxol®), which is given first and then followed by FEC (5-fluorouracil, epirubicin and cyclophosphamide). Herceptin is often given with T-FEC. This study is investigating the effectiveness of adding Perjeta to Herceptin and T-FEC by giving it before surgery to women with stage I - III HER2+ breast cancer.
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

Tykerb® and Herceptin® for HER2+ Locally Advanced Disease

TBCRC 023: A Randomized Multicenter Phase II Neoadjuvant Trial of Lapatinib Plus Trastuzumab, With or Without Endocrine Therapy for 12 Weeks vs. 24 Weeks in Patients With HER2 Overexpressing Breast Cancer (NCT00999804)

Summary

There are currently two FDA-approved medications that work by targeting the HER2 protein, trastuzumab (Herceptin®) and lapatinib (Tykerb®). Studies suggest that it may be more effective to use the two drugs in combination to treat HER2+ tumors, rather than using just one of these drugs. The goal of this trial is to compare the effectiveness a 12-week and a 24-week treatment of Herceptin and Tykerb. To be eligible, participants must have locally advanced breast cancer. This is defined as a tumor greater than 3cm, or greater than 2cm if there is also tumor present in the lymph nodes.
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

Safety of HER2-Targeted Therapies in Patients with Mildly Decreased Heart Function

SAFE-HEaRt: A Pilot Study Assessing the Cardiac SAFEty of HER2 Targeted Therapy in Patients With HER2 Positive Breast Cancer and Reduced Left Ventricular Function (NCT01904903)

Summary

The HER2 targeted therapies—trastuzumab (Herceptin), pertuzumab (Perjeta) and ado-trastuzumab emtansine (Kadycla)—may cause heart problems in some patients. These drugs are currently approved only for patients with normal heart functioning. It may be possible for HER2+ patients with mildly decreased heart function to also safely use a HER2-targeted therapy. This study is looking at the safety of giving a HER2–targeted therapy to patients with mildly decreased heart function when these patients are evaluated regularly by a cardiologist and take heart medication. To be eligible, participants must have HER2–positive breast cancer and mildly decreased heart function.
This is a Phase II trial

Vorinostat Plus Chemotherapy and Herceptin® Before Surgery

Phase I-II Trial of Vorinostat Plus Weekly Paclitaxel and Trastuzumab Followed by Doxorubicin-Cyclophosphamide in Patients With Locally Advanced Breast Cancer (NCT00574587)

Summary

The standard treatment for early-stage HER2-positive breast cancer is chemotherapy and trastuzumab (Herceptin®). This regimen is sometimes given before surgery to reduce the size of the tumor, which may reduce the amount of healthy breast tissue that must be removed. Researchers are interested in learning whether adding other drugs to this combination will make it more effective. Vorinostat is a new type of oral cancer treatment called a histone deacetylase (HDAC) inhibitor. It works by activating both tumor suppressor genes and other genes leading to cancer cell death. The purpose of this trial is to determine the optimal dose of vorinostat that should be used with standard chemotherapy and Herceptin and whether adding vorinostat makes the regimen more effective.
This is a Phase I-II trial

Neratinib and Chemotherapy Before Surgery for HER2+ Disease

A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Therapy Regimens With Weekly Paclitaxel and Neratinib or Trastuzumab Followed by Doxorubicin and Cyclophosphamide With Postoperative Trastuzumab in Women With HER2+ Disease (NCT01008150)

Summary

Trastuzumab (Herceptin®) is a targeted therapy that is used to treat HER2+ breast cancer by blocking the HER2 receptor. Given in combination with standard chemotherapy, Herceptin® has been approved for both early stage and metastatic HER2+ cancer. Because some individuals will have their cancer recur after having been treated with Herceptin, researchers are trying to develop new therapies for HER2+ tumors. Neratinib is a new targeted therapy that inhibits both the HER2 receptor and proteins called EGFR kinases, which also help fuel cancer growth. The goal of this trial is to compare the effectiveness of neratinib and standard chemotherapy with Herceptin® and standard chemotherapy when it is given before surgery to shrink tumor size in individuals with stage III breast cancer. To be eligible at MD Anderson Cancer Center, participants must have inflammatory breast cancer.
This is a Phase II trial

Vaccines and Immunotherapy

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

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

Summary

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

Other treatment

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.

A New Approach to Studying How ER+ Tumors Respond to Treatment

Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status (NCT01916122)

Summary

Breast cancer tumors are tested to determine if they are estrogen receptor (ER) positive or negative. Those that are ER+ can be treated with an anti-estrogen therapy. A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells. A tracer called 16α-18F-fluoroestradiol (FES) looks for and attaches to estrogen receptors. Researchers think that it may be possible to use FES to monitor the effect that a cancer treatment is having on the breast tumor. This study will be exploring the use of FES with a PET/CT scan in women who have ER+ breast cancer and have not yet received hormone therapy.
This is a Phase O trial

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.

MRI in Women Who are Healthy, High Risk or Have Breast Cancer

Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants (NCT00474604)

Summary

Magnetic Resonance Imaging (MRI) is a sensitive method for detecting breast cancer that has been useful in evaluating women who are at high risk for breast cancer. In addition to standard MRI, three new methods are currently being studied: Magnetic Resonance Spectroscopy (MRS) provides information about the chemical make-up of the tumor tissue, Dynamic Contrast-Enhanced MRI (DCE-MRI) uses faster imaging and a contrast material to provide information about the tumor's blood vessels, and Diffusion-weighted MRI (DW-MRI) creates images that provide information about the tumor tissue. This study will compare how well these three different MRI methods find and characterize breast tumors, compared to standard MRI. Women who have been recently diagnosed or suspected to have breast cancer, as well as healthy volunteers, are eligible for this study.

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

Cognitive-Behavioral Therapy to Decrease Worry & Insomnia in Women with Advanced Disease

Worry, Uncertainty and Insomnia: A Cognitive-behavioral Intervention for Cancer Survivors (NCT01929720)

Summary

Many breast cancer survivors experience short- and long-term side effects of treatment—including trouble sleeping, worry and anxiety—that may decrease their quality of life. Counseling can help reduce anxiety and trouble sleeping and improve quality of life. Cognitive behavior therapy (CBT) is a type of counseling that can help patients understand and gain control over the thoughts and feelings that influence behaviors. CBT is commonly used to treat phobias, depression, and anxiety. This trial is exploring whether CBT can help reduce worry, anxiety, and trouble sleeping in women and men with stage III or stage IV breast cancer. This study is also enrolling patients with other types of cancers.

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.

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.

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

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.

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

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.

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.

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.

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.

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.

Preventing Heart Damage During Herceptin® Treatment

Lisinopril or Carvedilol Phosphate in Reducing Side Effects in Women With HER2-Positive Breast Cancer Receiving Trastuzumab (NCT01009918)

Summary

Trastuzumab (Herceptin®) is routinely used to treat HER2-positive breast cancer. However, Herceptin can cause heart damage and decrease heart function, especially when it is used in combination with certain chemotherapy drugs. Women who experience heart problems often stop taking Herceptin. They also typically start taking a beta blocker or an ACE inhibitor, two drugs that are commonly used to treat heart failure and that can reverse Herceptin-related heart damage.The goal of this trial is to test the effectiveness of taking lisinopril (a beta-blocker) or carvedilol (an ACE inhibitor) while on Herceptin to reduce the risk of heart damage. To be eligible, participants must be scheduled to receive Herceptin, with or without chemotherapy.
This is a Phase II trial

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.

Epidemiology

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.

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.

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.

Finding Biomarkers to Predict Which Tumors Will Respond to Tamoxifen

Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients (NCT01027416)

Summary

Tamoxifen is the standard of care for premenopausal women with hormone-positive breast cancer. Researchers are trying to identify biological markers (biomarkers) that can help them identify which women will benefit from tamoxifen. The p53 gene makes the p53 protein. Previous studies have shown that tumors that contain an abnormal p53 protein may not respond to tamoxifen. This study will investigate how tamoxifen affects p53 and other biomarkers by studying blood and tumor samples taken from women who are given tamoxifen before surgery. To be eligible for this study, a woman must be premenopausal, have hormone-positive breast cancer, and have a tumor that tests positive for the abnormal p53 protein.

Inflammatory Breast Cancer Registry

Inflammatory Breast Cancer (IBC) Registry (NCT00477100)

Summary

Inflammatory breast cancer is a rare, aggressive type of breast cancer in which the cancer cells block the lymph vessels in the skin, causing the breast to appear red and swollen. Researchers have not yet identified any genes or other risk factors that they could use to design better treatments for inflammatory breast cancer. The goal of this study is to collect blood and tissue samples and clinical data from patients with untreated newly diagnosed inflammatory breast cancer. The samples and data will be stored in a research tissue bank and used to help researchers learn more about inflammatory breast cancer.

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.

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.

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

Evaluating How Locally Advanced Tumors Respond to Chemotherapy

Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer (NCT01837563)

Summary

Receiving chemotherapy before surgery, referred to as neoadjuvant therapy, allows doctors to see if a tumor is responding to a specific chemotherapy regimen. This study is comparing four new imaging methods to determine which provides the best information about how the tumor is responding. Every patient in this study will have these four imaging tests: MRI Elasticity Imaging (MRE), Electrical Impedance Spectroscopy (EIS), Microwave Imaging and Spectroscopy (MIS), and Near Infrared Spectroscopy (NIR). Patients may also be given a contrast-enhanced MRI, and/or additional mammography to help researchers compare the experimental methods. These additional examinations are routine procedures and will be used when clinically indicated. To be eligible, a patient must have a locally advanced tumor and be receiving chemotherapy prior to surgery.

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.

Identifying Women at Risk of Developing Heart Problems From Herceptin & Adriamycin

Predicting Cardiac Effects of Breast Cancer Therapy (NCT00875238)

Summary

Heart damage is a potential side effect of some cancer therapies. Doxorubicin (Adriamycin®) is a standard breast cancer chemotherapy treatment. It is one of the drugs that is effective but can also cause heart damage. Trastuzumab (Herceptin®) is a targeted therapy routinely used to treat HER2-positive breast cancer. Heart muscle damage and heart failure are two potentially serious side effects associated with Herceptin. In this study, researchers will study blood samples taken from women receiving Adriamycin and Herceptin to try to identify biological markers (biomarkers) that may predict which breast cancer patients are at increased risk of developing heart damage. To be eligible, participants must be planning to undergo treatment with anthracycline-based chemotherapy.

Studying Which Tumors Respond Best to Taxol and Herceptin

NSABP Biospecimen Discovery Project (NCT01850628)

Summary

By studying how breast tumors respond to treatment, researchers hope to determine new ways to predict which breast cancer treatments will be most effective for which women. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study how chemotherapy or targeted therapy effects cancer cells. This study is specifically looking for biological markers (biomarkers) in the tumor or the blood that can predict how tumors will respond to the chemotherapy drug paclitaxel (Taxol) and the targeted therapy trastuzumab (Herceptin.) To be eligible, participants must be newly diagnosed with stage I-III, HER2-positive breast cancer and scheduled to receive Taxol and Herceptin before surgery.

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