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Stage III Inflammatory Breast Cancer

Last updated: April 29, 2016


Chemotherapy

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 DM1 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

What's Involved    Contact information

Radiation & Chemotherapy Together or Sequentially for Early-Stage, ER- Breast Cancer

"Randomized Trial of Partial Breast Irradiation (PBI) and Sequential vs. Concurrent Chemotherapy in Women With ER Negative Early Stage Breast Cancer (PBI 3.0)" (NCT01928589)

Summary

Following surgery, patients with ER-negative breast cancer typically receive radiation followed by chemotherapy. Previous studies suggest that giving radiation therapy and chemotherapy at the same time is also a safe and effective way to treat early-stage ER-negative breast cancer. Partial-breast irradiation (PBI) is a type of radiation therapy given only to the area of the breast where the cancer was removed. This study will compare the safety and effectiveness of giving PBI and chemotherapy at the same time with giving PBI followed by chemotherapy in patients with early-stage ER-negative breast cancer.
This is a Phase I-II trial

What's Involved    Contact information

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

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

Summary

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

What's Involved    Contact information

A Vaccine & Chemotherapy Followed by Anakinra or Booster Shots for Triple Negative Tumors

Pilot Safety Trial of Anakinra Combined With Chemotherapy and Dendritic Cell Vaccine in Patients With Locally Advanced, Triple-Negative Breast Cancer (NCT02018458)

Summary

Immunotherapy–teaching the body's immune system to go after cancer cells—is a new area of cancer research. A dendritic cell vaccine is a patient-specific vaccine that is manufactured by taking a blood sample from the patient. After receiving the vaccine, patients typically receive a series of booster shots. Anakinra (kineret) stops inflammation by blocking IL-1 β, an immune protein found in high levels in breast cancer. It is currently used to treat rheumatoid arthritis and other autoimmune diseases. Studies suggest it may help bolster cancer vaccines. ACT (Adriamycin®, Cytoxan®, Taxol®) is a chemotherapy regimen commonly used to treat breast cancer. This study is comparing the effectiveness of using vaccine booster shots or Anakinra following treatment with ACT and the dendritic cell vaccine in patients with locally advanced triple negative breast cancer.
This is a Phase I-II trial

What's Involved    Contact information

Eribulin and AC Before Surgery for HER2-Negative Inflammatory Breast Cancer

A Phase 2 Study of Eribulin Followed by Doxorubicin and Cyclophosphamide as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer (NCT02623972)

Summary

Eribulin (Halaven®) is a chemotherapy drug used to treat advanced breast cancer. AC (Adriamycin® and Cytoxan®) is used to treat inflammatory breast cancer before surgery. Adding Halaven to the AC treatment may be more effective than using AC alone. This study is evaluating the safety and effectiveness of treating HER2-negative inflammatory breast cancer patients with Halaven and AC before they have surgery.
This is a Phase II trial

  • Participation TimeAt least 8 visits over 6 months plus surgery
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

What's Involved    Contact information

Abraxane® and Paraplatin® Before Surgery for Stage II & 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

What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information

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.

What's Involved    Contact information

Targeted Therapies Plus Chemo Before Surgery For ER+, HER2+ Breast Cancer

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy (Taxotere, Trastuzumab and Pertuzumab) in Patients With HER2-positive and ER-Positive Breast Cancer (NeoHTTP Study) (NCT02345772)

Summary

Giving therapy before surgery -- called neoadjuvant treatment -- allows doctors to study how well a tumor responds to a cancer regimen. If the therapy is successful, there are no cancer cells remaining at the time of surgery--and the patient is said to have had a "pathologic complete response." Some studies have suggested that women who have a pathologic complete response after neoadjuvant treatment have a better prognosis. Fulvestrant (Faslodex®) is a hormone therapy used to treat ER+ metastatic breast cancer in postmenopausal women who have tried other hormone therapies. Docetaxel (Taxotere®) is a chemotherapy drug commonly used to treat breast cancer. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2 targeted therapies. This study will look at the effectiveness of using Faslodex, Taxotere, Herceptin and Perjeta to obtain a pathologic complete response in women with ER+, HER2+ breast cancer.

What's Involved    Contact information

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

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

Summary

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

What's Involved    Contact information

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.

What's Involved    Contact information

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

What's Involved    Contact information
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.

What's Involved    Contact information
Radiation oncology

Proton vs. Photon Radiotherapy for DCIS or Stage I-III Breast Cancer

Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341)

Summary

Photon radiation therapy is the standard X-ray radiation therapy used to treat breast cancer. Proton radiation therapy is a type of radiation treatment that delivers radiation more directly to the cancer cells, making it less likely to damage nearby normal tissues. It is often used to treat brain tumors. This study is comparing the side effects and effectiveness of photon radiation to proton radiation when it is used to treat DCIS or stage I-III breast cancer. To be eligible, a patient must be between the ages of 21 and 65 and have had a lumpectomy or a mastectomy.

  • Participation TimeVisits 5 times a week over 2 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Intraoperative Radiation Registry at Bethesda North Hospital in Ohio

Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT) (NCT02364960)

Summary

Intraroperative radiotherapy (IORT) is delivered during surgery immediately after the tumor has been removed. This allows the radiation to target the tissue surrounding the tumor, where the risk of recurrence is highest. This registry will follow women who have IORT for up to 10 years, so that researchers can study its effectiveness and side effects. To be eligible to receive IORT and be part of the registry, a woman must be scheduled for breast conserving surgery and have a low risk of local recurrence.

What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information
Hormone therapy

Atezolizumab & Kadcyla or Atezolizuma, Herceptin & Perjeta in HER2-Positive Breast Cancer

A Phase Ib, Open-Label, Two-Arm Study Evaluating The Safety And Pharmacokinetics of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Trastuzumab Emtansine or With Trastuzumab And Pertuzumab in Patients With Her2 Positive Breast Cancer (NCT02605915)

Summary

Atezolizumab (MPDL3280A) is a new immunotherapy drug that blocks the programmed death 1 (PD-1) protein. Blocking the protein allows the immune system to kill cancer cells. Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are HER2-targeted therapies. Trastuzumab emtansine (Kadcyla®) combines the chemotherapy drug DM1 with Herceptin. This study is comparing the safety and effectiveness of atezolizumab, Herceptin and Perjeta to atezolizumab and Kadcyla in patients with HER2-positive metastatic breast cancer or with a HER2-positive primary tumor >2.0cm.

  • Participation TimeVisits every 3 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793
Targeted therapy

Kadcyla Before Surgery for HER2-Equivocal Stage I-III Breast Cancer

Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer (NCT02725541)

Summary

Breast tumors that are not clearly HER2-positive or HER2-negative are called HER2-equivocal. Trastuzumab emtansine (Kadcyla®) combines the chemotherapy drug DM1 with the HER2-targeted therapy Herceptin. It is used currently to treat patients with HER2-positive metastatic breast cancer. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study how the cancer responds to the treatment. This study is evaluating the safety and effectiveness of giving Kadcyla before surgery to women newly diagnosed with stage I-III HER2-equivocal breast cancer.
This is a Phase II trial

  • Participation TimeVisits every 3 weeks for 1.5 or 3 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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 trastuzumaub (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 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

What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information

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

What's Involved    Contact information

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

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

Summary

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

What's Involved    Contact information

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 (Kadcyla®)—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

What's Involved    Contact information
Vaccines and Immunotherapy

A Breast Cancer Vaccine & Chemo Before Surgery in Stage I-III Breast Cancer

A Combined Phase I/II Feasibility-and-Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG Combined With Neoadjuvant Chemotherapy (NCT02229084)

Summary

Cancer researchers are studying many different types of cancer vaccines. P10s-PADRE is a new vaccine that is designed to get the immune response to fight breast cancer. Montande™ ISA 51 VG is an oil-based substance that help enhance the immune response triggered by P10s-PADRE vaccine. Giving a therapy before surgery—called neoadjuvant treatment—allows researchers to see if the treatment can shrink the tumor. This study is looking at the effect that the P10s-PADRE vaccine (used with Montande) has when it is given along with neoadjuvant chemotherapy to patients with estrogen receptor positive (ER+) stage I, II or III breast cancer.
This is a Phase I-II trial

What's Involved    Contact information

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

What's Involved    Contact information

Mammaglobin-A DNA Vaccine + Hormone Therapy Before Surgery for ER+, HER2- Breast Cancer

A Phase 1B Randomized Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy (NCT02204098)

Summary

Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Laboratory studies suggest a mammaglobin-A DNA vaccine may trigger the body's immune system to destroy cancer cells. Hormone therapies are used to treat hormone-sensitive tumors. These medications include anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), goserelin (Zoladex®) and tamoxifen. Giving treatment before surgery--called neoadjuvant therapy--allows researchers to study how the cancer responds to the treatment. This study is comparing the immune response seen in women with stage II or III ER-positive, HER2-negative breast cancer who receive a mammaglobin-A DNA vaccine along with hormone therapy or hormone therapy alone before surgery. The type of hormone therapy used will be chosen by the woman's oncologist. To be eligible for the study, a woman must have a breast tumor that expresses mammaglobin-A. In addition, participants must have a tumor Ki67 value of ≤ 10% after 14 days of neoadjuvant hormone therapy in order to be randomized to receive the Mammaglobin-A DNA vaccine.
This is a Phase I trial

What's Involved    Contact information
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

What's Involved    Contact information
Diagnosing Breast Cancer

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.

What's Involved    Contact information

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.

What's Involved    Contact information
Support/Education

Psychiatry Support for Patients with Severe Mental Illness Diagnosed with Cancer

Proactive Psychiatry Consultation for Patients With Cancer and Severe Mental Illness (NCT02594696)

Summary

Cancer is a leading cause of death in individuals with severe mental illness (SMI). Researchers think adding a psychiatrist and social worker to the oncology team of individuals with SMI will improve their care. This study is investigating the feasibility and effectiveness of incorporating a psychiatry consultation and care management support for individuals with SMI diagnosed with breast (and other cancer) to cancer care. To be eligible, participants must be able to receive care at and be within 8 weeks of their initial oncology consultation at the Massachusetts General Hospital Cancer Center.

  • Participation TimeCoincides with standard therapy
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

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Lifestyle Changes During Radiation Therapy to Improve Outcomes

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

Summary

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

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

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

Summary

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

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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.

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

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

Summary

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

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Self-Care Toolkit for Managing Side Effects After Surgery

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

Summary

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

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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

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Surveys/Interviews

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

Treatment Decisions and Breast Cancer: Psychosocial Outcomes (NCT02263014)

Summary

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

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

The Health of Women (HOW) Study (NCT02334085)

Summary

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

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Breast Cancer in Women Diagnosed Before Age 40

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

Summary

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

  • Participation TimeBlood sample and questionnaire by mail
  • No Visits Required for this TrialNo travel required 
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A Study of the Inherited KRAS-Variant Mutation and Breast Cancer Risk

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

Summary

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

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Cancer Support Community Online Survey: The Cancer Experience Registry

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

Summary

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

  • Participation TimeOnline questionnaire
  • No Visits Required for this TrialNo travel required 
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Using a Brain Fitness Program to Study the Effect of Chemotherapy on the Brain

An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer (NCT02515487)

Summary

Many breast cancer patients who are treated with chemotherapy develop a decrease in mental "sharpness" (including memory and though processes). This is often referred to as "chemobrain." In this study, breast cancer patients will answer questions on a computer-based Brain Fitness Program before and after their chemotherapy treatment. This will allow the researchers to identify the types of cognitive difficulties women who receive chemotherapy experience. Participants will have the option to participate in the second phase of the study, which involves the use of a computer-based tool to further evaluate cognitive function.

  • Participation Time40 sessions over 3 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Effect of Chemo & Hormone Therapy on Hair, Skin & Nails in Early-Stage Breast Cancer

A Prospective, Longitudinal Study of Chemotherapy-Induced Hair Changes and Alopecia, Skin Aging and Nail Changes in Women With Non-Metastatic Breast Cancer (NCT02530177)

Summary

This study is looking at the effect that chemotherapy and hormone therapy have on the skin, hair and nails of women with early-stage breast cancer. The researchers want to see if there are certain clinical factors or genetic markers that can help predict which women are most likely to develop skin, hair or nail problems. To be eligible, participants must be about to start treatment with chemotherapy or hormone therapy for stage 0-III breast cancer.

  • Participation TimeCoincides with standard treatment
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Perspectives on Exercise in Women Diagnosed with Breast Cancer

Study on Breast Cancer Patient Perspectives of Exercise (NCT02559362)

Summary

This study is surveying breast cancer patients to determine how likely it is that women who have been diagnosed with breast cancer would consider delaying surgery to participate in an exercise program. If enough women say they might delay surgery, the researcher may conduct an exercise study in the future.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

A Study of Inflammatory Markers, Chemotherapy and Chemobrain

Inflammation-Induced CNS Glutamate During Breast Cancer Treatment (NCT02421978)

Summary

Chemotherapy often causes cognitive symptoms (chemobrain) that can continue for months to years after treatment has ended. Inflammation caused by chemotherapy may contribute to these cognitive problems. In this study, researchers will measure the level of inflammatory markers in the blood and the brain of breast cancer patients receiving chemotherapy, breast cancer patients not receiving chemotherapy, and healthy volunteers to better understand the link between chemobrain and chemotherapy.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

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

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

Summary

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

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

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

Summary

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

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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.

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Registry For Studying Side Effects of Hormone Therapy

Johns Hopkins Breast Cancer Program Hormone Therapy Longitudinal Database (NCT01937052)

Summary

Hormone therapies are used to prevent and treat breast cancer. This project will collect information, blood, and saliva samples from women on hormone therapy to treat breast cancer or to reduce breast cancer risk. Participants will complete questionnaires about new breast cancer diagnoses, side effects they experience, and use of hormone therapy. If participants develop breast cancer, they will be asked to donate a tumor sample. The overall aim of the study is to learn what side effects hormone therapies cause, why some women are more prone to developing these side effects than others, whether there are biomarkers that predict who is most likely to develop side effects, how best to treat side effects, and whether side effects influence a patient's willingness to keep taking her hormone therapy.

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Screening

A Blood Test for Breast Cancer Detection

Free Fatty Acid Metabolite Biomarkers for Cancer (NCT01692951)

Summary

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

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Activities

Yoga for Breast Cancer Patients Undergoing Chemotherapy

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

Summary

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

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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.

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Acupuncture to Reduce Side Effects in Breast Cancer Patients Receiving Taxol

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

Summary

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

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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.

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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

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

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

Summary

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

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Managing Side Effects

Zocor to Reduce Adriamycin-Related Heart Problems

Detection and Prevention of Anthracycline-Related Cardiac Toxicity With Concurrent Simvastatin (NCT02096588)

Summary

Different types of chemotherapy drugs have different side effects. Anthracyclines, like doxorubicin (Adriamycin®), are a type of chemotherapy drug that may weaken the heart muscle. This heart damage can happen during or right after chemotherapy or it may occur many years later. The results of previous studies suggest that drugs used to lower cholesterol, called statins, may prevent anthracycline-related heart damage. Simvastatin (Zocor®) is an oral statin routinely used to lower cholesterol. This study is investigating whether women who take Zocor when receiving Adriamycin are less likely to experience heart damage than women who receive Adriamycin alone. To be eligible, a woman must be planning to receive the chemotherapy regimen AC (Adriamycin and Cyclophosphamide) before or after surgery.
This is a Phase II trial

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Curcumin for Reducing Fatigue Related to Chemotherapy and Radiation Therapy

Randomized Phase II Study of Curcumin Versus Placebo for Inhibition of NF-kB DNA Binding in Peripheral Blood Mononuclear Cells of Chemotherapy-Treated Breast Cancer Patients Undergoing Radiotherapy (NCT01740323)

Summary

Fatigue is one of the most common side effect of radiation therapy. Previous studies have found that the NF-kB pathway appears to play a role in chemotherapy- and radiation-related inflammation and fatigue. Curcumin—an active component in turmeric—is a known inhibitor of the NF-kB protein. Researchers think decreasing the activity of NK-kB may reduce fatigue in women with breast cancer being treated with radiation. Meriva is a curcumin formula that is well absorbed by the body. In this study, researchers will compare the effectiveness of Meriva to a placebo for controlling cancer-related fatigue in women receiving whole-breast radiation. To be eligible, a woman must be scheduled to receive whole-breast radiation.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Melatonin to Reduce Fatigue Caused by Radiation Therapy

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

Summary

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

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Measuring Taxane-Induced Neuropathy in Breast Cancer Patients Receiving Taxol

Early Detection of Taxane-Induced Neuropathy in Women With Breast Cancer (NCT02549534)

Summary

Peripheral neuropathy--numbness, tingling, or burning pain in the hands or feet--is a common side effect of paclitaxel (Taxol®). An axon reflex is a response brought on by peripheral nerve stimulation. Axon reflexes can be measured after heating the skin of the big toe. Researchers believe there is a correlation between the size of the axon reflex and the severity of self-reported chemotherapy-induced peripheral neuropathy. This study is investigating whether the axon reflex test correlates with self-reporting of nerve damage in breast cancer patients receiving Taxol®.

  • Participation Time3 visits over 7 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Metformin for Reduction of Paclitaxel-Related Neuropathy

Metformin for Reduction of Paclitaxel Treatment-Related Neuropathy in Patients With Breast Cancer: A Randomized Pilot Study (NCT02360059)

Summary

Paclitaxel (Taxol®) is a chemotherapy drug routinely used to treat breast cancer. Peripheral neuropathy--numbness, tingling, or burning pain in the hands or feet--is a common side effect of Taxol. Metformin is an oral drug commonly used to control insulin levels in people with diabetes. Laboratory studies suggest metformin may also help control paclitaxel-related neuropathy in women being treated for breast cancer. To be eligible, participants must be planning to receive Paclitaxel (Taxol®) at Lyndon B. Johnson General Hospital in the Harris Health System in Texas and not be taking metformin for other health reasons.

  • Participation TimeWeekly visits for 3.5 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Acupuncture For Treating Post-mastectomy Pain, Nausea and Anxiety

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

Summary

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

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Acupuncture for Treating Chemotherapy-Induced Peripheral Neuropathy

Acupuncture for CIPN in Breast Cancer Patients (NCT02615678)

Summary

Peripheral neuropathy--pain, tingling, burning, or a numbness sensation in the hands and feet—is a common side effect of chemotherapy. Acupuncture is a traditional Chinese medicine technique that involves inserting sterile, hair-thin needles into specific points on the skin to stimulate the nervous system. This study will evaluate the effect that acupuncture treatments have on breast cancer patients who have developed peripheral neuropathy. To be eligible, patients must currently be receiving chemotherapy and have been experiencing symptoms for at least 1 month.

  • Participation TimeVisits 16 times over 10 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Acupuncture to Reduce Pain Associated With Use of Tissue Expanders for Reconstruction

Effectiveness of Acupuncture in Post-Mastectomy Patients With Tissue Expanders (NCT02639611)

Summary

Breast reconstruction with implants is typically done in two stages. The first stage, done at the time of surgery, involves the insertion of a tissue expander, which is slowly filled with saline. The second stage is a second surgery that replaces the expander with a permanent implant. During expansion, patients often experience significant pain and discomfort. This study is investigating whether acupuncture can help reduce shoulder tightness, chest tightness, and general pain in women undergoing breast reconstruction with tissue expanders.

  • Participation Time2 visits a week for 6 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

Ice Therapy (Cryotherapy) for Reducing Taxol-Induced Pain

Pilot Clinical Trial Evaluating the Utility of Topical Cryotherapy to Decrease Chemotherapy-Induced Peripheral Neuropathy (CIPN) and Paclitaxel-Induced Acute Pain Syndrome (P-APS): A Randomized Controlled Trial (NCT02640053)

Summary

Ice therapy, or cryotherapy, uses an extremely cold liquid to freeze and destroy abnormal tissue. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. Paclitaxel (Taxol®) is a chemotherapy drug that is routinely used to treat breast cancer. Its side effects include peripheral neuropathy and similar types of aches and pains. Cryotherapy may be effective in reducing peripheral neuropathy and other pain caused by chemotherapy. This study is investigating whether individuals who receive cryotherapy along with Taxol experience less pain than those who receive Taxol alone. To be eligible, participants must be planning to be treated with Taxol and not have prior exposure to neurotoxic chemotherapy.

  • Participation TimeVisits weekly for 3 months
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

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Atrovastatin to Reduce Anthracycline-Related Heart Damage in Early Stage Breast Cancer

Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT) (NCT01988571)

Summary

Different types of chemotherapy drugs can have different types of side effects. Anthracycline chemotherapy drugs like doxorubicin (Adriamycin®) and epirubicin (Ellence®) are known to cause heart-related side effects. Previous studies have suggested that statins—drugs used to reduce cholesterol—may prevent anthracycline-related heart damage. Atrovastatin is an oral statin that is commonly used to lower blood cholesterol levels. This study will investigate whether women being treated for early-stage breast cancer who receive Adriamcyin or Ellence along with atrovastatin experience fewer heart-related side effects than women who receive Adriamycin or Ellence and a placebo. To be eligible, a woman must be scheduled to receive Adriamycin or Ellence after surgery.
This is a Phase II trial

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Vitamin D When Starting on an Aromatase Inhibitor to Reduce Bone/Joint Pain

A Randomized, Controlled Trial of High Dose vs. Standard Dose Vitamin D for Aromatase-Inhibitor Induced Arthralgia in Breast Cancer Survivors (NCT01988090)

Summary

Aromatase inhibitors—anastrazole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®)—are routinely used to treat hormone-sensitive breast cancer in postmenopausal women. Joint/muscle pain is one of the most common side effects caused by these drugs. Vitamin D deficiency can result in a wide array of musculoskeletal issues. Some studies have suggested that vitamin D may help prevent or reduce aromatase inhibitor-related joint/muscle pain. This study is looking at the safety and effectiveness of two different doses of vitamin D for reducing joint/muscle pain in postmenopausal women with stage I to III breast cancer who are starting treatment with an aromatase inhibitor.
This is a Phase II trial

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Naltrexone for Treating Fatigue That Develops During Radiation Therapy

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

Summary

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

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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.

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

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

Summary

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

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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.

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Other

Measuring Circulating Tumor DNA to Predict Treatment Response

Tumor Specific Plasma DNA in Breast Cancer (NCT01617915)

Summary

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

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

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

Summary

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

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Effect of Chemotherapy on Fat Metabolism

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

Summary

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

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University of New Mexico Cancer Center Breast Cancer Registry and Tissue Bank

Expanded Breast Cancer Registry and Tissue Repository (NCT00322894)

Summary

The New Mexico Tumor Registry (NMTR) collects information about breast cancer incidence and survival in the state of New Mexico. The type of treatment patients receive is not routinely collected by the registry. The Expanded Breast Cancer Registry and Tissue Repository (EBCR) is a new registry that will collect this information. Patients will also have the opportunity to donate extra breast tissue samples to the tissue bank (repository). Researchers will use the tissue bank to conduct laboratory-based genetic studies on breast cancer risk, prognosis and survival. To be eligible, participants must have been diagnosed within one year and be receiving breast cancer treatment at the University of New Mexico Comprehensive Cancer Center.

  • Participation Time1 visit
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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.

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Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial

An Initiative for Molecular Profiling in Advanced Cancer Therapy (IMPACT) Trial. A Molecular Profile-Based Study in Patients With Advanced Cancer Treated in the Investigational Cancer Therapeutics Program (NCT00851032)

Summary

Molecular profiling allows researchers to identify a tumor's specific mutations and biomarkers. Researchers are trying to see if there is an association between the tumor's molecular profile, how the tumor responds to drugs in phase I trials, and which side effects the patient experiences. To be eligible, participants must be receiving care at the Investigational Cancer Therapeutics department at MD Anderson Cancer Center in Texas.

  • Participation TimeNumber of visits unavailable
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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

Summary

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

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

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

Summary

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

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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

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

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

Summary

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

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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.

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Johns Hopkins Breast Cancer Program Tissue Bank

Johns Hopkins Breast Cancer Program Longitudinal Repository (NCT01937039)

Summary

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

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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.

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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

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Complementary and Alternative Medicine

Comparing Hypnosis and Muscle Relaxation for Improving Self-Image After a Cancer Diagnosis

A Mind-body Intervention to Improve Body and/or Self Image: a Phase II Randomized Trial (NCT02531997)

Summary

Hypnotic relaxation therapy uses hypnosis, a technique that helps individuals enter a state of calm, alert awareness, to help people make personal changes. Progressive muscle relaxation therapy is a relaxation techniques that uses tensing and relaxing of the muscles to help people become more aware of physical sensations. This study will investigate whether hypnotic relaxation therapy is more effective than progressive muscle relaxation therapy for improving body/self-image in women who have been diagnosed with breast (or gynecologic) cancer. To be eligible, a woman must report having had a change in body/self image since her cancer diagnosis, wish to improve her body/self-image, and be able to attend sessions at the University of Michigan Cancer Center.

  • Participation Time3 visits over 6 weeks
  • Participating research sites
    Research sites:
    Call BCT: (415) 476-3793
What's Involved    Contact information: Call BCT at (415) 476-3793

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

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Preventing Recurrence

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

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

Summary

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

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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.

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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

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