Breast - Female

ID:AAAC8882

Externally Peer Reviewed
Principal Investigator: Dr. Dawn Hershman

Adult: Phase I-II trial of vorinostat plus weekly paclitaxel (+/- trastuzumab) followed by doxorubicin-cyclophosphamide in patients with locally advanced breast cancer (HER-positive or ?triple-negativequot; or ER-positive, HER2-negative)

This is a Phase I-II Primary Investigator initiated, randomized study for about 54 women with histologically or cytologically confirmed adenocarcinoma of the breast; and no prior chemotherapy, irradiation, or definitive therapeutic surgery (eg, mastectomy or lumpectomy or axillary dissection) for this malignancy. Through the help of information gained form this 5-10 year long study, researchers hope to determine the recommended phase II dose of vorinostat in combination with weekly paclitaxel/trastuzumab, (2) to determine the pathological CR rate in patients with Her2/neu positive locally advanced breast cancer. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:NYSPI 4891

Institutional
Principal Investigator: Dr. Carlos Blanco

Adult: A pilot trial of interpersonal psychotherapy for the treatment of depression in patients with breast cancer.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAE3550

Industry
Principal Investigator: Dr. Kevin Kalinsky

Adult: An Open-Label Study of AMG 386 in Combination with Either Paclitaxel and Trastuzumab or Capecitabine and Lapatinib in Subjects with HER2-positive Locally Recurrent or Metastatic Breast Cancer

This is an open-label phase 1b trial evaluating the safety, tolerability, and Pharmacokinetics (PK which is the study of how a drug enters and leaves the blood and tissues over time) of the investigational drug AMG 386 in combination with either capecitabine/lapatinib or paclitaxel/trastuzumab. Subjects with HER2-positive locally recurrent or metastatic breast cancer will be enrolled in this 2-part study. Study part 1 is a dose de-escalation study to determine a tolerable dose of AMG 386 in combination with paclitaxel and trastuzumab (cohort A) or with capecitabine and lapatinib (cohort B). Study part 2 is cohort expansion of the tolerable dose determined in part 1. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAE7053

Industry
Principal Investigator: Dr. Dawn Hershman

Adult: A prospective, randomized, double-blind, stratified, multicenter, 2-arm trial of the continued efficacy and safety of Zometareg; (every 4 weeks vs. every 12 weeks) in patients with documented bone metastases from breast cancer

This is a prospective, double-blind, stratified, multicenter, two-arm clinical trial in subjects with documented bone metastases from breast cancer pretreated with either Zometa, Aredia, or a combination of both for at least 9 doses during the first 10 to 15 months of treatment, and are on Zometa at the time of study entry. Patients will be randomized on a 1:1 ratio to one year of continued treatment with Zometa every 4 weeks or Zometa every 12 weeks (with placebo infusion every 4 weeks for the intervening 8 weeks). The reason for this study is to find out if zoledronic acid (also called Zometa®) is still safe and helpful for subjects who have breast cancer that has spread to the bone and have been taking Zometa and/or Aredia for about a year. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:NYSPI 5996

Externally Peer Reviewed
Principal Investigator: Dr. Carlos Blanco

Adult: Interpersonal psychotherapy for depression in breast cancer

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAD8521

Externally Peer Reviewed
Principal Investigator: Dr. Heather Greenlee

Adult: Phase I randomized, placebo-controlled, cross-over, dose-finding pharmacokinetic study of CoQ10 during one cycle of doxorubicin treatment for breast cancer

This is a phase I randomized, placebo-controlled, cross-over pharmacokinetic and dose-finding study to assess the safety of CoQ10 during doxorubicin (Adriamycin) treatment for breast cancer. Doxorubicin is a breast cancer treatment that has been shown to prolong survival. However, approximately 3-20% of women who receive doxorubicin treatment experience some damage to their heart muscle. Coenzyme Q10 is a fat-soluble antioxidant dietary supplement that may protect against this heart damage during doxorubicin treatment. It is unknown whether doxorubicin concentrations will go up, down, or remain the same with Coenzyme Q10. This study will assess the effects of different dose levels of Coenzyme Q10 on doxorubicin metabolism. A maximum of eighteen patients will be accrued from Columbia University Medical Center and followed for about one month. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAD7133

Externally Peer Reviewed
Principal Investigator: Dr. Andreas Hielscher

Adult: Optical Tomographic Breast Imaging

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAE7054

Institutional
Principal Investigator: Dr. Dawn Hershman

Adult: Randomized sham controlled trial of weekly electro-acupuncture for the prevention of taxane induced myalgias and neuropathy

This is a two arm randomized pilot study. This study seeks to determine if 12 weeks of weekly electro-acupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of paclitaxel. The study will enroll a total of 50 patients, half of whom will be assigned to one of the two arms to receive electro-acupuncture or sham acupuncture. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female, Colon, Rectum

ID:AAAI1321

Externally Peer Reviewed
Principal Investigator: Dr. Heather Greenlee

Adult: FEASIBILITY STUDY OF A PHYSICAL ACTIVITY AND DIETARY CHANGE WEIGHT LOSS INTERVENTION IN BREAST AND COLORECTAL CANCER PARTICIPANTS, PHASE II

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAI9154

Institutional
Principal Investigator: Dr. Kevin Kalinsky

Adult: Predicting response with optical tomographic imaging for women with breast cancer enrolled in pre-surgical or ?window of opportunityquot;

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAJ0250

Institutional
Principal Investigator: Dr. Dawn Hershman

Adult: S0927: A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness in Women with Early Stage Breast Cancer, Phase III

The purpose of this study is to compare the effects, good and/or bad, of the nutritional supplement omega-3-fatty acid against placebo on the joint pain and stiffness that is associated with taking aromatase inhibitors. The primary hypothesis of the study is that omega-3-fatty acid will decrease joint pain and/or stiffness associated with the use of aromatase inhibitors (AI) in breast cancer patients compared to placebo at 12 weeks. Joint pain/stiffness will be assessed using ?worst pain and/or stiffness? according to the Brief Pain Inventory (BPI). Enrollees must currently be taking AIs and must exhibit joint pain/stiffness with a minimum BPI worst pain/stiffness score of 5; scores of 5 to 10 are considered to reflect moderate to severe pain. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAI8001

Externally Peer Reviewed
Principal Investigator: Dr. Katherine Crew

Adult: S0812: A Randomized Double-Blind Placebo-Controlled Biomarker Modulation Study of High Dose Vitamin D in Premenopausal Women at high-Risk for Breast Cancer, Phase IIB

The purpose of this study is to see if vitamin D affects breast tissue by reducing breast tissue thickness (the amount of glandular breast tissue compared to fat) on a mammogram (a special imaging exam of the breast that uses x-rays) and if it reduces the growth of breast cells. Also, we want to find out what effects on the breast and also side effects vitamin D has. Vitamin D is a natural vitamin supplement. Currently, tamoxifen is the only drug approved to reduce the risk of breast cancer in high-risk premenopausal women. However, tamoxifen does not prevent all breast cancers. Therefore, we are testing vitamin D to see if it affects the breast tissue and could be developed as a future option to prevent breast cancer. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAF3912

Externally Peer Reviewed
Principal Investigator: Dr. Kevin Kalinsky

Adult: Pre-surgical evaluation of MK-2206 in Patients with Operable Invasive Breast Cancer

This study hopes to assess for a decrease in phospho-Akt levels in tissue after a pre-surgical trial of weekly MK-2206 (2 doses) in patients with operable invasive breast cancer, and to evaluate the effects of MK-2206 on these patients.The purpose of this research study is to learn how a new anti-cancer drug, MK2206, affects breast cancer tumor cells. MK-2206 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in breast cancer.The PI3K/Akt signaling pathway is an important pathway in breast tumor biology. At the cellular level, the pathway has multiple functions, including aiding in breast cancer growth and spread. As a result, significant research has focused on the development of new drugs that target this pathway, with the hopes of impeding breast cancer growth. MK-2206 is an investigational drug that may keep cancer cells from growing and/or spreading by blocking a certain protein (Akt) in the cells. The purpose of this study is to determine the effects of MK-2206 on women with newly diagnosed breast cancer during the interval between breast biopsy and surgery. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAF3794

Externally Peer Reviewed
Principal Investigator: Dr. Dawn Hershman

Adult: RANDOMIZED BLINDED SHAM- AND WAITLIST-CONTROLLED TRIAL OF ACUPUNCTURE FOR JOINT SYMPTOMS RELATED TO AROMATASE INHIBITORS IN WOMEN WITH EARLY STAGE BREAST CANCER

This is a randomized, III multicenter trial, which will be accruing 200 women with early stage breast cancer from several sites. About 60 women will be accrued from Columbia University Medical Center. Over the course of about 24 weeks, these women will be evaluated to determine whether or not true acupuncture administered twice weekly for 6 weeks compared to sham acupuncture causes a significant reduction in joint pain/stiffness related to aromatase inhibitors (AIs) in women with early stage breast cancer as measured by the Brief Pain Inventory-Short Form (BPI-SF) worst pain, pain severity, and pain-related interference scores. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAI0480

Externally Peer Reviewed
Principal Investigator: Dr. Dawn Hershman

Adult: Predicting Response to Neoadjuvant Chemotherapy Using Optical Tomographic Imaging in Women with Breast Cancer

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAF3783

Institutional
Principal Investigator: Dr. Sheldon Feldman

Adult: ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer

The primary purpose of this study is to examine the effectiveness of creating an area where no cancer cells are found once the primary tumor has been removed using a method called Radiofrequency Ablation (RFA). Ablation is the term used to describe cell destruction. The RFA device generates heat that results in the destruction of any cell in the area around where the tumor is removed, an area called the cavity or tumor bed. The standard lumpectomy makes an incision in the skin approximately the size of the mass to remove the mass and a rim (safety zone) of normal tissue around it all in one piece. In this study, after the standard lumpectomy, RFA will be used to ablate (heat) this area of tissue around the lumpectomy cavity, which results in the destruction of any cell in the zone left exposed by the lumpectomy. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAF0193

Externally Peer Reviewed
Principal Investigator: Dr. Kevin Kalinsky

Adult: A Randomized Phase II Study of Fulvestrant vs. Fulvestrant in Combination with Bortezomib in Women with ER Positive Metastatic Breast Cancer

This randomized Phase II is being done in order to determine whether the combination of a drug called fulvestrant (which attaches to the estrogen receptor and blocks its activity) given in combination with a drug called bortezomib (that blocks the cancer cells ability to break down unwanted proteins) is more effective than fulvestrant alone. About 118 people total will take part in this study and about 10 of these people will receive treatment at Columbia University Medical Center. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAF3901

Cooperative Group
Principal Investigator: Dr. Daniela Gidea-Addeo

Adult: A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma

This is a Phase II research study of repeat breast preserving surgery and 3D-Conformaal partial breast re-irradiation for subject with a recurrence of breast cancer. When a second cancer is discovered in a breast previously treated with radiation to the whole breast following lumpectomy, the standard treatment is a mastectomy. Very few studies have been done to find out if breast conservation therapy (repeat lumpectomy and re-irradiation to part of the breast) can be applied as an alternative to mastectomy. The purpose of this study is to evaluate the side effects of partial breast re-irradiation given after a lumpectomy. The lumpectomy will remove the breast cancer and a limited amount of surrounding normal breast tissue. Following the surgery, the subject will receive three dimensional conformal radiation therapy (3D-CRT) to treat only the area in the breast where the lumpectomy was performed. 3D-CRT tries to lower the amount of radiation that normal tissues receive, while still delivering the desired amount of radiation to the cancer and to areas that the subject?s study doctor thinks may have cancer cells. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAI1832

Institutional
Principal Investigator: Dr. Katherine Crew

Adult: Breast Cancer Family_Based Intervention Trial: A Randomized Controlled Trial of a Clinical/Behavioral Intervention to Increase Uptake of Breast Cancer Prevention Strategies Among Female First Degree Relatives of Women With Breast Cancer

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAI3552

Cooperative Group
Principal Investigator: Dr. Daniela Gidea-Addeo

Adult: A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer

This is a phase 3 research study for subjects who have breast cancer and underwent a lumpectomy to remove the cancer and have been recommended by their doctor to have radiation therapy to the breast.Studies have shown that giving radiation therapy to the breast after lumpectomy helps keep cancer from coming back in the breast. However, this radiation therapy is commonly given to the entire breast on a Monday through Friday basis for 5 weeks. In addition, studies have shown that for many women giving a higher dose of radiation to the area of the lumpectomy, also known as a ?boost?, helps further lower the risk of cancer coming back in the breast. However, this adds another 1 to 1 ½ weeks of treatment so that the total time needed for radiation treatment commonly requires up to six to seven weeks for a women to complete.Recent studies have also shown that the chance of cancer returning in the breast can be the same with a higher daily dose of radiation given to the whole breast in a fewer number of treatments over only three weeks. This has the potential for shortening the number of days a woman is required to undergo radiation. These studies did not determine whether a boost may also be given at the same time at this more accelerated radiation schedule.The purpose of this study is to compare radiation therapy given with a higher daily dose over 3 weeks with a boost given each day of radiation therapy compared with standard whole breast radiation followed by a boost given on separate days which extends over 6 to 6 ½ weeks. It is not expected that there would be a difference in survival by changing the number of daily treatments and shortening the length of time needed for treatment. However, shortening treatment length could be more convenient and save time and money. It is not known, but it is hoped, that the higher daily dose of radiation to the breast has the same chance or better of preventing the breast cancer returning compared to standard daily doses of radiation.In this study, subjects will get either a standard daily dose of radiation therapy to the whole breast followed by additional radiation to only the area of the surgical cavity (boost) using the same standard daily dose of radiation OR a higher daily dose to the whole breast and to the boost on the same days but in a shorter overall number of daily treatments. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAI1793

Cooperative Group
Principal Investigator: Dr. Kevin Kalinsky

Adult: A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

This is a randomized phase III trial of adjuvant therapy comparing chemotherapy alone (six cycles of docetaxel plus cyclophosphamide or four cycles of doxorubicin plus cyclophosphamide followed by weekly paclitaxel) to chemotherapy plus trastuzumab in women with node-positive or high-risk node-negative HER2-low invasive breast cancer. The main purpose of this study is to learn if adding a targeted therapy, trastuzumab (Herceptin), to standard treatment with chemotherapy for early stage, HER2-low breast cancer, will prevent breast cancer from returning.Trastuzumab is called a targeted therapy because it targets the tumor cells by blocking the HER2 protein on the surface of the cancer cell to slow down or stop cancer growth. Trastuzumab is a standard treatment for HER2-positive breast cancer. In this study, trastuzumab is considered to be investigational because it has not been studied for use in treating HER2-low breast cancer. Studies that already have been done with trastuzumab focused on breast cancers that were strongly HER2-positive. However, in some of these studies, tumor samples were checked in a central laboratory to confirm the HER2 testing results. Some breast cancers that were thought to be HER2-positive were actually HER2-low. The researchers then looked at the results of treatment in subjects with HER2-low tumors. They found that trastuzumab seemed to have benefit in keeping the cancer from returning even when the HER2 levels were in the normal range. The B-47 study is being done to learn more about using trastuzumab to treat HER2-low breast cancer.A second purpose of this study is to learn if adding trastuzumab to treatment with chemotherapy will help women with HER2-low breast cancer live longer.In order to learn more about certain characteristics of cancer tumors, this study includes special research tests that will be done on samples of the tumor that were removed during surgery for breast cancer and on blood samples that will be collected during the study. Another goal of this study is to find out how the drugs used in this study affect menstrual cycles (monthly periods) and if these changes in menstrual cycles have any effect on breast cancer. The B-47 study will also explore the possibility that other medical conditions, medications subjects may be taking, or other factors such as alcohol intake, smoking, and weight may affect breast cancer. Subjects will be asked to complete questionnaires and allow blood samples to be taken to help answer these questions. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAF3743

Externally Peer Reviewed
Principal Investigator: Dr. Matthew Maurer

Adult: A Novel Combination Therapy for Triple Negative Breast Cancer: Erlotinib and Metformin

The purpose of this study is to identify the highest tolerable dose of metformin in combination with erlotinib while testing whether the combination can stop the growth of triple negative breast cancers. This study will enroll between 17 to 20 people with advanced triple negative breast cancer. While metformin is one of the most widely used drugs in the treatment of diabetes, research has suggested that it has anticancer properties. Diabetic patients taking metformin may develop less breast cancers than those not taking metformin and metformin has been shown to help prevent tumor formation in animal models. How metformin is working to do this is not completely understood. The idea for this specific clinical study came from work performed in Dr. Maurer's lab showing that the combination of metformin and erlotinib can inhibit triple negative cancer cells.Erlotinib (which is also known as Tarceva) is an oral medication which has been approved by the Food and Drug Administration (FDA) for use in subjects with lung or pancreatic cancer, but it has not been shown to be effective in the treatment of breast cancer when given alone. Erlotinib inhibits a specific protein in cells called the epidermal growth factor receptor (EGFR), which some tumor cells have in abundance and use to grow, divide and survive. This protein is expressed in a large number of triple negative breast cancers.Subjects enrolled will be offered treatment with erlotinib given daily at 150 mg which will remain the same throughout the study. A target dose of metformin will be assigned for each subject and metformin dose will be increased up to that dose over a period of one to two weeks. A schedule of drug dosing will be given to the subject. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female, Breast - Female

ID:AAAL2702

Industry
Principal Investigator: Dr. Kevin Kalinsky

Adult: A Randomized, Double-blind, Parallel-group, Multicenter, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEXTM) 500 mg with Anastrozole (ARIMIDEXTM) 1 mg as Hormonal Treatment for Postmenopausal Women with Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy (FALCON)

This is a randomized, double-blind, parallel-group, multicenter, phase III study to compare the efficacy and tolerability of Fulvestrant (FASLODEX TM) 500 mg with Anastrozole (ARIMIDEXTM) 1 mg as hormonal treatment for postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy.This research study is being done to find out more about the treatment of cancer of the breast or that has spread to areas of the body that are distant to it. Many breast cancers grow more quickly and spread more widely in the presence of hormones (in this case, estrogens) that are typically produced by the ovaries. Even after the menopause when the ovaries stop working, the small amounts of these hormones produced in other parts of the body encourage the growth of many breast cancers. Laboratory tests on pieces of cancer removed from the breast can determine whether or not estrogens have an effect on the breast cancer.Several drugs are available that block either the production of estrogens or reduce their effects on breast cancer. Two of these are being studied in this research. Fulvestrant (also known as FASLODEXTM) is a drug that reduces the effects of estrogens on breast cancers. Anastrozole (ARIMIDEXTM), in contrast, reduces the amounts of estrogens made in the body. Both drugs slow the growth of many breast cancers, and in some cases, reduce the sizes of the cancers. Previous research has suggested that two injections of fulvestrant every 28 days may be more effective than one tablet of anastrozole a day, but we cannot, at the moment, be sure that this is the case. This research study measures the size of breast cancer tumors every 12 weeks and will help to decide whether fulvestrant slows the growth of these tumors more than anastrozole. The research is being carried out in subjects who have not previously been treated with these or similar drugs because hormone-responsive breast cancers seem to be most sensitive to anti-estrogen treatments in this situation. In this study, dummy tablets or injections which contain no active ingredients (placebos) are being used so that the cancers can be measured without knowing which drug is being used in which subjects.Both fulvestrant and anastrozole are well established and widely used for the treatment of breast cancer. Both drugs have been approved in the United States by the Food and Drug Administration (FDA) for various stages in the treatment of breast cancer. The two drugs used in this research have not been directly compared in large numbers of patients who have not previously been treated with hormonal treatments before. Future patients would therefore benefit from the results of this new research. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAL2664

Institutional
Principal Investigator: Dr. Dawn Hershman

Adult: Topical Menthol for Chemotherapy Induced Peripheral Neuropathy (CIPN): A Randomized, Placebo Controlled Phase II Trial

We will conduct a two arm placebo controlled randomized phase II study design examining the effect of topical menthol on persistent neuropathic symptoms following chemotherapy among breast and colorectal cancer patients.The study population will be male or female patients with persistent neuropathic pain, completing either a taxane (paclitaxel, docetaxel or albumin-bound paclitaxel ? Abraxane) containing or an oxaliplatin-based neoadjuvant/adjuvant chemotherapy for the treatment of either breast or colorectal cancer respectively. Chemotherapy treatment is to be completed within two years prior to registration.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAK6752

Institutional
Principal Investigator: Dr. Katherine Crew

Adult: A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAI9158

Institutional
Principal Investigator: Dr. Kevin Kalinsky

Adult: A Phase II Study of the Beta-Blocker Propranolol Alone and With Chemotherapy in Patients Receiving Neoadjuvant Treatment for Newly Diagnosed Breast Cancer

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAJ8301

Externally Peer Reviewed
Principal Investigator: Dr. Dawn Hershman

Adult: S1105: RANDOMIZED TRIAL OF TEXT-MESSAGING INTERVENTION TO REDUCE EARLY DISCONTINUATION OF ADJUVANT AROMATASE INHIBITOR THERAPY IN WOMEN WITH EARLY STAGE BREAST CANCER

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAK0950

Cooperative Group
Principal Investigator: Dr. Kevin Kalinsky

Adult: A Phase III Clinical Trial Comparing the Combination of Docetaxel plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

The B-49 study is a multicenter, open-label, randomized Phase III, adjuvant therapy trial. This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.The researchers also want to learn about the side effects of the combinations of drugs used in this study. Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during breast cancer surgery.About 1843 women from different cancer treatment centers will take part in this study. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAK3212

Institutional
Principal Investigator: Dr. Dawn Hershman

Adult: YOUNG AND STRONG: An Education and Supportive Care Intervention Study for Young Women with Breast Cancer

Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAK5950

Industry
Principal Investigator: Dr. Matthew Maurer

Adult: AN OPEN-LABEL, PHASE II, SINGLE-ARM STUDY OF EVEROLIMUS IN COMBINATION WITH LETROZOLE IN THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR POSITIVE METASTATIC BREAST CANCER

This is an open-label, phase II, single-arm research study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer. Everolimus is an investigational drug which has not been approved for the treatment in postmenopausal women with estrogen receptor positive metastatic breast cancer. It has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation. Everolimus is approved in Europe and other global markets (trade name: Certican®) for cardiac and renal transplantation, and in the United States (trade name: Zortress®) for the prevention of organ rejection of kidney transplantation. Everolimus has also undergone extensive development in oncology as Afinitor®. Afinitor® was approved for advanced renal cell carcinoma (RCC) in 2009 in various countries, including the USA and Europe. In 2010, Afinitor® received USA approval for patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS). Everolimus is also available as Votubia® in the European Union for patients with SEGA associated with TS. Afinitor® is also indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery in the USA. In 2011, Afinitor® was approved for progressive PNET in patients with unresectable, locally advanced, or metastatic disease in various countries, including the USA and Europe. In 2012, Afinitor® was approved for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2- negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole in the USA.Letrozole and exemestane are considered to be treatments that are effective therapies currently available to patients with your type and stage of cancer. They demonstrated efficacy in the treatment of postmenopausal women with advanced breast cancer.The purpose of this study is to investigate new treatment options for postmenopausal women with estrogen receptor positive, HER 2 negative, locally advanced or metastatic breast cancer. The study will first evaluate the combination of everolimus and letrozole and then everolimus and exemestane. Enrolled subjects will be given everolimus and letrozole. After completing treatment with everolimus and letrozole, subjects will then be offered treatment with everolimus and exemestane. Subjects enrolled in this study will be provided with everolimus, letrozole and exemestane or dexamethasone (a prescription mouth rinse) as needed.The safety assessments in this study will be based on subjects ability to tolerate the combination treatment of everolimus and letrozole and of the combination of everolimus and exemestane. .This study will also evaluate the effectiveness of a prescription mouth rinse to reduce the severity and duration of oral stomatitis. Stomatitis is a common adverse event associated with everolimus. It manifests as redness, irritation, swelling in the mouth or mouth ulcers. Subjects diagnosed with stomatitis will have a 50% chance of being treated with either a dexamethasone prescription mouth rinse or the standard of care to treat stomatitis. Subjects will also be asked to complete a subject reported outcome questionnaire (PRO) (a daily symptom questionnaire) called the Oral Stomatitis Daily Questionnaire (OSDQ) every day that they are treated for stomatitis. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAK7452

Externally Peer Reviewed
Principal Investigator: Dr. Matthew Maurer

Adult: Phase II Trial of Akt Inhibitor MK2206 in Patients with Advanced Breast Cancer who Have Tumors with a PIK3CA Mutation and/or PTEN Loss

This is a Phase II research trial of Akt inhibitor (MK2206) for subjects who have breast cancer that is metastatic (has spread to other parts of the body), is locally advanced, or is recurrent (has returned) and cannot be removed by surgery. The purpose of this clinical research study is to learn if MK2206 can help to control advanced, metastatic, or recurrent breast cancer. The safety of this drug will also be studied.MK2206 is an investigational drug and is not approved by the Food and Drug Administration (FDA) or commercially available. It is currently being used for research purposes only. Please click here to view more information in ClinicalTrials.gov.

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.

Breast - Female

ID:AAAI1144

Institutional
Principal Investigator: Dr. Dawn Hershman

Adult: Evaluation of test to detect aromatase inhibitors in the urine - Part C

For more information and to inquire about eligibility for this study, please contact the Cancer Center office at 212-305-8615.