Breast Cancer

Clinical Trials

2010-146

Title: I-SPY 2 TRIAL: Investigation of Serial studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2.

Description: This study is for women with newly diagnosed breast cancer who will receive chemotherapy prior to surgery (neoadjuvant therapy). There are 2 phases of this study: the screening phase and the treatment phase. The screening phase is to determine whether women are eligible to participate in the treatment phase. The purpose of the treatment phase is to try to determine how women with breast cancer will respond to standard chemotherapy and standard chemotherapy with investigational drugs on the basis of particular markers in the tumor tissue and blood. In addition to treatment all subjects on this study will be required to undergo 2 core biopsies of their tumor and have 3 breast MRIs for research purposes and have blood drawn for research studies. The standard chemotherapy in this trial is 12 weeks of paclitaxel followed by 4 cycles of doxorubicin and cyclophosphamide given once every 2 or 3 weeks. Subjects with HER2+ breast cancer will also receive trastuzumab during the 12 weeks of paclitaxel. Subjects will be randomized (like the flip of a coin) to either standard treatment or standard treatment plus an investigational (not yet approved by the FDA) drug. Which investigational drug one will receive will be based on when a subject enters the study and which drugs are being tested at that time.

For more information on this study from ClinicalTrials.gov, click here!

2011-156

Title: SCUSF 0806: Phase II placebo-controlled trial of lisinopril and Coreg CR to reduce cardiotoxicity in patients with breast cancer receiving (neo)adjuvant chemotherapy with trastuzumab (Herceptin).

Description: This study is for patients who have been diagnosed with breast cancer and are scheduled to start trastuzumab (Herceptin), which can cause problems with heart function. The purpose of this study is to compare the effects, good and/or bad, of an ACE inhibitor (lisinopril) or a beta-blocker (Coreg CR {carvedilol phosphate extended release]) on heart function during treatment with trastuzumab (Herceptin), a drug given as treatment for your breast cancer. Lisinopril and Coreg CR are used to treat high blood pressure, heart failure, and in heart attack patients. Study doctors want to find out which treatment (lisinopril or Coreg CR) is better at protecting heart function during treatment of breast cancer. The effect of the medicines will be compared to a placebo, which contains no active frug. All subjects will only get one of the study medicines (lisinopril, Coreg CR or placebo). The study medicine is given as a pill once a day.

For more information on this study from ClinicalTrials.gov, click here!

2013-0278

Title: 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.

Description: To evaluate the cardiac safety of HER2 targeted therapy (non-lapatinib) in patients with HER2 positive breast cancer and reduced left ventricular ejection fraction (LVEF) when given concomitantly with cardiac treatment.

For more information on this study from ClinicalTrials.gov, click here!

2013-0364

Title: SWOG S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating The Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer.

Description: The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for breast cancer patients. In this study, you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormonetreatment and everolimus is experimental in patients with breast cancer.

For more information on this study from ClinicalTrials.gov, click here!

2013-0381

Title: Pilot Study to Evaluate Conditionally Reprogrammed Cells from Unresected Estrogen Receptor Positive Breast Tumors Treated with Endocrine Therapy Alone.

Description: You are being asked to participate in this study because the biopsies of your breast tumor may help investigators develop new tools for selecting the right therapy for each breast cancer patient. Breast cancer is an overgrowth of abnormal cells in the breast that can eventually spread to the other organs, if left untreated. Similarly to each person being different from another, also each breast cancer is different from one patient to another. Yet, currently most breast cancers are treated with the same combination of medications. Sometimes a medication that works for one patient, does not work for another due to the fact that her breast cancer is different. The breast cancer cells collected from the biopsies will be grown on a dish and drugs will be tested on the cells, instead of testing the drugs on patients.

2013-0962

Title: A Pilot Study to Evaluate Conditionally Reprogrammed Cells from Triple Negative Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy.

Description: Breast cancer research led to improved treatments. However, not all breast cancers can be currently cured. Cancers that may seem very similar to each other can behave very differently. An example of such cancer is triple negative breast cancer, a subtype that is only sensitive to chemotherapy. Some triple negative breast cancers are cured with chemotherapy, while others are not sensitive to the drugs that we currently use. However, we do not know how to distinguish them from each other and women with this type of cancer receive the same type of treatments, which may or not be effective. Therefore, we need to understand how we can predict which tumors will do well with the available drugs and develop better drugs for those that do not.

This study aims to test a new promising technique that allows growing cancer cells from a patient in the laboratory. If the technique works well in breast cancer, these cells could then be studied and new treatments could be tested. The knowledge obtained this way could have a significant impact in the development of breast cancer treatments, particularly for tumors like triple negative breast cancer that currently have limited treatment options.

2013-1173

Title: ECOG E2108: A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer.

Description: The standard treatment for metastatic breast cancer is the use of chemotherapy, anti-hormone pills, or other medication. When the cancer is no longer only in the breast and has spread to other areas of the body, surgery and/or radiation for the tumor in the breast cannot control the other areas of the cancer and are only used if the breast tumor is causing skin breakdown or pain, which happens only in some patients. For most people, the tumor in the breast is controlled with medicine and does not cause problems. We do not know if local treatment (surgery and/or radiation) used early in the course of treatment of the breast cancer will help patients with metastatic breast cancer live longer or not. The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor. In this study, you will get either surgery plus radiation for your breast, or continue with the best medical treatment advised by your doctor. If you receive the standard treatment but the medicine is no longer controlling the tumor in the breast, and your doctor feels you need surgery or radiation, you may receive this when you need it.

For more information on this study from ClinicalTrials.gov, click here!

2013-1226

Title: KAITLIN: A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients with Operable HER2-Positive breast cancer.

Description: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combination with Perjeta (pertuzumab) versus Herceptin (trastuzumab) in combination with Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenously (iv) every three weeks or Herceptin 6 mg/kg iv every three weeks in combination with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment is up to 1 year.

For more information on this study from ClinicalTrials.gov, click here!

2013-1362

Title: OSU 13117: A single arm, phase II study of single agent trametinib followed by trametinib in combination with GSK2141795 in patients with advanced triple negative breast cancer.

Description: This study is for patients who have a partial or complete response to treatment with trametinib in advanced triple negative breast cancer (TNBC) patients. This is an open label, two-stage phase II study of single agent trametinib followed by trametinib in combination with GSK2141795 in patients with advanced TNBC.

Your body has proteins that are involved in a cancer's ability to grow and survive. Trametinib and GSK2141795 may prevent these proteins from causing cancer growth.

There are 2 parts to this study. In Part 1 of this study, you will receive trametinib. At a time in which trametinib is not working you will begin on Part 2 of the study. In Part 2 of this study, you will receive trametinib and GSK2141795.

For more information on this study from ClinicalTrials.gov, click here!

2013-0587

Title: NSABP B-51/RTOG 1304: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy.

Description: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

For more information on this study from ClinicalTrials.gov, click here!

2014-0367

Title: A011202: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy.

Description: This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy alone in treating patients with node-positive breast cancer previously treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection.

For more information on this study from ClinicalTrials.gov, click here!

2014-0369

Title: A011106: ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study.

Description: This study has several objectives. One purpose is to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer. It is also considered a standard of care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women with early stage breast cancer before or after surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast cancer that has spread to other parts of the body. Therefore, fulvestrant alone, and the combination of anastrozole and fulvestrant is the investigational treatment in this study. 

For more information on this study from ClinicalTrials.gov, click here!

2014-0505

Title: NSABP B-52: A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP)With or Without Estrogen Deprivation or Testing the addition of hormonal therapy to usual chemotherapy in advanced breast cancer.

Description: This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen deprivation in treating patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-positive, operable or locally advanced breast cancer. Drugs used in chemotherapy, such as docetaxel, carboplatin, trastuzumab, and pertuzumab, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using goserelin acetate and aromatase inhibition therapy may fight breast cancer by blocking the use of estrogen by the tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy and radiation therapy with or without hormone therapy may be an effective treatment for hormone receptor-positive, HER2-positive, operable or locally advanced breast cancer.

For more information on this study from ClinicalTrials.gov, click here!

2014-0527

Title: Incyte INCB 18424-268 A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination with Capecitabine in Subjects with Advanced or Metastatic HER2-Negative Breast Cancer

Description:

About 148 women with advanced or metastatic HER2-negative breast cancer will be participating at approximately 100 study centers. All patients who participate in the study will receive the chemotherapy medication, capecitabine. Each patient will also be randomized to receive either ruxolitinib or placebo, to be taken in combination with capecitabine. “Randomized” means that you will be randomly (by chance – like flipping a coin) assigned to receive either ruxolitinib or placebo in combination with capecitabine. In this study, you will have a 50% chance of being randomized to receive ruxolitinib and a 50% chance of being randomized to receive placebo. If you choose to participate, neither you nor your study doctor and will not know what treatment group to which you are assigned.

You will receive the study treatment in 21 day (3 week) cycles. Ruxolitinib or placebo pills will be taken twice daily for the duration of each cycle. Capecitabine will be taken twice daily for the first two weeks of each cycle (14 days), followed by one week off (7 day break)."

For more information on this study from ClinicalTrials.gov, click here!

2014-0641

Title: WO29217 Berenice - A Multinational, Phase II Study to Evaluate Pertuzumab in Combination with Trastuzumab and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients with HER2-Positive, Locally Advanced, Inflammatory

Description: The purpose of this study is to find out what effects, good or bad, pertuzumab has on you and your disease. Specifically, one of the purposes is to look at cardiac safety (safety relating to the heart). The study will investigate treatment with pertuzumab in combination with commonly used treatments for patients with newly diagnosed breast cancer that has not spread to other parts of the body. 

For more information on this study from ClinicalTrials.gov, click here!

2014-0882

Title: ECOG E2112: A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer

Description:

The purpose of this study is to find out what effects, both good and bad, an experimental drug called entinostat has on you and your cancer, when given together with the standard hormonal drug treatment, exemestane. Exemestane is an aromatase inhibitor which is used in breast cancer patients to inhibit the growth of the breast cancer. In this study, you will take exemestane, and either entinostat or an inactive substance (placebo). Entinostat is investigational and has not been approved by the Food and Drug Administration (FDA) for use in this cancer. If you are a male, you will also receive Goserelin, a leutenizing hormone releasing hormone (LHRH) agonist that is used to suppress the production of testosterone and estrogen.

For more information on this study from ClinicalTrials.gov, click here!

2014-0911

Title: NSABP B-55/BIG 6-13: A Randomised, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Description:

The purpose of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for your type of cancer. In this study, you will get either olaparib or placebo, a pill that looks like the study drug but contains no medication. The use of olaparib could reduce the risk of your cancer coming back but it could also cause side effects. To be better than placebo, the olaparib should decrease the chance of cancer coming back as compared to the placebo. More than 2000 patients suffering from a variety of cancers have already taken olaparib at different doses, either on its own or with another chemotherapy drug. Olaparib is experimental and not approved by the Food and Drug Administration (FDA) for use in any type of cancer. As of October 2013 about 248 patients with advanced breast cancer have been treated with olaparib. 

For more information on this study from ClinicalTrials.gov, click here!

2014-1179

Title: OlympiAD: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and safety of Olaparib Monotherapy versus Physician’s Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients with germline BRCA1/2 Mutations (D0819C00003)

Description: This study is for patients who have been diagnosed with metastatic breast cancer associated with BRCA1 or BRCA2 mutation. This study is being carried out to see if a new treatment using a drug called olaparib is effective in treating metastatic breast cancer and how it compares with the doctor’s choice chemotherapy: capecitabine, vinorelbine or eribulin.

For more information on this study from ClinicalTrials.gov, click here!

2014-0025

Title: A Randomized Phase III Trial of Eribulin Compared to Standard Weekly Paclitaxel as First- or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Description:
The purpose of this study is:

  • To determine if eribulin mesylate (Halaven®) will work better than paclitaxel (Taxol®) for patients with breast cancer who have developed another tumor in the breast area that cannot be removed surgically or who have had the breast cancer spread to another part of the body.
  • To compare all the effects of eribulin mesylate versus paclitaxel on you and the underlying breast cancer.

For more information on this study from ClinicalTrials.gov, click here!

2015-0110

Title: TBCRC 031:A Randomized Phase II trial of Neoadjuvant Cisplatin vs Doxorubicin/Cyclophosphamide (“AC”) in Women with Newly Diagnosed Breast Cancer and Germline BRCA Mutations

The Inform: BRCA1/2 Study: Investigation Of Neoadjuvant Chemotherapy For Mutation Carriers: BRCA 1/2

Description: The study is for people who have an inherited mutation in the BRCA1 and/or BRCA2 gene and have recently been diagnosed with breast cancer. This research study is a way of gaining new knowledge about the most effective type of chemotherapy to treat breast cancers that develop in individuals with BRCA mutations. This research study is evaluating whether cisplatin, a chemotherapy agent not typically used to treat newly diagnosed breast cancer, is superior to doxorubicin and cyclophosphamide (“AC”) a standard breast cancer regimen