Adult Clinical Trials

Breast Cancer

If you need additional information about any of the trials listed or would like to inquire about other open trials, please contact the Breast Oncology Clinical Trials Office at 919.660.1278.

19 trials identified.

An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients
Phase: N/A
Sponsor: PI initiated
Principal Investigator: Nimmi Ramanujam
Contact: Marlee Junker
Phone: 919.660.8446
Purpose: Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.
Reference Number: 00007857
View this trial at ClinicalTrials.gov

A Phase II Study of Neratinib Alone and in Combination with Fulvestrant in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Kimberly Blackwell
Contact: Breast Oncology Clinical Trials Office
Phone: 919.660.1278
Purpose: This phase II study will test cancer to see if it has a HER2 mutation and, if so, see how HER2 mutated cancer responds to treatment with neratinib.
Reference Number: 00045798
View this trial at ClinicalTrials.gov

Alliance A011202: A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Jeffrey Crawford
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer 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.
Reference Number: 00051624
View this trial at ClinicalTrials.gov

Alliance A011104 / ACRIN 6694: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Jeffrey Crawford
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.
Reference Number: 00051626
View this trial at ClinicalTrials.gov

A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE) in Patients with Metastatic, GPNMB Over-Expressing, Triple-Negative Breast Cancer (The METRIC Study)
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Kimberly Blackwell
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.
Reference Number: 00051804
View this trial at ClinicalTrials.gov

A Phase 3 Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
Phase: Phase III
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: P. Kelly Marcom
Contact: Breast Oncology Clinical Trials Office
Phone: 919.660.1278
Purpose: The study seeks to evaluate the efficacy and tolerability of veliparib/placebo in combination with carboplatin and paclitaxel in HER2-negative metastatic or locally advanced, unresectable, BRCA-associated breast cancer.
Reference Number: 00054924
View this trial at ClinicalTrials.gov

A RANDOMIZED PHASE II STUDY OF PREOPERATIVE CISPLATIN VERSUS PACLITAXEL IN PATIENTS WITH TRIPLE NEGATIVE BREAST CANCER: EVALUATING THE HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) BIOMARKER
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: P. Kelly Marcom
Contact: Breast Oncology Clinical Trials Office
Phone: 919.660.1278
Purpose: This research study is evaluating how well triple negative breast cancer responds to preoperative treatment with Cisplatin or Paclitaxel chemotherapy, and if use of a research test Homologous Recombination Deficiency (HRD) assay can predict response to preoperative treatment.
Reference Number: 00055567
View this trial at ClinicalTrials.gov

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
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: Jeffrey Crawford
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
Reference Number: 00060455
View this trial at ClinicalTrials.gov

Phase I Dose Escalation Trial of Intrathecal Pertuzumab and Trastuzumab in Patients with New Untreated Asymptomatic or Low Symptomatic Brain Metastasis in HER2 Positive Breast Cancer
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Kimberly Blackwell
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: The purpose of this research study is to determine how well pertuzumab and trastuzumab works in treating breast cancer that has spread to the brain. Pertuzumab and trastuzumab are treatments that stop breast cancer cells from growing abnormally by inhibiting (or blocking) members of a family of proteins that include Human Epidermal Growth Factor Receptor 2 (HER2). Pertuzumab and trastuzumab have been found to be very effective for HER2-positive breast cancer and are FDA approved for treatment of metastatic breast cancer outside of the brain when given through the vein. This suggests that pertuzumab and trastuzumab may help shrink or stabilize HER2-positive breast cancer that has spread to the brain in this research study. In this research study, the investigators are looking to see whether pertuzumab and trastuzumab will work to decrease the size of or stabilize breast cancer that has spread to the brain.
Reference Number: 00061309
View this trial at ClinicalTrials.gov

NSABP B-55/BIG 6-13: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center 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
Phase: Phase III
Sponsor: Cooperative Group Initiated
Principal Investigator: P. Kelly Marcom
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: Olaparib 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
Reference Number: 00061408
View this trial at ClinicalTrials.gov

Randomized Phase II trial of Neoadjuvant Cisplatin vs Doxorubicin/Cyclophosphamide (AC) in Women with Newly Diagnosed Breast Cancer and Germline BRCA Mutations DFCI 12-258
Phase: Phase II
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: P. Kelly Marcom
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, which is cisplatin in this trial, to learn how well it works in treating a specific cancer. Investigational means that cisplatin is still being studied for use in this setting and that research doctors are trying to find out more about it-in this case, how effective cisplatin is for treating breast cancer in BRCA mutation carriers. It also means that the FDA has not yet approved cisplatin for your type of cancer. Cisplatin has been approved by the FDA for treatment of other cancers. The purpose of this study is to evaluate cisplatin, a chemotherapy drug that has been shown to be active in the treatment of women with breast cancer and a BRCA mutation. In this study, we are comparing cisplatin to the standard chemotherapy, doxorubicin and cyclophosphamide (AC) that you might receive if you did not participate in this study.
Reference Number: 00061627
View this trial at ClinicalTrials.gov

CSF Pharmacokinetics of Systemic Therapies in Patients with Advanced Cancer and Brain Metastasis
Phase: N/A
Sponsor: Internal Investigator Initiated Non-therapeutic/Non-interventional
Principal Investigator: Kimberly Blackwell
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Reference Number: 00062142

Dose Optimization of Rosuvastatin in Early Stage and Metastatic Estrogen Receptor Positive Breast Cancer Patients on Endocrine Therapy
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Kimberly Blackwell
Contact: BREAST ONCOLOGY RESEARCH CLINICAL TRIALS TEAM
Phone: 919.660.1278
Purpose: Patients will be treated in a dose escalation scheme to investigate a role for the addition of a statin in the treatment of estrogen receptor positive breast cancer. Patients will take oral rosuvastatin daily. The maximum number of patients evaluable for a DLT is 12. Dosing will be as follows: Cohort 1 - rosuvastatin 20mg, Cohort 2 - rosuvastatin 40mg. The patients will have a total of 4 blood draws and 4 breast biopsies. The breast biopsies will be collected to evaluate cholesterol metabolites and tumor microenvironment characteristics including gene expression profiling and metabolomics. Sampling will occur at study entry, week 4, week 8, and at the time of surgery in early stage patients or at week 16 for metastatic patients. Patients will begin endocrine therapy following the acquisition of week 4 samples (blood and tissue biopsy).
Reference Number: 00062343
View this trial at ClinicalTrials.gov

LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition among Breast Cancer Survivors Age 65 and Older
Phase: N/A
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Gretchen Kimmick
Contact: Breast Oncology Clinical Trials Office
Phone: 919.660.1278
Purpose: To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.
Reference Number: 00063722
View this trial at ClinicalTrials.gov

The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed with Intraductal Papilloma without Atypia or Flat Epithelial Atypia by Core Needle Biopsy
Phase: N/A
Sponsor: External Investigator-Sponsored (External Med Ctr)
Principal Investigator: Shelley Hwang
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: This research study is studying a surgical intervention to rule out the presence of cancer in participants that have been diagnosed with flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA) by core needle biopsy.
Reference Number: 00066589
View this trial at ClinicalTrials.gov

Phase 2 Randomized, Double-Blinded, Controlled Study of ONT-380 vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
Phase: Phase II
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Kimberly Blackwell
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: The purpose of this study is to assess the effect of tucatinib vs. placebo in combination with capecitabine and trastuzumab on progression-free survival (PFS) per RECIST 1.1 based on independent central review.
Reference Number: 00067720
View this trial at ClinicalTrials.gov

A Phase 1/2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of VT-464 in Patients with Advanced Breast Cancer.
Phase: Phase I
Sponsor: Commercial / Industry (for-profit group) initiated
Principal Investigator: Kimberly Blackwell
Contact: Breast Oncology Clinical Research Office
Phone: 919.660.1278
Purpose: The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of VT-464, a lyase-selective inhibitor of CYP17, in patients with advanced breast cancer.
Reference Number: 00068128
View this trial at ClinicalTrials.gov

Alliance A011401: Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer
Phase: N/A
Sponsor: Cooperative Group Initiated
Principal Investigator: Jeffrey Crawford
Contact: Breast Oncology Clinical Research Office
Phone: 919.660.1278
Purpose: This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
Reference Number: 00074506
View this trial at ClinicalTrials.gov

Pilot Study of Mirvetuximab Soravtansine (IMGN853) in Folate Receptor Alpha (FRa)-expressing, Triple Negative Breast Cancer (TNBC) with Residual Disease post Standard Neoadjuvant Chemotherapy
Phase: Phase I
Sponsor: Internal Investigator Initiated Therapeutic &/or Interventional
Principal Investigator: Kimberly Blackwell
Contact: BREAST ONCOLOGY CLINICAL RESEARCH TEAM
Phone: 919.660.1278
Purpose: The main purpose of this study is to determine how 2 doses mirvetuximab soravtansine affects the amount and activity of folate receptor alpha proteins in tumor cells of patients who have completed standard neoadjuvant treatment and are scheduled to have their tumors surgically removed.
Reference Number: 00074621
View this trial at ClinicalTrials.gov