Clinical Trials- Breast

 DISEASE SITE

TITLE

 PHASE

 CONTACT

 LOCATION

 DCIS

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy (CTSU/NSABP B-43)

 III

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

--------------------------

Natasha Wilson, nwilson@mvcc.cc

 402-991-8070 x203

---------------------------------

Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com



---------------------------------

JoAnn Wilde 402-717-4714, joann.wilde@alegent.org


Nebraska Methodist Hospital
Omaha; Missouri Valley Cancer Consortium, Omaha, NE;  Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE; Catholic Health Initiatives











NEO/ADJUVANT





Breast

 Phase II Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response Following Neoadjuvant Chemotherapy (Sara Cannon BRE 186)

 II

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

Nebraska Methodist Hospital,
Omaha NE

Breast

A Phase II Randomized, Double-blind, Study of Ipatasertib (GDC-0068), An AKT inhibitor, In combination with  Paclitaxel as neoadjuvant treatment for patients with early stage triple negative breast cancer

II

 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha

Breast

 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, ER2-Negative Breast Cancer (CTSU/NSABP B-49)

 III

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

--------------

Natasha Wilson, nwilson@mvcc.cc

 402-991-8070 x203

---------------------------------

Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com 

Nebraska Methodist Hospital,
Omaha NE;  Missouri Valley Cancer Consortium, Omaha, NE;  Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE

Breast

 A Randomized Phase II Study of Eribulin/Cyclophosphamide or
Docetaxel/Cyclophosphamide As Neoadjuvant Therapy in Locally Advanced Her2-Negative Breast Cancer (Sara Cannon BRE 197)

II 

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

Nebraska Methodist Hospital,
Omaha NE

Breast

 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 (CTSU S1207)

 III

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

Nebraska Methodist Hospital,
Omaha NE

Breast

 A Phase III Trial of Accelerated Whole Breast Irradiation with Hypo fractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer (RTOG 1005)

 III

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

--------------

Deborah Meyer, RN, BGS

 (402) 559-6941

dmeyerk@unmc.edu

------------------------------

Nebraska Methodist Hospital,
Omaha NE; Nebraska Medical Center, Omaha, NE

Breast

 A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less (CTSU S1007)

 III

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

--------------

Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com 

 Nebraska Methodist Hospital,
Omaha NE;

Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE

Breast

 A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycle 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 (CTSU/NSABP B-47)

 III

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

--------------

Natasha Wilson, nwilson@mvcc.cc

 402-991-8070 x203

---------------------------------

Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com

-----------------------------------

JoAnn Wilde 402-717-4714, joann.wilde@alegent.org


Nebraska Methodist Hospital,
Omaha NE; Missouri Valley Cancer Consortium, Omaha, NE;  Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE;

Catholic Health Initiatives

 Breast

 A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less (S1007)

 III

 Natasha Wilson, nwilson@mvcc.cc

 402-991-8070 x203

------------

Deborah Meyer, RN, BGS

 (402) 559-6941

dmeyerk@unmc.edu  or  Kim Shields

 Missouri Valley Cancer Consortium, Omaha, NE; Nebraska Medical Center, Omaha, NE.

 Breast

A Phase II Study of Neoadjuvant Chemotherapy With and Without Trastuzumab in Patients with Breast Cancer

 II

  Deborah Meyer, RN, BGS

 (402) 559-6941

dmeyerk@unmc.edu  or Mary Mailliard

 Nebraska Medical Center, Omaha, NE

 Breast

 A Randomized Placebo-controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in women with Early Stage Breast Cancer. (SWOG-S1202)

 

  Michaela Sherbeck - michaelasherbeck@catholichealth.net

 Good Samaritan Cancer Center, Kearney, NE


A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer (CALGB-A211201)

 

 Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com 

 Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE

 Breast

Duloxetine Hydrochloride to Treat Muscle, Bone, and Joint Pain in Pts W/Early-Stage Breast Cancer Receiving Hormone Therapy (S1202)

 

 Kimberly Kaberle

210-6148808 x 1022

kkaberle@swog.org

 Good Samaritan Cancer Center

 Breast

 A Breast Cancer Information Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer (BCCR)

 

 Elizabeth Fleissner RN BSN

402-559-8197

eafleissner@unmc.edu

 Good Samaritan Cancer Center


CTSU: 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



Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250


Nebraska Methodist Hospital,
Omaha


A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy

(NSABP B-43)  NCT00769379


JoAnn Wilde 402-717-4714, joann.wilde@alegent.org

Catholic Health Initiatives


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 (NSABP B 51; RTOG 1304 ) NCT01872975


JoAnn Wilde 402-717-4714, joann.wilde@alegent.org

Catholic Health Initiatives


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.  (SWOG 1207)

NCT01674140


JoAnn Wilde 402-717-4714, joann.wilde@alegent.org


Catholic Health Initiatives


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  (Alliance

011202)  NCT01901094


JoAnn Wilde 402-717-4714, joann.wilde@alegent.org


Catholic Health Initiatives




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








Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

****PENDING 9/23

Nebraska Methodist Hospital,
Omaha

METASTATIC





 Breast

 Phase I/II trial of IMC-A12 in combination with Temsirolimus in patients with metastatic breast cancer (  8129)

 I/II

 Marcia Grafe                   402-483-2827 mgrafe@lmep.com

 Lincoln Medical Education Partnership Lincoln, NE

 Breast

 Phase I/II Study of Panobinostat (LBH589) and Letrozole in Patients
with Triple Negative Metastatic Breast Cancer (N093B) TEMPORARILY SUSPENDED
4/10/13"

 I/II

 Marcia Grafe                    402-483-2827 mgrafe@lmep.com

 Lincoln Medical Education Partnership Lincoln, NE

 Breast

 A Phase II Prospective Trial Correlating Progression Free Survival with CYP2D6 Activity in Patients
with Metastatic Breast Cancer Treated with Single Agent Tamoxifen (E3108) *Suspended effective
6/21/13"

 II

 Natasha Wilson, nwilson@mvcc.cc

 402-991-8070 x203

---------------------------------

Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com 

 Missouri Valley Cancer Consortium, Omaha, NE;  Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE

 Breast

 "A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in
Patients with Metastatic Breast Cancer (E2108)"

 III

Natasha Wilson, nwilson@mvcc.cc

 402-991-8070 x203

---------------------------------

Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com 

 Missouri Valley Cancer Consortium, Omaha, NE;  Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE

Breast 

A Phase III trial to compare the safety and efficacy of Lapatinib plus trastuzumab plus an Aromatase inhibitor (AI) versus trastuzumab plus an AI versus Lapatinibplus an AI as first-line therapy in postmenopausal subjects with hormone receptorpositive, HER2-positive metastatic breast cancer (MBC) who have receivedtrastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting
(GlaxoSmithKline EGF114299)

III

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

 

Nebraska Methodist Hospital,
Omaha

 Breast

 Phase I/II trial of IMC-A12 in combination with Temsirolimus in patients with metastatic breast cancer (8129)

 I/II

 Natasha Wilson, nwilson@mvcc.cc

 402-991-8070 x203

 Missouri Valley Cancer Consortium, Omaha, NE

 Breast

 Phase I/II Study of Panobinostat (LBH589) and Letrozole in Patients with Triple Negative Metastatic Breast Cancer (N093B)

 I/II

 Natasha Wilson, nwilson@mvcc.cc

 402-991-8070 x203

 Missouri Valley Cancer Consortium, Omaha, NE

Breast

 A Multicenter, Randomized, Double Blind, Placebo controlled, Phase II Trial Evaluating the Safety and Efficacy of TKI258 Combined with Fulvestrant, in Postmenopausal Patients with HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy (HOG CTKI258A2210)


Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

 Nebraska Methodist Hospital,
Omaha NE

 Breast

Improving Fatigue and Sleep in Breast Cancer Survivors

 II

 Deborah Meyer, RN, BGS

 (402) 559-6941

dmeyerk@unmc.edu  or Ann Berger

 Nebraska Medical Center, Omaha, NE

 Breast

A Randomized, Double-Blind, Placebo Controlled, Phase II Study of BKM120 plus Pacilitaxel in Patients with HER2 negative Inoperable Locally

Advanced or Metastatic Breast Cancer, with or Without P13K Pathway Activation

 II

 Deborah Meyer, RN, BGS

 (402) 559-6941

dmeyerk@unmc.edu  or Mary Mailliard

 

 

 Nebraska Medical Center, Omaha, NE

 

 

 

 

 

 Breast

 A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Daily Everolimus in Combination with Trastuzumab and

Vinorelbine, in Pretreated Women with HER2/NEU Over-Expressing Locally Advanced or Metastatic Breast Cancer

 III

 Deborah Meyer, RN, BGS

 (402) 559-6941

dmeyerk@unmc.edu  or Kim Shields

 Nebraska Medical Center, Omaha, NE

 Breast

Single –Blind, Placebo-Controlled, Randomized Study of GDC-0941 in Combination with Paclitaxel versus Paclitaxel in Patients with Locally Recurrent or Metastatic Breast Cancer (USOR 12179)

 II

 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha

 

A randomized, multicenter, double blind Phase 3 study of PD-0332991 (Oral CDK 4/6 Inhibitor) plus Letrozole vs. Placebo plus Letrozole for the treatment of postmenopausal women with ER (+), Her2 (-) Breast Cancer who have not received any prior systemic anti-cancer treatment for advanced disease (Pfizer/TRIO A5481008)

 

 

Rebecca Hadenfeldt, RN, BSN

Clinical Research Nurse

Cancer Treatment Center

P: 308-398-6783

F: 309-398-3219

 Saint Francis Cancer Treatment Center, Grand Island, NE

 

A randomized multicenter, double-blind, placebo-controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancer (CALGB-A211201)

 

 Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com 

 Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE

 

 Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

 III

 Candice Toombs, RN candicet@leadingcancercare.com 402-327-7363

 Southeast Nebraska Cancer Center, Lincoln, NE


 A Randomized, Double-blind Phase II study of Ruxolitinib or placebo in combination with capecitabine in subjects with advanced or metastatic HER2-Negative breast cancer

II

 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha


 A Multicenter, Randomized, Double Blind, Placebo controlled, Phase II Trial Evaluating the Safety and Efficacy of TKI258 Combined with Fulvestrant, in Postmenopausal Patients with HER2- and HR+ Breast Cancer That Have Evidence of Disease Progression on or After Prior Endocrine Therapy (HOG CTKI258A2210)

 II

Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250

Nebraska Methodist Hospital,
Omaha NE


A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients(EORTC-1307-BCG, BIG5-13, PR-30-5010-C)

III

 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha


A Phase II, Multicenter, Randomized, Parallel Group Study to Compare Inhibition of Aurora A Kinase with Alisertib in Combination with Paclitaxel vs. Paclitaxel Alone in Progression-free Survival in Patients with Metastatic or Locally Recurrent Breast Cancer

II

 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha


A randomized, double-blind, placebo-controlled, Phase 3 study of fulvestrant with or without LY2835219, a CDK4/6 Inhibitor, for Women with Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer and Disease Progression after Prior Endocrine Therapy


 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha


A Randomized, Multicenter, Open Label Study of MM-302 plus Trastuzumab vs. Chemotherapy of Physician’s Choice plus Trastuzumab in Anthracycline Naive Patients with Locally Advanced/Metastatic HER2-Positive Breast Cancer


 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha


A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects with bone metastases treated with hormonal treatment background therapy

II

 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha


PUMA-NER-1301: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More PriorHER2-Directed Regimens in the Metastatic

Setting (NALA)



Lisa Pfeifer RN
lisa.pfeifer@nmhs.org
402-354-8250


Nebraska Methodist Hospital,
Omaha


ALTernate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant TrEatment (ALTERNATE) in postmenopausal women: A Phase III Study ( Alliance   011106) NCT01953588




OTHER





 Breast

Single –Blind, Placebo-Controlled, Randomized Study of GDC-0941 in Combination with Paclitaxel versus Paclitaxel in Patients with Locally Recurrent or Metastatic Breast Cancer (USOR 12179)

 II

 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha

 Breast

Improving Fatigue and Sleep in Breast Cancer Survivors

 II

 Deborah Meyer, RN, BGS

 (402) 559-6941

dmeyerk@unmc.edu  or Ann Berger

 Nebraska Medical Center, Omaha, NE


Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity (Non-Hispanic White Enrollment Arm Closed)(WFU-97609)

 

 Nebraska Cancer Research Center – Kelly Madcharo – kmadcharo@lmep.com 

Nebraska Cancer Research Center/ Lincoln Medical Education Partnership Lincoln, NE

 Breast

Duloxetine Hydrochloride to Treat Muscle, Bone, and Joint Pain in Pts W/Early-Stage Breast Cancer Receiving Hormone Therapy (S1202)

 

 Kimberly Kaberle

210-6148808 x 1022

kkaberle@swog.org

 Good Samaritan Cancer Center

 Breast

 A Breast Cancer Information Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer (BCCR)

 

 Elizabeth Fleissner RN BSN

402-559-8197

eafleissner@unmc.edu

 Good Samaritan Cancer Center


Scalp Cooling Alopecia Prevention Trial (SCALP)



 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha



 

 


 


NON INTERVENTIONAL: A Phase II: Characterization of Circulating Tumor Cells from Subjects with Metastatic Breast Cancer using the CTC Endocrine Therapy Index


 Faye Park, fpark@nebraskacancer.com, 402-691-6972

 Nebraska Cancer Specialists, Omaha


Ncs updated 9/21/14

Methodist updated 9/23/14

CHI Updated 12/4/14




Nebraska Oncology Society
c/o Nebraska Medical Association
Sarah Dunbar
Executive Director
233 South 13th Street Suite 1200
Lincoln, NE 68508
sarahd@nebmed.org (email)
402-474-4472 (phone)
402-474-2198 (fax)

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