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Clinical Trials by Cancer Site

Breast Cancer

Breast cancer is a disease that occurs when malignant (cancer) cells form in the tissues of the breast. There are three main types of invasive breast cancer (cancer that has spread beyond the layer of tissue in which it developed and is growing into surrounding, healthy tissues).

  • Invasive ductal carcinoma: Begins in the ducts that carry breast milk and is the most common type of breast cancer (8 in 10 women with breast cancer have this type)
  • Invasive lobular carcinoma: Begins in the glands that make breast milk and is less common than invasive ductal carcinoma (1 in 10 women with breast cancer have this type)
  • Inflammatory breast cancer: Found in the lymphatic system of the skin of the breast and is an uncommon type of breast cancer (1 percent to 3 percent of all breast cancer diagnoses are inflammatory breast cancer)

In advanced cases, breast cancer cells may spread (metastasize) to other parts of the body via the blood stream or lymph system.

Excluding non-melanoma cancers of the skin, breast cancer is the most commonly diagnosed type of cancer among women in the United States. It is estimated that in 2012, there will be 226,870* new cases of invasive breast cancer in women and 2,190* cases in men.

Treatment options for breast cancer vary depending on the stage of the disease, previous treatment, and other medical conditions. Talk with your doctor about what treatment options may be available for you.

*American Cancer Society. Cancer Facts and Figures 2012. Atlanta: American Cancer Society; 2012

Breast Cancer Clinical Trials

The NCI Center for Cancer Research (CCR) conducts clinical trials at the NIH Clinical Center in Bethesda, Maryland. CCR is currently conducting the following trials for patients with breast cancer. Click on the trials below for additional details, including a summary of key eligibility criteria, study outline, and information on how to contact the principal investigators and their staff directly. For information on a particular trial or to discuss a screening visit, contact a member of the research team listed on the trial’s summary.

If you need further assistance, call our toll-free number at 1-888-NCI-1937 (1-888-624-1937) to be connected to a referral coordinator appropriate for your diagnosis.


  
Trial and Protocol Number
Breast Cancer
Phase II
A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
NCI-12-C-0087, NCT01480583

Principal Investigator:Referral Contact:
Susan BatesChristine Bryla
301-402-1357301-451-7868
brylacm@mail.nih.gov
Phase I
A Phase I Study With an Expansion Cohort of the PARP Inhibitor AZD2281 (KU-0059436) Combined With Carboplatin in Breast and Ovarian Cancer in BRCA 1/2 Mutation Carriers, Familial Breast and Ovarian Cancer, and Sporadic Triple Negative Breast Cancer and Ovarian Cancer
NCI-08-C-0092, NCT00647062

Principal Investigator:Referral Contact:
Elise C. KohnLaura D. Otten
301-402-2726301-451-1228
1-866-611-6310 (Toll Free)
ottenl@mail.nih.gov
No Phase
Characterization of High Risk Breast Duct Epithelium by Cytology, Breast Duct Endoscopy, and cDNA Gene Expression Profile
NCI-02-C-0077, NCT00070460

Principal Investigator:Referral Contact:
David N. Danforth
301-496-1533



  
Trial and Protocol Number
Liver Cancer
Phase I
A Phase I Dose Escalation Study of Hepatic Intra-Arterial Administration of TKM 080301 (Lipid Nanoparticles Containing siRNA Against the PLK1 Gene Product) in Patients With Colorectal, Pancreas, Gastric, Breast, Ovarian and Esophageal Cancers With Hepatic Metastases or Primary Liver Cancers
NCI-11-C-0240, NCT01437007

Principal Investigator:Referral Contact:
Udo RudloffMelissa Walker
301-496-3098301-402-8475
walkerme@mail.nih.gov


  
Trial and Protocol Number
Solid Tumor
Phase II
A Phase II Study of Enhancement of Immune Reconstitution and Vaccine Responses With Administration of Glyco-Recombinant Human IL-7 in Older Subjects Following Chemotherapy
NCI-11-C-0146, NCT01339000

Principal Investigator:Referral Contact:
Claude SportèsZetta Blacklock
301-435-5280301-594-2056
bblacklock@mail.nih.gov
Phase II Randomized Trial of the Combination of ABT-888 With Metronomic Oral Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low Grade Non-Hodgkin’s Lymphoma
NCI-11-C-0080, NCT01306032

Principal Investigator:Referral Contact:
Shivaani KummarJanelle Bingham
301-435-0517301-435-2715
jbingham@mail.nih.gov
A Multi-Histology Phase II Study of 5-Fluoro-2-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)
NCI-09-C-0214, NCT00978250

Principal Investigator:Referral Contact:
James H. DoroshowJanelle Bingham
301-496-4291301-435-2715
jbingham@mail.nih.gov
Phase II Study of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 TCR-Gene Engineered Lymphocytes
NCI-08-C-0121, NCT00670748

Principal Investigator:Referral Contact:
Steven A. RosenbergJune A. Kryk
1-866-820-4505 (Toll Free)1-866-820-4505
(Toll Free)
ncisbirc@mail.nih.gov
Phase I/II
Phase I/II Study of Metastatic Cancer that Expresses MAGE-A3/12 Using Lymphodepleting Conditioning Followed by Infusion of Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes
NCI-11-C-0062, NCT01273181

Principal Investigator:Referral Contact:
Steven A. RosenbergJune A. Kryk
1-866-820-4505 (Toll Free)1-866-820-4505
(Toll Free)
ncisbirc@mail.nih.gov
Phase I
An Open Label Phase I Study to Evaluate the Safety and Tolerability of GI-6301 Vaccine Consisting of Whole, Heat-killed Recombinant Saccharomyces Cerevisiae (Yeast) Genetically Modified to Express Brachyury Protein in Adults With Solid Tumors
NCI-12-C-0056, NCT01519817

Principal Investigator:Referral Contact:
James L. GulleyLaura D. Otten
301-435-2956301-451-1228
1-866-611-6310 (Toll Free)
ottenl@mail.nih.gov
Phase I Trial of Z-Endoxifen in Adults With Refractory Hormone Receptor-Positive Breast Cancer, Desmoid Tumors, Gynecologic Tumors, or other Hormone Receptor-Positive Solid Tumors
NCI-11-C-0061, NCT01273168

Principal Investigator:Referral Contact:
Shivaani KummarJanelle Bingham
301-435-0517301-435-2715
jbingham@mail.nih.gov
A Pharmacokinetic/Pharmacodynamic Study With a Phase I Run-In With a PARP Inhibitor (Olaparib) in Combination With Carboplatin for Refractory or Recurrent Women’s Cancers
NCI-11-C-0022, NCT01237067

Principal Investigator:Referral Contact:
Elise C. KohnLaura D. Otten
301-402-2726301-451-1228
1-866-611-6310 (Toll Free)
ottenl@mail.nih.gov
A Phase I, Dose Escalation Study of MGAH22 (Fc-optimized Chimeric Anti-HER2 Monoclonal Antibody) in Patients With Refractory HER2 Positive Breast Cancer and Patients With Other HER2 Positive Carcinomas for Whom No Standard Therapy is Available
NCI-10-C-0189, NCT01195935

Principal Investigator:Referral Contact:
Giuseppe GiacconeMichell J. Berg Manu
301-496-4916301-402-4423
manumichell@mail.nih.gov
A Pilot Study of EZN-2968, an Antisense Oligonucleotide Inhibitor of HIF-1alpha, in Adults With Advanced Solid Tumors
NCI-10-C-0113, NCT01120288

Principal Investigator:Referral Contact:
Shivaani KummarJanelle Bingham
301-435-0517301-435-2715
jbingham@mail.nih.gov
A Phase I Study of Dasatinib in Combination With Bevacizumab in Advanced Solid Tumors
NCI-09-C-0019, NCT00792545

Principal Investigator:Referral Contact:
Elise C. KohnLaura D. Otten
301-402-2726301-451-1228
1-866-611-6310 (Toll Free)
ottenl@mail.nih.gov
Phase 0
A Phase 0 Trial of [111] Indium CHX-A" DTPA Trastuzumab Imaging in Cancer
NCI-07-C-0101, NCT00474578

Principal Investigator:Referral Contact:
Peter ChoykeYolanda McKinney
301-402-8409301-443-6913
ymckinney@mail.nih.gov
No Phase
A Natural History Study of Patients Receiving High Dose Rate Brachytherapy
NCI-09-C-0100, NCT00924027

Principal Investigator:Referral Contact:
Aradhana KaushalSharon L. Smith
301-496-5457301-496-5457
smiths@mail.nih.gov
The Natural History of Solid Organ Cancer Stem Cells
NCI-09-C-0079, NCT00923052

Principal Investigator:Referral Contact:
Steven A. RosenbergMelissa Walker
1-866-820-4505 (Toll Free)301-402-8475
walkerme@mail.nih.gov


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