Breast Cancer Clinical Trials

17 trials identified.

Neratinib for Metastatic HER2 Mutation Breast Cancer [WASHU]
Principal Investigator: Kimmick, Gretchen
Protocol Number: PRO00045798

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Metastatic HER2 Negative Breast Cancer
What is the Purpose of this Study?
This 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 (study drug). 
Who Can Participate in the Study?
Adults who:
- Have Stage IV (4), HER2 negative breast cancer 
- Have tested positive for the HER2 mutation. 

There is no limitation on the number of prior lines of chemotherapy. 
What is Involved?
If you choose to join this study, you will:
- Submit a previously collected breast tissue sample to be tested for HER2 mutation status
--- If you have the HER2 mutation, you will continue onto the study and get a daily dose of the study drug, neratinib in 28day cycles until your disease gets worse, you show bad side effects, or your doctor doesn't want you to be in the study anymore. 
-Have tests, exams, and procedures that are part of your standard care and for study purposes
Participating Institutions:
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

NRG-BR002 for Oligometastatic Breast Cancer
Principal Investigator: Salama, Joseph
Protocol Number: PRO00061007

Age Group: Adult
Scope: National

Phase: II/III (Cancer Control)
Disease Site: Breast

Contact: DCI Clinical Research Team, Radiation Oncology
Email:

What is the Condition Being Studied?
Oligometastatic Breast Cancer
What is the Purpose of this Study?
We are doing this study to compare any good or bad effects of delivering ablative local therapy to ALL known metastatic tumor sites,  (even those that are not causing symptoms); in addition to the usual approach of intravenous or oral medications for treatment of breast cancer that has spread up to 4 body sites. 
Who Can Participate in the Study?
Adult women with breast cancer which has spread who:
- Are not pregnant or nursing
What is Involved?
If you agree to be in the study, you will:
- Be randomized (put into one of two groups by chance like a flip of a coin) and receive either:
Group 1 - usual treatment for metastatic breast cancer which is oral or intravenous medications and may include surgery, radiation, and other methods.
Group 2 - receive the usual treatment for metastatic breast cancer which is oral or intravenous medications PLUS ablative local therapy (SBRT or surgical resection) to all known metastatic sites.
Participating Institutions:
  • Duke University Health System : Radiation Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

NSABP B-55/BIG 6-13 for BRCA1/2 Mutations and High Risk HER2 Negative Breast Cancer
Principal Investigator: Marcom, P Kelly
Protocol Number: PRO00061408

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Breast cancer
What is the Purpose of this Study?
We are doing this study to find out how safe and effective the drug called olaparib  is with additional approaches to keep cancer from returning.  After treatment is complete you will be watched for side effects and your condition monitored for 10 years.
Who Can Participate in the Study?
Adults 18 years or older, who:
- Have undergone surgery and received adjuvant chemoterapy
- Have undergone neoadjuvant chemotherapy followed by surgery
- Have histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast 
- Have BRCA mutation
What is Involved?
If you agree to be in the study, you will:
- Be tested for a BRCA mutation - requires a sample of tissue from your previous biopsy/surgery
- Be randomized (put into one of two groups by chance like the flip of a coin) to receive study drug or placebo
-- Take your assigned treatment (olaparib or placebo) for about 12 months
- Have a blood test before, during, and after your treatment period
- Have an electrocardiogram (ECG)
Participating Institutions:
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

TBCRC034: Ductal Carcinoma in Situ
Principal Investigator: Hwang, Eun-Sil
Protocol Number: PRO00066589

Age Group: Adult
Scope: National

Phase: N/A
Disease Site: Breast; Unknown Sites

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Breast Cancer (flat epithelial atypia (FEA), intraductal papilloma without atypia (IPWA))
What is the Purpose of this Study?
Flat epithelia atypia (FEA) and intraductal papilloma without atypia (IPWA) are changes seen within the milk ducts. We are able to catch this diagnosis easier due to core needle biopsies, which is an accurate method that does not involve surgery. 

We are doing this study to see how often cancer is found by surgical biopsy, after the original core needle biopsy was done that diagnosed the FEA or IPWA. We hope these findings will help doctors to better advise you on whether to get a surgical biopsy to get rid of your cancer. 
Who Can Participate in the Study?
Adult women who have been diagnosed with flat epithelial atypia (FEA) or intraductal papilloma without atypia (IPWA) by core needle biopsy and no prior history of invasive breast cancer or ductal carcinoma in situ (DCIS). 
What is Involved?
If you agree to be in this study, you will:

- Confirm that a core needle biopsy was done and it showed FEA or IPWA. 
- Have tests, exams, scans, and answer questionnaires.
- Be randomized (put into one of two groups by chance like a flip of a coin) to get either
--- Group 1: surgery up to 6 months from diagnosis - this is a procedure where the area of the breast tissue to have the FEA or IPWA is removed by the surgeon.
--- Group 2: physical exams and breast tissue analysis - up to 3 months after surgery. 
- Be in the study for up to 9 months

Participating Institutions:
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Improving Well-Being for Breast Cancer Patients
Principal Investigator: Shelby, Rebecca
Protocol Number: PRO00068595

Age Group: Adult
Scope: National

Phase: N/A
Disease Site: Breast

Contact: Willis, Michael
Phone:

What is the Condition Being Studied?
Breast Cancer
What is the Purpose of this Study?
We are doing this study to learn how well two different programs work to help improve well-being among women taking a medication that lowers the chance of their breast cancer coming back.
Who Can Participate in the Study?
Adult women who have:
- Been diagnosed with stage I to III breast cancer 
- Completed other cancer treatments (such as surgery, chemotherapy, and radiation) 
- Started taking breast cancer medication in the past 12 months 

If you need help understanding if you can participate in this study, please contact the study team.
What is Involved?
If you choose to join the study, you will: 

- Come in for 5 visits that last 1-2 hours each. 
-- During these visits, you will be asked to fill out questionnaires about your health and how you are feeling. The last visit will take place 18 months after the first visit. 

- Be randomized (like the flip of a coin) to receive one of two programs: 
-- One program focuses on skills that can be used to cope with the side effects of the breast cancer medication you are taking. -- The other program focuses on improving overall health and well-being. 
- Both programs involve 10 phone sessions with a study nurse, which are completed over 6 months. 

- Be asked to use a special pill bottle for 18 months that will help the study team track how often you are taking your breast cancer medication.


Participating Institutions:
  • Duke University Health System : Michael Willis
  • Johnston Health (Smithfield) : Michael Willis
  • Scotland Health Care System (Laurinburg) : Michael Willis
  • Southeastern Regional Medical Center (Lumberton) : Michael Willis
View this trial at ClinicalTrials.gov

Alliance A011502 for HER2 Breast Cancer
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00078530

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
HER2 Negative Breast Cancer
What is the Purpose of this Study?
We are doing this study to learn if using aspirin after completing the usual chemotherapy, surgery, and/or radiation therapy for breast cancer will lower the rate of the cancer returning. 
Who Can Participate in the Study?
Adults greater than 18 years of age but less than 70 years of age with HER2 negative breast cancer who do not have:
- A history of gastric or duodenal ulcers
- Gastrointestinal bleeding that required a blood transfusion or surgery
- A history of stroke
- To take blood thinners such as warfarin, heparin, clopidogrel or others
- A history of atrial fibrillation or heart attack
- Allergy to aspirin
- A history of metastatic breast cancer
- Uncontrolled hypertension
What is Involved?
If you choose to join this study, you will:
- Be assigned to one of two study groups (like the flip of a coin): 
-- One group will get aspirin and the other group will get a placebo (a pill that looks like the study drug but contains no medicine)
- Take the study drug (aspirin or placebo) every day for not more than 5 years
- See your study doctor every 6 months to talk about any side effects you may be having while taking the study drug
- Be given a medication log to record the date, time, and number of pills taken each day and list any side effects you may be having
Participating Institutions:
  • Duke Cancer Center Cary : Breast Oncology DCI Clinical Research Team
  • Duke Raleigh Hospital : Breast Oncology DCI Clinical Research Team
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Breast Oncology DCI Clinical Research Team
  • Johnston Health (Smithfield) : Breast Oncology DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Breast Oncology DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Breast Oncology DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

COMET: Ducal Carcinoma in SITU
Principal Investigator: Fayanju, Oluwadamilola
Protocol Number: PRO00080888

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Breast

Contact: Downing, Cynthia

What is the Condition Being Studied?
Ductal Carcinoma in Situ (DCIS)
What is the Purpose of this Study?
We are doing this study to compare the risks and benefits of the usual treatment approach for DCIS with a close disease- monitoring approach. 
Who Can Participate in the Study?
Adult women over age 40 who:
- Have a new diagnosis of DCIS without invasive cancer
- Have no prior history of breast cancer in either breast
What is Involved?
If you choose to join this study, you will:
- Be randomized (like a flip of a coin) into one of two treatment groups: 
--- Group 1 will get traditional treatment with radiation, surgery, and chemotherapy
--- Group 2 will have close monitoring of their disease with possible chemotherapy

- Have tests, exams, and procedures that are part of your standard of care and for study purposes
Participating Institutions:
  • Duke University Health System : Breast Oncology DCI Clinical Research Team, Cynthia Downing
View this trial at ClinicalTrials.gov

Patina: Targeted Therapy + Palbociclib for Metastatic Breast Cancer
Principal Investigator: Westbrook, Kelly
Protocol Number: PRO00082159

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
HER2 Positive, ER Positive Breast Cancer
What is the Purpose of this Study?
We are doing this study to see if adding the study drug, palbociclib, to your current anti-HER2 cancer therapy and your endocrine therapy is better than anti-HER2 therapy plus endocrine therapy alone for people with breast cancer. 

We would like to know what effects, good or bad, palbociclib has on cancer by comparing it to current standard of care therapy, which is the combination of anti-HER2 and endocrine therapy. 
Who Can Participate in the Study?
- Adult women and men with metastatic (spread to other places on the body), HER2 positive, hormone receptor positive breast cancer. 
- Adults must have a disease-free period for at least 6 months after completing anti-HER2 cancer therapy before getting the metastatic breast cancer diagnosis.  
What is Involved?
If you agree to be in the study you will:
- Be randomized (put into one of two groups by chance like a flip of a coin)to get either:
--- Group 1: palbociclib (study drug), your current anti-HER2 cancer therapy (such as trastuzumab or pertuzumab) and endocrine therapy (such as letrozole or fulvestrant).
--- Group 2: Only get current anti-HER2 cancer therapy (such as trastuzumab or pertuzumab) and endocrine therapy (such as letrozole or fulvestrant). 
- Have tests, exams, and procedures that are part of your standard care and for study purposes. 
- Continue to receive the study drug as long as there are no bad side effects and the cancer does not become worse. 
- Be in the study for 5 years after starting the study drug.
Participating Institutions:
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

PVSRIPO Bioactivity Triple Negative Breast Cancer
Principal Investigator: Hwang, Eun-Sil
Protocol Number: PRO00085352

Age Group: Adult
Scope: Local

Phase: Pilot
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Triple Negative Breast Cancer
What is the Purpose of this Study?
We are doing this study to learn how the study drug called PVSRIPO works and to see how it affects breast cancer tumors. 
Who Can Participate in the Study?
Adult women who:
- Have stage II-IV triple negative breast cancer who are planning to have surgery
- Have had their last dose of chemotherapy at least 3 weeks before the vaccine 
What is Involved?
If you choose to join this study, you will:

- Get a polio virus vaccine booster shot
- Have a biopsy of your tumor 7-10 days after the vaccination
- Have the study drug (PVSRIPO) injected directly into your breast tumor
- Have surgery to remove your tumor about 2 weeks after the PVSRIPO injection
- Have blood tests and stool sample collected for research

- Have follow-up contacts at 2 days, one month and 6 months after PVSRIPO injection
Participating Institutions:
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Fox Chase BR-076: Pembrolizumab for Triple Negative Metastatic Breast Cancer
Principal Investigator: Force, Jeremy
Protocol Number: PRO00086335

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Triple Negative Metastatic Breast Cancer
What is the Purpose of this Study?
We are doing this study is to see if the study drug, pembrolizumab, plus chemotherapy (carboplatin and gemcitabine) is safe and effective in treating people with metastatic triple negative breast cancer. 
Who Can Participate in the Study?
Adult women who :
- Have metastatic, triple negative breast cancer (spread to other parts of your body).
- Have already received up to 2 cancer therapies for their metastatic breast cancer 
- Are candidates for chemotherapy with carboplatin and gemcitabine. 
What is Involved?
If you join this study, you will be randomly put into a study group, like drawing numbers out of a hat.

- If you are in group 1, you will get pembrolizumab along with chemotherapy (carboplatin and gemcitabine).
- If you are in group 2, you will receive chemotherapy (carboplatin and gemcitabine) alone. 

- You will have tests, exams, and procedures that are part of your standard of care and for study purposes.
- You will be asked to take the study drugs for up to 2 years. You will be followed until the study ends. 
Participating Institutions:
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

TMIST Mammography Study (Breast Cancer Screening)
Principal Investigator: Grimm, Lars
Protocol Number: PRO00086885

Age Group: Adult
Scope: National

Phase: III
Disease Site: Breast

Contact: DCI Clinical Research Team, Radiation Oncology
Email:

What is the Condition Being Studied?
Breast cancer
What is the Purpose of this Study?
We are doing this study to compare two different screening mammography methods in pre- and post-menopausal women to understand whether one method is better than the other at finding life-threatening breast cancers.
Who Can Participate in the Study?
Women aged 45 to 74
What is Involved?
If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to screening with Tomosynthesis Mammography (TM) or Digital Mammography (DM) 

The frequency and number of screening mammograms will vary with your menopausal status and whether you have breast cancer risk factors.  
-- All premenopausal women will have annual screening

-- Postmenopausal women will have screening every 2 years unless they have any specific risk factors

- Have either three-dimensional (3D) Tomosynthesis Mammography or two-dimensional (2D) Digital Mammography

-- Get screened every year for four more years - for a total of five mammograms, or
-- Every other year - for a total of three mammograms

- Be followed for 4.5 to 8 years
Participating Institutions:
  • Duke University Health System : Radiation Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

TBCRC039: Inflammatory Triple Negative Breast Cancer
Principal Investigator: Force, Jeremy
Protocol Number: PRO00092397

Age Group:
Scope:

Phase: II
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Triple Negative, Inflammatory Breast Cancer
What is the Purpose of this Study?
We are studying to see if the study drug, ruxolitinib, is a possible treatment for Inflammatory Breast Cancer. 
The following drugs will be used with ruxolitinib:
- paclitaxel (also called Taxol)
- doxorubicin (also called Adriamycin)
- cyclophosphamide (also called Cytoxan)
Who Can Participate in the Study?
Both men and women above 18 years of age with triple negative, inflammatory breast cancer. 
What is Involved?
If you join this study, you will get the study drug ruxolitinib plus the approved cancer drug paclitaxel. You will then get the standard chemotherapy drugs, doxorubicin and cyclophosphamide.

- Paclitaxel, doxorubicin, and cyclophosphamide are approved drugs for the treatment of breast cancer. 

- A core needle biopsy of your breast tissue will be done before starting therapy.

- You will have tests, exams, and procedures that are part of your standard care and for study purposes. 
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Breast Oncology DCI Clinical Research Team
  • Duke Primary Care : Breast Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Breast Oncology DCI Clinical Research Team
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

TBCRC041: Alisertib for Endocrine-resistant Breast Cancer
Principal Investigator: Marcom, P Kelly
Protocol Number: PRO00093260

Age Group: Adult
Scope:

Phase: II
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Advanced, Endocrine-Resistant Breast Cancer
What is the Purpose of this Study?
We are doing this study to find out how well the study drug, alisertib with or without fulvestrant (approved drug for breast cancer) works in treating women with endocrine-resistant breast cancer that has spread to other places in the body. 
Who Can Participate in the Study?
Post-menopausal women who have: 
- Hormone receptor positive breast cancer
- HER2 negative breast cancer
- Metastatic or locally advanced cancer

- Not had more than 2 other cancer therapies before starting this study.
- Already had treatment with fulvestrant in the metastatic setting (cancer spread to other parts of the body)
- Not had treatment with alisertib before
What is Involved?
If you choose to join this study, you will
- Be randomized (like a flip of a coin) into one of two treatment groups:
--- Study Group One will take the study drug, alistertib, alone
--- Study Group Two will take the study drug, alistertib and the approved breast cancer drug, fulvestrant. 

- Return to Duke Clinic every 28 days for physical exam, blood tests, and scans (as needed) to see how you are doing and to receive the next doses of the study drug. 
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Breast Oncology DCI Clinical Research Team
  • Duke Primary Care : Breast Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Breast Oncology DCI Clinical Research Team
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Concurrent VRP-HER2 Vaccine + Pembrolizumab for HER2+ Breast Cancer
Principal Investigator: Morse, Michael
Protocol Number: PRO00100093

Age Group: Adult
Scope:

Phase: II
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Advanced HER2+ breast cancer receiving Trastuzumab and Pertuzumab
What is the Purpose of this Study?
We are doing this study to find out if the study vaccine, VRP-HER2, alone or when given with pembrolizumab is safe and has good effects in people with HER2 positive breast cancer. 
Who Can Participate in the Study?
Adult men and women with hormone receptor negative, HER2 positive, metastatic breast cancer who are getting trastuzumab and pertuzumab. 
What is Involved?
If you choose to be in the study, you will:

Be randomly assigned (like the flip of a coin) to one of three study groups: 
-- Group A: will get the study vaccine VRP-HER2 by itself 
-- Group B: will get pembrolizumab by itself 
-- Group C: will get VRP-HER2 plus pembrolizumab together

If you are one of the first 3 patients to be in this study, you will not by randomly assigned and will get VRP-HER2 plus pembrolizumab together.

Depending on the group you are assigned to, you will be asked to return to the Duke Clinic for study drug dosing, physical exams and other tests about 7-10 times over 6 months. 

You will also have two biopsies of your tumor tissue; one before you get study drug, and one after the last dose of study drug. 
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Breast Oncology DCI Clinical Research Team
  • Duke Primary Care : Breast Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Breast Oncology DCI Clinical Research Team
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Metastatic Breast Cancer with BRCA gene mutation
Principal Investigator: Marcom, P Kelly
Protocol Number: PRO00100188

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Metastatic Breast Cancer, BRCA gene mutation
What is the Purpose of this Study?
We are doing this study to find out if the study drug olaparib is safe and will work for men and women with metastatic breast cancer with a BRCA gene mutation.
Who Can Participate in the Study?
Adults who have:
- Stage IV metastatic breast cancer 
- BRCA gene mutation (germline mutation or a somatic mutation)
--- If you have the mutation, you may not have progressed (gotten worse) on more than 2 chemotherapy regimens in the metastatic setting
What is Involved?
If you choose to join this study, you will:
- Get the study drug olaparib during each 21 day treatment cycle 
- Have tests, exams and procedures that are part of your standard of care and for study purposes. 
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Breast Oncology DCI Clinical Research Team
  • Duke Primary Care : Breast Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Breast Oncology DCI Clinical Research Team
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

DORA: Platinum Treated Triple Negative Breast Cancer
Principal Investigator: Sammons, Sarah
Protocol Number: PRO00100294

Age Group: Adult
Scope:

Phase: II
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Breast Cancer - Metastatic Triple Negative
What is the Purpose of this Study?
We are doing this study to learn how well a study drug, called olaparib, works in triple negative breast cancer that has responded to platinum chemotherapy (cisplatin or carboplatin) when it is given alone or when it is combined with durvalumab (another investigational drug).

Triple negative breast cancer means that the cancer cells tested negative for estrogen receptors (ER-), progesterone receptors (PR-), and human epidermal growth factor receptor 2 (HER2).

We hope the information learned from this study will help doctors understand more about olaparib and durvalumab as potential drugs for breast cancer therapy. 
Who Can Participate in the Study?
Women age 21 or older who:
- Have breast cancer that is metastatic (has spread) and is triple negative (does not have high levels of HER2 or HR proteins)
- Are currently receiving treatment with cisplatin or carboplatin
What is Involved?
If you choose to join this study, you will:
- Be randomly assigned (like the flip of a coin) to one of two treatment groups:
--- Olaparib alone or 
--- Olaparib in combination with durvalumab 
- Get every 28 days

- Come to the Duke Cancer Center clinic every 4 weeks for a physical exam, blood test, to see how you are doing and to get the next dose of study drug(s). 

Each clinic visit will last 1-8 hours. 

You can stay in the study for as long as the study drugs appear to the study doctor to be working for you.
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Breast Oncology DCI Clinical Research Team
  • Duke Primary Care : Breast Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Breast Oncology DCI Clinical Research Team
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov

TBCRC045-AVIATOR for HER2+ Metastatic Breast Cancer
Principal Investigator: Westbrook, Kelly
Protocol Number: PRO00100629

Age Group: Adult
Scope:

Phase: II
Disease Site: Breast

Contact: DCI Clinical Research Team, Breast Oncology
Email:

What is the Condition Being Studied?
Breast Cancer
What is the Purpose of this Study?
We are doing this study to test if 3 different drug combinations will work in people with metastatic HER2 positive breast cancer.
Who Can Participate in the Study?
Women with HER2 positive metastatic breast cancer who:
- Previously had treatment with ado-trastuzumab emtansine (Kadcyla, T-DM1) in any setting 
- Have previously gotten trastuzumab and pertuzumab in the metastatic setting
- Had their disease get worse during their most recent line of therapy 
What is Involved?
If you choose to join the study, you will:

- Be randomized (as in pulling numbers from a hat) into one of three groups: 
-- Group A: will get trastuzumab and vinorelbine combined
-- Group B: will get trastuzumab, vinorelbine, and avelumab combined 
-- Group C: will get trastuzumab, vinorelbine, avelumab and utomilumab combined 

- Have a biopsy before starting therapy, as well as Cycle 3 Day 1 

- Have blood drawn at every other cycle to test for biomarkers
Participating Institutions:
  • Duke Center for Living/Sarah Stedman Nutrition : Breast Oncology DCI Clinical Research Team
  • Duke Primary Care : Breast Oncology DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Breast Oncology DCI Clinical Research Team
  • Duke University Health System : Breast Oncology DCI Clinical Research Team
View this trial at ClinicalTrials.gov