CLINICAL TRIAL

HER-2 pulsed DC1 for Breast Cancer

Stage I
Recruiting · 18+ · All Sexes · Tampa, FL

Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

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About the trial for Breast Cancer

Eligible Conditions
Breast Neoplasms · HER2-positive Breast Cancer

Treatment Groups

This trial involves 3 different treatments. HER-2 Pulsed DC1 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
HER-2 pulsed DC1
BIOLOGICAL
+
Trastuzumab
DRUG
+
Paclitaxel
DRUG
+
Pertuzumab
DRUG
+
Resection surgery
PROCEDURE
Experimental Group 2
HER-2 pulsed DC1
BIOLOGICAL
+
Trastuzumab
DRUG
+
Paclitaxel
DRUG
+
Pertuzumab
DRUG
+
Resection surgery
PROCEDURE
Experimental Group 3
HER-2 pulsed DC1
BIOLOGICAL
+
Trastuzumab
DRUG
+
Paclitaxel
DRUG
+
Pertuzumab
DRUG
+
Resection surgery
PROCEDURE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~9050
Paclitaxel
2011
Completed Phase 4
~5040
Pertuzumab
2015
Completed Phase 3
~7810

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have HER2+ breast cancer and your primary tumor is larger than 1 cm. show original
Candidate for neoadjuvant chemotherapy with Paclitaxel, Trastuzumab, Pertuzumab regimen followed by standard of care local therapy as determined by the treating physician
You have a performance status of 0 or 1. show original
Participants must have normal organ and marrow function as defined per protocol.
Cardiac ejection fraction within institutional normal limits by either Multigated Acquisition Scan (MUGA) or Echocardiogram at baseline.
Women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery.
You are able to understand the nature and risks of the study and are willing to sign a written informed consent document. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 3 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether HER-2 pulsed DC1 will improve 2 primary outcomes and 4 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of at 12 months.

Expansion Phase: Radiologic tumor response rate at completion of therapy
AT 12 MONTHS
Radiologic tumor response rate measured by MRI
AT 12 MONTHS
Expansion Phase: Immunogenicity
AT 12 MONTHS
Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
AT 12 MONTHS
Expansion Phase: Pathologic Complete Response Rate
AT 12 MONTHS
Pathologic complete response rate of participants treated in the Expansion Phase. Clinical efficacy will be defined by the pathologic complete response (pCR) rate, the percentage of patients who achieve pCR based on surgical pathology assessment. Pathologic Complete Response defined as no residual invasive disease in the breast and nodes (ypT0/is N0) at definitive surgery after completion of protocol therapy. The pathologic response to treatment will be assessed by the pathologist. The "Residual Cancer Burden" (RCB) for each patient as described in the online calculator also will be evaluated per the pathologist. (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3)
AT 12 MONTHS
Expansion Phase: Radiologic tumor response rate after 6 weeks
AT 6 WEEKS
Radiologic tumor response rate measured by MRI
AT 6 WEEKS
Lead in Phase: Immunogenicity of each dose level
AT 4 WEEKS
Immunogenicity: will be characterized by quantifying CD4TH1 response via ELISPot. ELISPot is an enzyme-linked immunospot assay. It is a highly sensitive immunoassay that measures the frequency of cytokine-secreting cells at the single-cell level.
AT 4 WEEKS
Recurrence Free Survival
UP TO 3 YEARS
Recurrence free survival defined as the length of time after treatment that patient survives without any signs or symptoms of cancer.
UP TO 3 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes breast cancer?

The risk of developing breast cancer is linked to many environmental exposures. Certain lifestyle factors, such as not exercising and smoking, are also linked to increased risk. Women have a higher chance of developing breast cancer if their family has breast cancer (particularly, an extended family member). Genetic factors can increase the chances of breast cancer as well. Women with BRCA mutations have a 2- to 3-fold increased risk of developing breast cancer, compared to those without the family history for breast cancer. There are currently no cures for breast cancer and treatment often consists of surgery, chemotherapy and/or radiation therapy.

Anonymous Patient Answer

How many people get breast cancer a year in the United States?

The American Cancer Society estimates there will be a total of nearly 1 million new diagnoses of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in 2016. The 5-year survival rate for breast cancer patients is 91.7%. women die of breast cancer at a rate of over 1 in 10 every year in the United States.

Anonymous Patient Answer

What are common treatments for breast cancer?

The majority of women with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) have access to cancer treatment. The most frequent treatment for women with cancer is surgery. Chemotherapy is also frequently used to treat breast cancer.

Anonymous Patient Answer

What are the signs of breast cancer?

Findings from a recent study of the present study indicated that the use of the WHOBASQ in Iranian women presenting for breast cancer screening can have great potential in detecting women in early stages of breast cancer and improving their prognosis by facilitating diagnosis for early stage breast cancer and reducing the risk of breast cancer, and in particular, a decrease in the risk of developing early stage breast cancer and improving survival rates.

Anonymous Patient Answer

Can breast cancer be cured?

It is common for patients with sporadic breast cancer to be offered a palliative treatment such as mastectomy or chemotherapy. Survival time is improved by a good prognosis of the disease and the ability of patients to accept palliative treatment to increase quality of life.

Anonymous Patient Answer

What is breast cancer?

Breast cancer is the most common cancer that is diagnosed in women in the UK. About 75% of all sufferers develop [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) before the age of 50. It is a life-threatening disease in its early stages – women are advised to undergo routine screening of their breast health in order to spot cancer as early as possible.\n

Anonymous Patient Answer

What does resection surgery usually treat?

Almost any cancer can be cured with an excision of the tumor. The most common of its conditions, like a mammary gland tumor, is commonly resolved by an excision. The only condition under which the resection is seldom successful, and there may be a danger to the person, is to remove the nipple as part of the surgery (called a lumpectomy) for the treatment of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The treatment of breast cancer with the resections and lumpectomies is a surgery in which the surgeon removes the whole tumor instead of simply cutting it away with a knife. A doctor removes a part of the breast that may contain more cancer, and then performs an additional surgery to reconnect everything afterwards.

Anonymous Patient Answer

What are the common side effects of resection surgery?

Breast cancer surgery is one of the most challenging procedures because it requires very precise surgical judgment. Breast cancer patients' quality of life and cosmesis are more important to them than to their surgeons. Patient education and understanding of the procedure are crucial to the success of the surgery. The postoperative patient will be more likely to have pain after the surgery than before it. Postoperative pain can be controlled and managed with various analgesic methods. Patients should expect that pain during the first few days after the surgery will be very painful. Complications following breast cancer surgery include hematoma, seroma, infection, lymphedema, wound dehiscence, scar contracture, and nerve injury.

Anonymous Patient Answer

What is the primary cause of breast cancer?

Breast cancer is caused by environmental, hereditary, and lifestyle factors and their combined influence. Genetic causes include hereditary breast-cancer predisposition (see BRCA2 and BRCA1), and women who have the BRCA1 gene but not BRCA2 are at an increased risk, especially if they are also exposed to polycyclic aromatic hydrocarbons. Other risks include an increased likelihood of breast cancer among those who smoke, and the use of oral contraceptives in women younger than age 40.

Anonymous Patient Answer

What are the chances of developing breast cancer?

The chance of a woman developing breast cancer is 7% by age 30, 18% by 50 and 50% by age 60. The number of women who develop breast cancer by age 75 is approximately the same for both men and women: 2.3% for men and 2.5% for women. More specifically, the chance of developing breast cancer is 3.9% by age 35, 9.2% by 40, 23.3% by 45, 56.4% by 50 and 75% by age 75.

Anonymous Patient Answer

Who should consider clinical trials for breast cancer?

These participants understood what they were going to be part of and they were able to make well informed decisions about their participation. To address concerns about the impact of adjuvant therapy on quality of life, clinicians need to be more aware of these aspects when communicating with trial participants. Trials need to be designed to allow for the use of these aspects of people's lives to be included in measurement instruments, thereby allowing for a better understanding of the effect of treatment on quality of life.

Anonymous Patient Answer

What is resection surgery?

Once the MDs have assessed every aspect of the tumor the patient is scheduled for surgery. It’s important to choose someone who can have an operation to remove the tumor without too much risk of compromising your healing or even causing bleeding. It’s like you go in for surgery to have your knee replaced, but the surgeon decides to place the implant in your gluteus maximus muscle instead of in your knee joint. Or if you were having a hysterectomy, but then chose to have it all done together as an extra procedure, the doctor decides she wants to shave you down with an instrument instead of cutting you open. Then in the case of surgery it’s more of the same.

Anonymous Patient Answer
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