positron emission tomography for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
City of Hope, Duarte, CA
Breast Cancer+2 More
positron emission tomography - Procedure
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This study is evaluating whether a PET scan can help doctors to plan a better treatment for women with breast cancer.

See full description

Eligible Conditions

  • Breast Cancer
  • Carcinoma Breast Stage IV

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Breast Cancer

Study Objectives

This trial is evaluating whether positron emission tomography will improve 3 primary outcomes in patients with Breast Cancer. Measurement will happen over the course of 24 and 28 hours after injection of 64 CU-DOTA-trastuzumab.

Hour 28
Correlation of tumor uptake on 64Cu-DOTA-trastuzumab PET with tumor expression of HER2
Dose of pre-administered cold antibody that optimizes image quality of 64Cu-DOTA-trastuzumab PET
Relationship between uptake on 64Cu-DOTA-trastuzumab PET, HER2 overexpression, and inactivation of the PI3K/Akt pathway

Trial Safety

Safety Progress

1 of 3

Other trials for Breast Cancer

Trial Design

1 Treatment Group

Arm I
1 of 1
Experimental Treatment

This trial requires 18 total participants across 1 different treatment group

This trial involves a single treatment. Positron Emission Tomography is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm IPART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
copper Cu 64-DOTA-trastuzumab
2015
N/A
~10
positron emission tomography
2010
Completed Phase 2
~1200
mutation analysis
2008
Completed Phase 2
~3190
Biopsy
2011
Completed Phase 2
~1590

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 and 28 hours after injection of 64 cu-dota-trastuzumab
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 and 28 hours after injection of 64 cu-dota-trastuzumab for reporting.

Closest Location

City of Hope - Duarte, CA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Eligibility Part I (Determination of the cold dose)
Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
At least 1 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
The cancer must over express HER2 as determined by IHC and FISH.
Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
Participants must have normal cardiac ejection fraction.
Eligibility Part 2 (correlation of HER2 expression with PET uptake)
At least 1 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
Participants with HER2 1+, 2+ and 3+ by IHC are eligible.
Ineligibility

Patient Q&A Section

Can breast cancer be cured?

"Even in situations that are usually regarded as hopeless, there are some patients with breast cancer who can return to a normal life. The degree of disease control and survival depend on the initial stage of disease present at diagnosis. Results from a recent paper stresses the necessity of defining disease-free survival and the role of adjuvant therapy in breast cancer." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Changes to the breasts and skin; enlarged and tender lymph nodes; persistent vaginal bleeding, painful bowel movement and excessive urination; enlargement of the size, texture, and consistency of the nipples; or change in a woman's breast mobility are some of the signs of breast cancer. The most common type of mastectomy is mastectomies. If a woman has a family history of breast cancer, a full examination may help her to better understand her risks of developing breast cancer later in life.\n" - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"There is a genetic component to breast cancer, however, this is only one of many possible factors. Once a person has been diagnosed with breast cancer, they will need to have the appropriate treatment. Early detection is key to preventing further spread of the disease. Also, educating people on breast cancer risk factors will decrease the frequency with which people are diagnosed. Treatment of breast cancer is usually done through surgery, chemotherapy, hormonal therapy, or radiation therapy. Most of the time, early detection is done through mammography examinations." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is a cancer that forms in the breast tissue and also in the connective tissues of the body near where the breast lies. Breast cancer is an aggressive cancer, affecting mostly young people. Women are diagnosed with breast cancer when they are often not aware that they are being diagnosed with the condition. In the United States, when breast cancer is diagnosed, one in every four women is diagnosed via self-examination using the screening mammography process. To decrease the risk of breast cancer and to detect the disease at an early stage, women want and need good information about the disease." - Anonymous Online Contributor

Unverified Answer

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

"The prevalence of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the U.S. women exceeds the number of men dying of cancer. Women continue to die at very high rates of breast cancer in many U.S. communities; this cancer should be a national priority as it accounts for more deaths from cancer than either lung or colon cancer over an average of 9 years in all U.S. women. These high rates result from a population structure in which the women are older, have higher rates of smoking and lower rates of estrogen receptor and progesterone receptor positivity than has been observed in developed countries." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Treatment for breast cancer is based on the specifics of the type and stage of breast cancer, individual physicians, and individual preferences. Most patients have surgery or radiation therapy but some women choose alternate forms of treatment such as aromatase inhibitors, trastuzumab or targeted agents." - Anonymous Online Contributor

Unverified Answer

Is positron emission tomography typically used in combination with any other treatments?

"PET is a useful investigation and a useful addition to any other imaging modality routinely used in the assessment of newly diagnosed breast cancer. Both PET and conventional CT are also useful investigations in the staging of suspected recurrent breast cancer, mainly due to the high sensitivity of PET in detecting disseminated disease." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing breast cancer?

"The vast majority (83%) is diagnosed with early breast cancer (<or=63 years). There is no evidence of a difference in incidence by age at diagnosis." - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"Results from a recent clinical trial do not support the hypothesis that a genetic basis for breast cancer in women is found. Results from a recent clinical trial for all markers, regardless of significance level or effect size, did not consistently support an association. Overall there were only six (of 22) genetic signals that were identified. Because the most replicated studies focused on women who were diagnosed at a young age, it may not be surprising that there were no linkage signals detected. We found that the strongest links were between genes related to the endocrine signaling system, including the WNT pathway (e.g."

"Cherry Lake (Michigan)\n\nCherry Lake is an inland lake located in the U.S." - Anonymous Online Contributor

Unverified Answer

How quickly does breast cancer spread?

"There are many factors involved with cancer spread. They include tumor size, lymph node involvement, histology and hormone receptor status. However, most cancer spread in the lymph node is because of the direct extension of the cancer. A more conservative surgery can reduce the risk of cancer spread due to lymph node. Lymph node status in an early stage can help the doctor decide whether to treat the cancer by chemotherapy or radiation. The tumor can be measured by mammography and CT/MRI for early treatment and evaluation. By measuring the size of the tumor, the doctor can decide between medical treatment for lymph node negative breast cancer, watchful waiting or surgery to remove the cancer." - Anonymous Online Contributor

Unverified Answer

Does positron emission tomography improve quality of life for those with breast cancer?

"PECT improves QOL over CT. Results from a recent paper support PECT usage for patients with BCS who are considered medically high-risk with a high index of suspicion for the presence of breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"Newer [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) research findings on drugs with fewer side effects, gene therapy and stem cell medicine, have only started to emerge in recent years, but are beginning to translate into routine practice. Cancer prevention agents are now well established, and new ones are currently in the works. Cancer prevention agents such as BRCA1 gene therapy and the use of stem cell transplantation in cancer can save many lives. A new cancer vaccine was approved by the US FDA in May 2014. Breast implants are being used for cosmetic reasons. Moreover, breast cancer screening is being researched. The latest development in breast cancer treatment is targeted therapy. In many cases, targeted therapy proves effective in slowing a patient’s progression and is a great alternative to traditional chemotherapy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Breast Cancer by sharing your contact details with the study coordinator.