Breast Q for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Washington University School of Medicine, Saint Louis, MO
Breast Q - Other
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a thinner acellular dermal matrix may be more effective than a thicker one.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Breast Q will improve 1 primary outcome and 16 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of At the time of surgery.

At the time of surgery
Amount of tissue expander fill
Immediate implant type as measured by fill
Immediate implant type as measured by manufacturer
Immediate implant type as measured by shape
Immediate implant type as measured by surface characteristics
Immediate implant type as measured by volume (cc)
Up to 15 months
Comparison of direct hospital costs
Comparison of physician reimbursements
Degree of acellular dermal matrices (ADM) incorporation
Duration of drain use
Health related quality of life as measured by Breast Q
Incidence of analgesic use for pain
Incidence of infection as measured by presence or absence of cellulitis
Incidence of non-infectious complications
Incidence of premature tissue expander (TE) removal
Nature of second surgery as measured by type of surgery enrolled patients undergo to address their tissue expander after its initial insertion
Patient satisfaction as measured by Breast Q

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

No Control Group
Group A: Alloderm RTU

This trial requires 320 total participants across 2 different treatment groups

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

Group A: Alloderm RTUPrior to the date of mastectomy, the BREAST Q patient-reported outcome survey will be administered for routine clinical care purposes. It may occur before or after enrollment. On the day of surgery, patients will receive standardized preoperative care, a skin- or nipple-sparing mastectomy from an experienced surgical breast oncologists and immediate tissue expander breast reconstruction with Dr. Myckatyn or Dr. Tenenbaum. Uniform operative techniques will be used in both treatment groups. All patients will receive either a 16x8 cm (128 sq cm) ADM graft for postpectoral reconstruction or 16x20 cm (320 sq cm) for prepectoral reconstruction. Patients randomized to Group A will receive Alloderm RTU A post-operative version of the Breast Q validated in patients who have received tissue expanders will be administered between 1 and 3 months after tissue expander insertion, and again prior to exchange for an implant or flap (or at time of patient-requested removal
Group B: Cortiva 1mm Allograft DermisPrior to the date of mastectomy, the BREAST Q patient-reported outcome survey will be administered for routine clinical care purposes. It may occur before or after enrollment. On the day of surgery, patients will receive standardized preoperative care, a skin- or nipple-sparing mastectomy from an experienced surgical breast oncologists and immediate tissue expander breast reconstruction with Dr. Myckatyn or Dr. Tenenbaum. Uniform operative techniques will be used in both treatment groups. All patients will receive either a 16x8 cm (128 sq cm) ADM graft for postpectoral reconstruction or 16x20 cm (320 sq cm) for prepectoral reconstruction. Patients randomized to Group B will receive Cortiva 1mm Allograft Dermis A post-operative version of the Breast Q validated in patients who have received tissue expanders will be administered between 1 and 3 months after tissue expander insertion, and again prior to exchange for an implant or flap (or at time of patient-requested removal
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgery
1999
Completed Phase 3
~2060

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 15 months for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient's preoperative surgical plan includes the placement of a tissue expander, either subpectorally or prepectorally, with ADM. show original
The person is able to understand what they are consenting to, and is willing to sign an IRB-approved written document that explains the consent process. show original
Sex: Females
The study included people aged 22 to 70 years old. show original
There are two types of mastectomy: skin-sparing mastectomy and nipple-sparing mastectomy show original

Patient Q&A Section

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

Can breast cancer be cured?

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Because there have not been many controlled studies on treating [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) symptoms, it is not possible to state whether the symptoms can be improved, or whether they are unchanged, or improved after treatment for the cancer. In many cases, symptoms can improve (or worsen) and the disease status remains the same.

Unverified Answer

What are common treatments for breast cancer?

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Treatments for breast cancer may be classified as systemic agents and local treatments. Systemic agents such as antiestrogens are used in recurrent disease and can also be effective in prevention therapy. Local agents include radiation therapy and surgery.

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What is breast cancer?

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Breast cancer is the most common form of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). Signs such as lump in the breast, enlargement and nipple discharge may be detected on a regular basis by an experienced nurse or breast cancer counsellor. The symptoms often do not show up until an advanced stage of the disease. It is very important to seek treatment as early as possible.

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

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  1. About 100,000 new cases per year are diagnosed in the United States, where more than a third are diagnosed with the more distressing type. 2. Nearly 300 people get [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) diagnosed per year per 100,000 women. 3. More than 1.4 million women would be diagnosed with a cancer of their breast if it were not for mammography. 4. Half a million cases of breast cancer in the United States were diagnosed between the ages of 20 and 39 years because of the early widespread use of breast cancer screening. 5. Women older than age 50 are now more than twice as likely as younger women in the United States to develop breast cancer. 6.
Unverified Answer

What causes breast cancer?

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It has long been presumed that [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is a multifactorial disease, involving genetic and environmental factors operating in conjunction and also affecting different steps in the development of the disease. In recent years, the concept of mammary-tumor susceptibility has become widely accepted. As one of the major types of human cancer, the role and magnitude of the mammary-tumor susceptibility are crucial for understanding breast cancer development. A critical question is whether a specific factor is responsible for inducing breast cancer in individuals who probably lack this factor. The fact that breast cancer often occurs in patients with a family history of the disease and those with inherited alterations in several tumor suppressor genes or oncogenes and their signaling pathways (e.g.

Unverified Answer

What are the signs of breast cancer?

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In a population of women with no history of cancer, breast symptoms had a good diagnostic sensitivity and specificity for breast cancer, but a poor sensitivity to exclude it. All of the symptoms had very low negative predictive values. The occurrence of breast symptoms should be weighed against the occurrence of serious life-threatening conditions such as depression.

Unverified Answer

What are the common side effects of breast q?

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Almost all breast q users (98.9%) experienced at least one side effect, and most (99.9%) felt the side effects were mild. Overall, side effects were common, but most were not severe. Overall, we found that side effects were mild to moderate in terms of severity and frequency, whereas only 1.1% of users felt their side effects were severe. Most users said side effects did not bother them and they were still willing to use the app after a side effect.

Unverified Answer

Have there been any new discoveries for treating breast cancer?

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No new treatment has proved effective in reducing the risk of breast cancer death. Many studies found no association between breast cancer death rates and the use of Tamoxifen, an estrogen receptor antagonist.

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What is the primary cause of breast cancer?

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There is limited evidence that the primary cause of breast cancer is hereditary, with the exception for BRCA1 mutations. Breast cancer risk was higher with higher age and higher education. Among those women who had never been pregnant, no increased risk was noticed.

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What does breast q usually treat?

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Most patients are concerned about how their breast will look or that they cannot take care of themselves like they used to do before the surgery. A good understanding of the natural history of breast disease and counseling to address these concerns are critical for optimally assessing and treating patients who undergo breast surgery.

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Is breast q safe for people?

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The long-term follow up of this pilot population study does not support a risk of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) from breast self-examination. The risks of breast q are acceptable and may be acceptable given that it is an individualised decision taken by an informed patient and provided all the relevant options are discussed.

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Who should consider clinical trials for breast cancer?

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Clinicians could and should consider providing patient counseling about clinical trials for breast cancer when the likelihood of receiving a significant quality-of-life benefit is greater than the likelihood of experiencing harm. Physicians could and should consider considering clinical trials for breast cancer when: 1) patients are older than age 70 years and when 2) treatment has not proven to be effective, is no longer being evaluated, or has insufficiently progressed within 3 years. Physicians could and should consider considering clinical trials for breast cancer when 3.1 years have elapsed without an improvement in survival, and 4.1 years have elapsed since the diagnosis. Physicians could and should consider discussing clinical trials with patients when 5.2 years have elapsed since diagnosis or 5.

Unverified Answer
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