What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving surgical interventions like the use of Acellular Dermal Matrix (ADM) in breast reconstruction, can have several side effects. Surgical procedures may lead to complications such as infections, the need for tissue expander or implant removal, and other conditions requiring additional surgeries. Chemotherapy, often used in conjunction with surgery, can cause side effects including alopecia (hair loss), nausea, fatigue, and increased risk of infections. Radiation therapy, another common treatment, can result in skin irritation, fatigue, and long-term risks such as lymphedema. Each treatment modality carries its own set of potential side effects, and the choice of treatment should be tailored to the individual patient's condition and needs.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include a variety of drugs and therapies aimed at different stages and types of the disease. These include hormone therapies like tamoxifen and aromatase inhibitors, chemotherapy agents such as doxorubicin and paclitaxel, targeted therapies like trastuzumab (Herceptin) for HER2-positive breast cancer, and newer agents like fam-trastuzumab deruxtecan (T-DXd) and ado-trastuzumab emtansine (T-DM1). While these treatments focus on reducing tumor size and preventing cancer spread, Acellular Dermal Matrix (ADM) is used in the context of breast reconstruction post-mastectomy to provide structural support and potentially reduce complications such as infections and the need for additional surgeries.

What other types of research exist?

Promising novel alternatives to Acellular Dermal Matrix (ADM) for breast reconstruction in breast cancer patients may include the use of advanced biomaterials such as injectable soft tissue fillers (e.g., hyaluronic acid, calcium hydroxylapatite) and genetically modified skin grafts (e.g., those using viral vectors to deliver functional genes for tissue regeneration). Additionally, innovative surgical techniques like the use of pedicled flaps or negative pressure wound therapy could also be considered.

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Acellular Dermal Matrix in Breast Reconstruction Post-Cancer

Phase 3

Recruiting

Led By Evan Matros, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage

Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion

Must not have

Non-English speaking patients

Planning to undergo direct-to-implant reconstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying whether using a special material in breast reconstruction reduces problems like infections and the need for more surgeries. This material helps support new tissue growth. The goal is to see if patients have fewer issues after surgery when this material is used. This material has been increasingly used in breast reconstruction surgeries to support tissue growth and improve how the breast looks, though its impact on problems remains debated.

Who is the study for?

This trial is for women aged 21-60 who are planning nipple-sparing or skin-sparing mastectomies, either as a preventive measure or to treat breast cancer. They must be able to undergo immediate two-stage prosthetic breast reconstruction with tissue expander placement first. Women can't join if they've had chest radiation, currently smoke, don't speak English, or plan direct-to-implant reconstruction.

What is being tested?

The study compares the outcomes of prepectoral breast reconstruction using Acellular Dermal Matrix (ADM) versus without ADM. It focuses on immediate postoperative complications like infections and issues that might require additional surgery or removal of implants.

What are the potential side effects?

Potential side effects may include infection risks at the surgical site, possible reactions to the Acellular Dermal Matrix material used in some patients, and complications leading to further surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I plan to have a two-stage breast reconstruction with an initial tissue expander.

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The skin around my mastectomy area has good blood flow or can be treated by removing a small part.

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I plan to have a mastectomy that preserves the nipple or skin.

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My surgeon confirmed the area in front of my chest muscles is suitable for surgery.

Select...

I am a woman aged between 21 and 60.

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I am planning to have one or both breasts removed as a preventive measure or to treat breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not speak English.

Select...

I plan to have breast implants immediately after mastectomy.

Select...

I have had open-heart surgery before.

Select...

I have had radiation therapy on the breast where surgery was performed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients who experience major complications

Secondary study objectives

Estimate rates of minor complications (specifically seroma)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Prepectoral Breast Reconstruction without ADMExperimental Treatment1 Intervention

Group II: Prepectoral Breast Reconstruction with ADMExperimental Treatment1 Intervention

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments typically include surgery to remove the tumor, chemotherapy to kill cancer cells, radiation therapy to destroy remaining cancerous tissue, hormone therapy to block hormones that fuel certain cancers, and targeted therapy to attack specific cancer cell mechanisms. The use of Acellular Dermal Matrix (ADM) in breast reconstruction post-mastectomy provides a scaffold for tissue integration, potentially reducing complications such as infections and the need for additional surgeries. This is crucial for breast cancer patients as it can improve surgical outcomes, enhance recovery, and reduce the physical and emotional burden of multiple procedures.

Sarcoma of the breast: an update on a rare entity.