What is the mechanism of action of this treatment?

Breast cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery, including biopsies, physically removes cancerous tissue, which is crucial for diagnosis and reducing tumor burden. Radiation therapy uses high-energy rays to destroy cancer cells and shrink tumors. Chemotherapy involves drugs that kill rapidly dividing cells, including cancer cells, throughout the body. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers, while targeted therapy focuses on specific molecular targets, such as HER2, to inhibit cancer growth. These treatments are essential for managing breast cancer, improving survival rates, and tailoring therapy to individual patient needs based on diagnostic findings from procedures like biopsies.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, including surgery (mastectomy, lumpectomy), radiation therapy, chemotherapy, and endocrine therapy, are associated with various side effects. Surgery can lead to pain, lymphedema, and scarring. Radiation therapy often causes skin irritation, fatigue, and changes in breast tissue. Chemotherapy is known for causing nausea, hair loss, fatigue, and increased risk of infections. Endocrine therapy, such as tamoxifen or aromatase inhibitors, can result in hot flashes, bone density loss, and joint pain. These side effects can vary in intensity and duration, impacting the patient's quality of life.

What prior FDA approvals exist?

FDA-approved treatments for breast cancer include targeted therapies such as trastuzumab, which is used for HER2-positive breast cancer. Trastuzumab has been approved for use in both early-stage and metastatic settings, often in combination with chemotherapy. Additionally, hormone receptor-positive breast cancers may be treated with hormone therapies like tamoxifen or aromatase inhibitors. Biopsies play a crucial role in diagnosing breast cancer and determining the appropriate treatment by analyzing biomarkers such as hormone receptors and HER2 status.

What other types of research exist?

Promising novel alternatives to traditional breast biopsy for breast cancer patients include: 1) Sentinel lymph node biopsy, which is less invasive and used for staging the axilla. 2) Needle microendoscopy, which offers real-time microscopic evaluation. 3) Ultrasound-guided Tru-cut biopsy, which is a minimally invasive method using a spring-loaded needle. 4) Vacuum-assisted biopsy (VB) with digital stereotactic Mammotome, which uses vacuum suction for tissue sampling and is less invasive than surgical biopsy.

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Patient-Reported Outcomes After Breast Biopsy

N/A

Waitlist Available

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Patients treated at DUMC, DFCI, MDACC, MGH, NWH, or DFCI @ SSH with a diagnosis of DCIS, LCIS, ADH, or ALH

Age 18 or more at index diagnosis

Must not have

Ever had a diagnosis of invasive or microinvasive breast cancer

DCIS prior to index lesion or history of progressive/recurrent DCIS after treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patient reported outcome was scheduled from at least one year from diagnosis. participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort.

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how women feel after a breast biopsy, focusing on those with certain breast conditions. The goal is to help women and doctors make better care decisions based on these experiences.

Who is the study for?

This trial is for adults who've had a breast biopsy showing atypical lesions and have been treated at certain study sites. They must be able to read English or Spanish, provide consent, and have at least one year of follow-up data post-diagnosis. Those with other cancers within the last five years or invasive breast cancer ever are excluded.

What is being tested?

The PORTAL study is not testing a drug but rather collecting information through surveys on how patients feel physically and emotionally after treatment for specific non-invasive breast conditions like ADH, ALH, LCIS, or DCIS.

What are the potential side effects?

Since this trial involves completing surveys about patient experiences post-treatment rather than testing medications or therapies, there are no direct side effects associated with the interventions being studied.

Eligibility Criteria

Inclusion Criteria

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

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I was treated for early breast changes at a specified hospital.

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I was 18 or older when my condition was first diagnosed.

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I have had breast conditions in both breasts, either at the same time or at different times.

Exclusion Criteria

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

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I have been diagnosed with invasive or microinvasive breast cancer before.

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I have had DCIS before my current cancer or it came back after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patient reported outcome was scheduled from at least one year from diagnosis. participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patient reported outcome was scheduled from at least one year from diagnosis. participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort.

This trial's timeline: 3 weeks for screening, Varies for treatment, and patient reported outcome was scheduled from at least one year from diagnosis. participants' time from diagnosis to completing a survey was an average of 45.8 months in this study cohort. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The Measures Severity of Chronic Pain.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patient-reported Outcomes SurveyExperimental Treatment1 Intervention

The survey will administered online, over the phone, or via mail.

0 / 5Eligibility 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 work through various mechanisms to target and eliminate cancer cells. Surgery, including biopsies, physically removes cancerous tissue, which is crucial for diagnosis and reducing tumor burden. Radiation therapy uses high-energy rays to destroy cancer cells and shrink tumors. Chemotherapy involves drugs that kill rapidly dividing cells, including cancer cells, throughout the body. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers, while targeted therapy focuses on specific molecular targets, such as HER2, to inhibit cancer growth. These treatments are essential for managing breast cancer, improving survival rates, and tailoring therapy to individual patient needs based on diagnostic findings from procedures like biopsies.