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New treatment option for Breast Cancer
Official title EMERALD: Endocrine Therapy oMission With Radiation in ER+ Breast Cancer: Assessing Quality of Life and Disease Control: a Prospective Phase II Trial
ClinicalTrials.gov ID: NCT06897488
What this study is testing
- What it's testing
- This clinical research study is to learn about the effects of giving radiotherapy alone after lumpectomy to patients who have early-stage, low-risk breast cancers and who are 60 years of age or older.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, women only
You may be able to join if
- Diagnosis of pathologically-confirmed invasive breast cancer
- Age ≥ 60 years
- Treatment with breast conserving surgery
- Pathologic T stage of T1 or T2 with total tumor size ≤ 3cm including any component of DCIS that may exist in conjunction with invasive disease
- Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low)
You likely can't join if
- Node positive disease (N1-3)
- Metastatic disease (M1)
- Grade 3 disease and lymphovascular space invasion in the tumor
- Synchronous bilateral breast cancer
- Receipt of neoadjuvant therapy
- Diagnosis of a collagen vascular disease associated with an increased incidence of radiation toxicities such as scleroderma or systemic lupus...
See the full eligibility criteria
- Diagnosis of pathologically-confirmed invasive breast cancer
- Age ≥ 60 years
- Treatment with breast conserving surgery
- Pathologic T stage of T1 or T2 with total tumor size ≤ 3cm including any component of DCIS that may exist in conjunction with invasive disease
- Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low)
- Final surgical margins negative, defined as no tumor on ink. Lobular carcinoma in situ involving the final surgical margin will be disregarded.
- Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neu non-amplified as per current College of American Pathologists guidelines
- Clinical nodal stage cN0
- If pathologic nodal staging is obtained, then pN0 or pN0(i+)
- Patients have had or have a scheduled discussion with a breast medical oncologist regarding adjuvant treatment options
- Patients who have met criteria 4.1.1-4.1.9 who never initiate endocrine therapy OR who initiate adjuvant endocrine therapy but discontinue it within 6 months of initiation \ In some clinical scenarios, patients may have...
- Node positive disease (N1-3)
- Metastatic disease (M1)
- Grade 3 disease and lymphovascular space invasion in the tumor
- Synchronous bilateral breast cancer
- Receipt of neoadjuvant therapy
- Diagnosis of a collagen vascular disease associated with an increased incidence of radiation toxicities such as scleroderma or systemic lupus erythematosis
- Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cell carcinoma of the skin that has been treated
- Patient with psychiatric illness/social situations that would limit compliance with study requirements
- Prior radiotherapy to the index breast or recurrent cancer of the breast
- Known carrier of a mutation associated with predisposition to breast cancer development, including BRCA1 or BRCA2
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.