No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for
This trial is looking for women aged 60 and older who have low-risk, early-stage breast cancer that has been surgically treated. Participants will receive radiotherapy to understand its effects on life quality and disease control.
Are You a Good Fit for This Trial?
Rules you outCollagen vascular diseaseMetastatic breast cancer
You may be able to join if
I have been diagnosed with invasive breast cancer.
I am 60 years of age or older.
I have had breast conserving surgery.
My tumor is 3 cm or smaller.
I have not started endocrine therapy or stopped it within 6 months.
My tumor is estrogen receptor positive and progesterone receptor positive.
You may not be able to join if
I have node positive disease.
I have metastatic disease.
I have been diagnosed with Grade 3 breast cancer.
I have simultaneous breast cancer in both breasts.
I have received neoadjuvant therapy.
I have a connective tissue disease that increases radiation risk.
I have been diagnosed with another cancer in the past 5 years.
I have a psychiatric illness that affects my ability to comply with the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of pathologically-confirmed invasive breast cancer
2. Age ≥ 60 years
3. Treatment with breast conserving surgery
4. 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
5. Ki-6…
Inclusion Criteria:
1. Diagnosis of pathologically-confirmed invasive breast cancer
2. Age ≥ 60 years
3. Treatment with breast conserving surgery
4. 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
5. Ki-67 . 20% and/or Oncotype 0-10 (Ultra Low)
6. Final surgical margins negative, defined as no tumor on ink. Lobular carcinoma in situ involving the final surgical margin will be disregarded.
7. Tumor must be estrogen receptor positive, progesterone receptor positive and HER2Neu non-amplified as per current College of American Pathologists guidelines
8. Clinical nodal stage cN0
9. If pathologic nodal staging is obtained, then pN0 or pN0(i+)
10. Patients have had or have a scheduled discussion with a breast medical oncologist regarding adjuvant treatment options
11. 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 a particularly small volume of tumor, making it not be feasible for all of these biomarkers to be evaluated. In this scenario, if the PI and/or Protocol Collaborators are able to document that a patient is being treated as if they have luminal A (biologically favorable) breast cancer then the patient is eligible for enrollment if all other eligibility criteria are met.
Exclusion Criteria:
1. Node positive disease (N1-3)
2. Metastatic disease (M1)
3. Grade 3 disease and lymphovascular space invasion in the tumor
4. Synchronous bilateral breast cancer
5. Receipt of neoadjuvant therapy
6. Diagnosis of a collagen vascular disease associated with an increased incidence of radiation toxicities such as scleroderma or systemic lupus erythematosis
7. Diagnosis of other cancer within the prior 5 years, excluding basal or squamous cell carcinoma of the skin that has been treated
8. Patient with psychiatric illness/social situations that would limit compliance with study requirements
9. Prior radiotherapy to the index breast or recurrent cancer of the breast
10. Known carrier of a mutation associated with predisposition to breast cancer development, including BRCA1 or BRCA2
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