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New treatment option for Invasive Ductal Breast Carcinoma
Official title Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
ClinicalTrials.gov ID: NCT04084730
What this study is testing
- What it's testing
- The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.
- 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 45 and older, women only
You may be able to join if
- Female
- Age \>/= 45 years
- Unicentric pathological stage I (pT1 or T2 pN0\_M0) invasive ductal breast cancer or DCIS measuring \<3 cm in longest diameter on pathology and/or...
- Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen.
- ECOG Performance Status of 0 or 1.
You likely can't join if
- Patients with distant metastasis
- Patients who are pregnant or breastfeeding
- Patients with diffuse (\>1 quadrant or \>5cm) suspicious microcalcifications or patients with known multicentric OR multifocal disease. (microscopic...
- Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
- Histological evidence of extensive lymphovascular invasion (LVI)
- Histological evidence of extensive intraductal component (EIC), defined as the presence of intraductal carcinoma both within the primary infiltrating...
See the full eligibility criteria
- Female
- Age \>/= 45 years
- Unicentric pathological stage I (pT1 or T2 pN0\_M0) invasive ductal breast cancer or DCIS measuring \<3 cm in longest diameter on pathology and/or mammogram that is histologically confirmed. If T2, the tumor must be...
- Histologically negative tumor margin or no tumor in a re-excision specimen on final shaved specimen.
- ECOG Performance Status of 0 or 1.
- Negative serum pregnancy test within 14 days prior to study treatment if a woman has child-bearing potential. people of child bearing potential are those who have not been surgically sterilized or have not been free...
- Written informed consent obtained from subject and ability for subject or comply with the requirements of the study
- Female people of childbearing potential should be willing to use 2 methods or birth control or be surgically sterile or abstain from heterosexual activity for the duration of study participation. Should a woman become...
- Post-NAC cohort patients: clinical T1-T2 (less than or equal to 5cm in longest diameter on available imaging) and clinical N0-N1 (on exam and imaging) with pathological ypT0, ypTis, or ypT1 (\<=2cm) and ypN0 (any...
- Oncotype RS score of 26 or higher OR
- PAM50 ROR scored as "HIGH" OR
- Presence or LVI (focal, limited or "not otherwise specified") in the lumpectomy specimen OR
- Age 40-49 years (ALL OF THE FOLLOWING MUST BE TRUE : 1) no history of prior benign breast biopsies, 2) no concomitant or prior atypia in either breast, 3) no concomitant or prior LCIS in either breast, 4) no family...
- Invasive lobular carcinoma OR
- Surgical margins less than 1 mm to invasive or in-situ disease.
- Patients with distant metastasis
- Patients who are pregnant or breastfeeding
- Patients with diffuse (\>1 quadrant or \>5cm) suspicious microcalcifications or patients with known multicentric OR multifocal disease. (microscopic multifocal disease that may be unifocal and/or appear multifocal due...
- Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
- Histological evidence of extensive lymphovascular invasion (LVI)
- Histological evidence of extensive intraductal component (EIC), defined as the presence of intraductal carcinoma both within the primary infiltrating ductal tumor (comprising at least 25% of the tumo area) and...
- Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. Note: in the event a patient is tested and is found to be a mutation carrier, she would be excluded...
- History of cosmetic or reconstructive breast surgery.
- Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of...
- Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their...
- Patients who are already enrolled in or planning to enroll in other adjuvant systemic therapy protocols for both non-invasive or invasive breast cancer
- Expecting to conceive within the projected duration of the trials, starting with screening visit through 180 days after the last dose of trial treatment
- Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities...
- Ongoing therapy with other investigational agents. Patients may not be receiving any other investigational agents.
The study team makes the final eligibility decision.
Where it's taking place
- Norwalk, Connecticut, United States
- Miami, Florida, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, 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, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Norwalk, Connecticut, United States; Miami, Florida, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.