Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested With a Non-inferiority Assessment of APBI in New Patient Cohorts

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Accelerated Partial Breast Irradiation
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 45
Healthy Volunteers: f
View:

• 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 less than 3cm in longest diameter. Note: Women ≥ 70 years or older with T1 invasive ductal carcinoma who are estrogen- receptor positive (ER+) with clinically negative axillary nodes, and do not undergo surgical lymph node mapping or dissection (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is detected by immunohistochemistry or hematoxylin and eosin staining) will also be eligible. Patients age 50 or older who are clinically node-negative by physical exam and ultrasound and have a primary tumor that is \<=2 cm and hormone-receptor positive, are also eligible.

• 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. Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year

• Written informed consent obtained from subject and ability for subject or comply with the requirements of the study

• Female subjects 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 pregnant while participating on study, she should inform the treating physician immediately.

• 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 regimen of neoadjuvant chemotherapy agents is allowed)

⁃ OR

• 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 history of breast cancer in first degree relatives)

⁃ OR

• Invasive lobular carcinoma

⁃ OR

• Surgical margins less than 1 mm to invasive or in-situ disease.

Locations
United States
Connecticut
Norwalk Hospital
RECRUITING
Norwalk
Florida
Baptist Alliance Miami Cancer Institute
RECRUITING
Miami
New Jersey
Memorial Sloan Kettering Basking Ridge
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth
RECRUITING
Middletown
Memorial Sloan Kettering Bergen
RECRUITING
Montvale
New York
Memorial Sloan Kettering Commack
RECRUITING
Commack
Memorial Sloan Kettering Westchester
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau
RECRUITING
Uniondale
Contact Information
Primary
Atif J Khan, MD
khana7@mskcc.org
848-225-6334
Backup
Simon Powell, MD, PhD
powells@mskcc.org
212-639-3639
Time Frame
Start Date: 2019-08-30
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 280
Treatments
Experimental: Participants with Breast Cancer
Participants will have unicentric pathological stage I invasive ductal breast cancer or Grade 1 or 2 DCIS measuring \<3cm in longest diameter on pathology and/or mammogram that is histologically confirmed at MSKCC.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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