Accelerated Partial Breast Irradiation for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Frederick M. Dirbas

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?

To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.

Research Team

Frederick M. Dirbas

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for women aged 40 or older with invasive ductal carcinoma or ductal carcinoma in situ, choosing lumpectomy over mastectomy. The tumor must be smaller than 2.5 cm with a clear margin of normal tissue around it. It's not for those who are immunocompromised, pregnant, have poorly controlled diabetes, previous malignancies with less than five years survival expectation, certain breast implants, or contraindications to radiotherapy.

Inclusion Criteria

I have chosen lumpectomy over mastectomy for my breast cancer treatment.

My tumor is smaller than 2.5 cm with a clear margin of normal tissue around it.

I am a woman over 40 with a type of breast cancer.

Exclusion Criteria

My cancer was found in lymph nodes during my lumpectomy.

It has been over 12 weeks since my last surgery or chemotherapy.

I have breast implants placed before any cancer treatment.

Treatment Details

Interventions

• Accelerated External Beam 3-D Conformal Radiotherapy (Radiation Therapy)
• Intracavitary Brachytherapy (Radiation Therapy)
• IORT (Radiation Therapy)
• Stereotactic APBI (Radiation Therapy)
• Whole Breast Radiotherapy (Radiation Therapy)

Trial Overview The study tests if accelerated radiotherapy after lumpectomy is as safe and effective as the standard six-week course. Methods include IORT as a single dose; intracavitary brachytherapy over five days; partial breast 3-D CRT in five days; or stereotactic APBI across four days. Outcomes like treatment complications, cosmetic results, cancer recurrence rates and overall survival will be measured.

Participant Groups

Group I: Accelerated Partial Breast Irradiation Experimental Treatment 5 Interventions

lumpectomy with accelerated partial breast irradiation

Group II: Standard Therapy Active Control 2 Interventions

lumpectomy and whole breast irradiation

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD