50 Participants Needed

Radiation Therapy for Breast Cancer

CC
Overseen ByCancer Connect
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you are undergoing concurrent cytotoxic chemotherapy.

What data supports the effectiveness of the treatment Whole Breast Irradiation with Simultaneous Integrated Boost for breast cancer?

Research shows that using intensity-modulated radiation therapy (IMRT) with a simultaneous integrated boost (SIB) can improve dose distribution and reduce treatment time for breast cancer patients. Studies also suggest that this approach may reduce acute side effects compared to traditional methods.12345

Is radiation therapy with simultaneous integrated boost safe for breast cancer patients?

Research shows that intensity-modulated radiation therapy (IMRT) with simultaneous integrated boost (SIB) is generally safe for breast cancer patients, with reduced acute toxicities (short-term side effects) compared to traditional methods. Long-term studies also support its safety, especially in elderly patients.12346

How is the treatment Whole Breast Irradiation with Simultaneous Integrated Boost different from other breast cancer treatments?

This treatment is unique because it uses intensity-modulated radiation therapy (IMRT) to deliver a higher dose of radiation directly to the tumor area while simultaneously treating the whole breast, which can shorten the overall treatment time and reduce side effects compared to traditional methods.12347

What is the purpose of this trial?

This study is being done to evaluate cosmetic, patient-reported outcome measures (PROMs), and toxicities for women undergoing ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB). 50 participants will be on study for up to 60 months.

Research Team

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Jessica Schuster, MD

Principal Investigator

UW Carbone Cancer Center

Eligibility Criteria

This trial is for women with breast cancer who are eligible for radiation therapy. Specific eligibility details aren't provided, but typically participants must be in good health aside from their cancer and meet certain medical criteria.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document
Willingness to comply with all study procedures and be available for the duration of the study
My treatment plan includes breast-saving surgery followed by radiation.
See 3 more

Exclusion Criteria

I have had breast cancer in the same breast before.
I have not had cancer in the last 5 years, except for skin cancer.
My cancer has spread to the lymph nodes or other areas.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ultra-short whole breast irradiation (WBI) therapy with simultaneous integrated boost (SIB) over 5 treatment visits

5 weeks
5 treatment visits

Follow-up

Participants are monitored for cosmetic outcomes, patient-reported outcomes, and toxicities at multiple intervals post-treatment

60 months
7 study visits at 6 weeks, 12, 24, 36, 48, and 60 months

Treatment Details

Interventions

  • Whole Breast Irradiation with Simultaneous Integrated Boost
Trial Overview The study tests a new approach to radiation therapy called ultra-short whole breast irradiation (WBI) with simultaneous integrated boost (SIB). It aims to evaluate the cosmetic outcomes, patient satisfaction, and any side effects over a period of up to 5 years.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: WBI with SIBExperimental Treatment1 Intervention

Whole Breast Irradiation with Simultaneous Integrated Boost is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Whole Breast Irradiation with Simultaneous Integrated Boost for:
  • Early-stage breast cancer
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Approved in European Union as Whole Breast Irradiation with Simultaneous Integrated Boost for:
  • Early-stage breast cancer
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Approved in Canada as Whole Breast Irradiation with Simultaneous Integrated Boost for:
  • Early-stage breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Findings from Research

In a study of 354 breast cancer patients treated with simultaneous integrated boost intensity-modulated radiation therapy (SIB-IMRT), the treatment showed a high 3-year overall survival rate of 97.6% for invasive breast cancer and 98% for ductal carcinoma in situ, with low rates of locoregional recurrence (2.8% and 1.4%, respectively).
SIB-IMRT demonstrated a favorable safety profile, with 57% of patients experiencing Grade 1 acute toxicity and only <1% experiencing Grade 3 toxicity, while also achieving good or excellent cosmetic outcomes in 96.5% of cases assessed after a minimum of 3 years.
Three-year outcomes of breast intensity-modulated radiation therapy with simultaneous integrated boost.McDonald, MW., Godette, KD., Whitaker, DJ., et al.[2022]
In a study involving 10 patients with early-stage left-sided breast cancer, intensity-modulated radiation therapy (IMRT) provided better target volume coverage compared to IMRT plus electron boost (IMRT-EB) and volumetric-modulated arc therapy (VMAT).
However, VMAT resulted in higher radiation doses to the heart and lungs, suggesting that while it may improve target coverage, it could pose greater risks to these organs compared to IMRT.
Dosimetric comparison of the simultaneous integrated boost in whole-breast irradiation after breast-conserving surgery: IMRT, IMRT plus an electron boost and VMAT.Wu, S., Lai, Y., He, Z., et al.[2020]
In a study involving 502 breast cancer patients, both intensity-modulated radiotherapy (IMRT) with simultaneous-integrated boost (SIB) and 3D-conformal radiotherapy were found to be well tolerated, with no significant difference in overall radiation dermatitis between the two treatment methods.
However, patients receiving IMRT with SIB experienced a higher rate of severe radiation dermatitis (grade 2/3) compared to those receiving 3D-conformal therapy, while breast pain was more common in the 3D-conformal group, indicating different side effect profiles for the two approaches.
Acute toxicity of normofractionated intensity modulated radiotherapy with simultaneous integrated boost compared to three-dimensional conformal radiotherapy with sequential boost in the adjuvant treatment of breast cancer.Krug, D., KΓΆder, C., HΓ€fner, MF., et al.[2021]

References

Three-year outcomes of breast intensity-modulated radiation therapy with simultaneous integrated boost. [2022]
Dosimetric comparison of the simultaneous integrated boost in whole-breast irradiation after breast-conserving surgery: IMRT, IMRT plus an electron boost and VMAT. [2020]
Acute toxicity of normofractionated intensity modulated radiotherapy with simultaneous integrated boost compared to three-dimensional conformal radiotherapy with sequential boost in the adjuvant treatment of breast cancer. [2021]
Adjuvant whole breast radiotherapy with simultaneous integrated boost to tumor bed with intensity modulated radiotherapy technique in elderly breast cancer patients. [2022]
Does an integrated boost increase acute toxicity in prone hypofractionated breast irradiation? A randomized controlled trial. [2018]
Adjuvant breast inversely planned intensity-modulated radiotherapy with simultaneous integrated boost for early stage breast cancer : Results from a phase II trial. [2020]
Simultaneous integrated boost for breast cancer using IMRT: a radiobiological and treatment planning study. [2022]
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