Radiation Therapy for Breast Cancer

Overseen By Cancer Connect

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Mastectomy, Metastatic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 5 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to radiation therapy for women with early-stage breast cancer. It focuses on ultra-short whole breast irradiation, specifically Whole Breast Irradiation with Simultaneous Integrated Boost, which aims to reduce side effects while effectively targeting cancer. Researchers aim to understand how this treatment impacts cosmetic outcomes, patient-reported experiences, and any side effects. Women who have had breast-conserving surgery, with early-stage breast cancer and no spread to lymph nodes, may be eligible to participate. The study will monitor participants for up to 60 months to gather comprehensive results. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve future breast cancer treatments.

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 prior data suggests that this radiation therapy technique is safe for breast cancer patients?

Research has shown that whole breast irradiation with simultaneous integrated boost (SIB) is generally safe for patients with early-stage breast cancer. Studies have found that this treatment does not cause more early side effects than expected, with most patients experiencing typical side effects.

One study tested a similar treatment and found it both feasible and safe, indicating that patients can handle it well. Another study demonstrated that using SIB can reduce the treatment duration from several weeks to just a few weeks, enhancing convenience and comfort for patients.

Overall, evidence suggests that this treatment is safe and manageable for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for breast cancer, like standard whole breast irradiation, target the entire breast at once. However, the "Whole Breast Irradiation with Simultaneous Integrated Boost" is unique because it delivers a higher dose of radiation directly to the tumor site while simultaneously treating the surrounding breast tissue. This targeted approach could potentially reduce side effects and improve tumor control compared to traditional methods. Researchers are excited because this method might offer a more efficient way to target cancer cells, enhancing treatment effectiveness and patient outcomes.

What evidence suggests that whole breast irradiation with simultaneous integrated boost is effective for breast cancer?

Research has shown that whole breast irradiation (WBI) with simultaneous integrated boost (SIB) effectively treats breast cancer. This trial will evaluate WBI with SIB, which delivers higher radiation doses directly to the tumor, potentially shortening the overall treatment time. Typically, radiation treatments last 4–6 weeks, but SIB can reduce this to just 3 weeks. Early results suggest that this method matches the effectiveness of traditional radiation and improves patient comfort by reducing therapy length. Additionally, a major study with 5-year results strongly supported that SIB effectively targets the tumor while protecting healthy tissue. ^{1 4 5 6 7}

Who Is on the Research Team?

Jessica Schuster, MD

Principal Investigator

UW Carbone Cancer Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: WBI with SIB Experimental Treatment 1 Intervention

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

Approved in United States as Whole Breast Irradiation with Simultaneous Integrated Boost for:

• Early-stage breast cancer

Approved in European Union as Whole Breast Irradiation with Simultaneous Integrated Boost for:

• Early-stage breast cancer

Approved in Canada as Whole Breast Irradiation with Simultaneous Integrated Boost for:

• Early-stage breast cancer

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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., Köder, C., Häfner, MF., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 of 93 elderly breast cancer patients treated with intensity-modulated radiation therapy (IMRT) using a simultaneous integrated boost (SIB) technique, the 5-year overall survival rate was an impressive 96.3%, indicating high efficacy of this treatment approach.

The treatment was found to be safe, with most patients experiencing only mild acute side effects, such as grade 1 dermatitis in 81.7% of cases, and a low incidence of more severe complications like grade 2 dermatitis (18.3%) and grade 1 pneumonitis (4.3%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant whole breast radiotherapy with simultaneous integrated boost to tumor bed with intensity modulated radiotherapy technique in elderly breast cancer patients. Chen, KW., Hsu, HT., Lin, JF., et al.[2022]

Using intensity-modulated radiation therapy (IMRT) with a simultaneous integrated boost (SIB) can reduce breast cancer treatment time from 7 weeks to 5 weeks while maintaining effective dosing, as shown in treatment plans for two patients with different tumor depths.

The new IMRT SIB regimen is biologically equivalent to traditional treatment methods and offers better dosimetric outcomes, such as reduced exposure of healthy breast tissue to high radiation doses, making it a promising option for selected breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous integrated boost for breast cancer using IMRT: a radiobiological and treatment planning study. Guerrero, M., Li, XA., Earl, MA., et al.[2022]

In a study of 167 patients receiving breast cancer treatment, the simultaneous integrated boost (SIB) method did not show a significant difference in the occurrence of moist desquamation compared to the sequential boost (SeB) method, indicating similar safety profiles for both approaches.

However, patients in the SeB arm experienced significantly more grade 2/3 dermatitis (38% vs 29%) and higher rates of pruritus (61% vs 43%), suggesting that SIB may lead to fewer side effects in terms of skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an integrated boost increase acute toxicity in prone hypofractionated breast irradiation? A randomized controlled trial. Paelinck, L., Gulyban, A., Lakosi, F., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 of 467 early-stage breast cancer patients treated with adjuvant IMRT-SIB after breast-conserving surgery, the 5-year rates of locoregional control and distant metastasis-free survival were both 98.7%, indicating excellent long-term tumor control.

The treatment resulted in low levels of acute skin toxicity, with 76.5% of patients experiencing grade 0-1 toxicity, and 86.5% reported good or excellent cosmetic outcomes at the 12-month follow-up, suggesting that IMRT-SIB is a safe and effective option for breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant breast inversely planned intensity-modulated radiotherapy with simultaneous integrated boost for early stage breast cancer : Results from a phase II trial. Meng, J., Huang, W., Mei, X., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6069338/

Breast-conserving radiotherapy with simultaneous ... To examine the feasibility of improving breast-conserving radiotherapy with simultaneous integrated boost (SIB) and analyzing the efficiency of forward ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06902311

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation ... This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)00619-0/fulltext

Dose-escalated simultaneous integrated boost ... Breast boost radiotherapy usually consists of 4–6 weeks of treatment, so a reduction to just 3 weeks of SIB would be beneficial for both ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8798908/

Adjuvant whole breast radiotherapy with simultaneous ... IMRT with simultaneous integrated boost (SIB) technique can deliver higher doses to tumor bed and irradiate whole breast with a lower dose level to shorten ...

5. redjournal.org redjournal.org/article/S0360-3016(23)00523-0/fulltext

5-Year Results of the IMRT-MC2 Phase III Trial The 5-year results of the IMRT-MC2 trial provide strong evidence that the application of conventionally fractionated simultaneous integrated ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625001415

Ultrahypofractionation and Simultaneous Integrated Boost ... UHF with SIB of 29 Gy to the tumor bed in patients with early-stage breast cancer is clinically feasible, safe, and free of an excess of early side effects.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07020780

5 fr Ultrahypofractionated WBI and SIB for Breast Cancer ... Patients in the study (randomized to arm 1) will be treated to the whole breast to a total dose (TD) of 26 Gy in 5 fractions, with simultaneous integrated boost ...