Radiation Therapy for Breast Cancer

(FAST NOVEMBER Trial)

Overseen By Rachel Kingsford

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Utah

Must not be taking: Radiation sensitizing medications

Disqualifiers: Bilateral breast cancer, prior chemotherapy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

144 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take medications that make radiation more effective during the study.

What data supports the effectiveness of the treatment Whole Breast Radiotherapy for breast cancer?

Research shows that whole breast radiotherapy after breast-conserving surgery reduces the chance of cancer coming back and lowers the risk of death. It is considered a standard treatment for early breast cancer and has been shown to improve survival rates, especially in high-risk patients. ^{1 2 3 4 5}

Is radiation therapy for breast cancer generally safe for humans?

Radiation therapy for breast cancer, including whole-breast radiotherapy, is generally safe when proper techniques are used, though some patients may experience skin reactions or other side effects. Accelerated partial breast irradiation with brachytherapy has a very low risk profile and fewer late side effects compared to whole-breast irradiation. ^{6 7 8 9 10}

How is whole breast radiotherapy different from other breast cancer treatments?

Whole breast radiotherapy (WBRT) is unique because it targets the entire breast, reducing the risk of cancer returning in the breast area after breast-conserving surgery. It is often used as a standard treatment to prevent recurrence and can be delivered in a shorter, hypofractionated schedule, which means fewer sessions with a higher dose per session, compared to traditional longer schedules. ^{1 4 11 12 13}

What is the purpose of this trial?

The goal of this study is to evaluate 5 days vs. 9 days of whole breast radiation.

Research Team

Matthew R. Poppe, MD

Principal Investigator

Huntsman Cancer Institute

Eligibility Criteria

This trial is for women aged 18 or older with early-stage breast cancer who've had a lumpectomy. They must not be pregnant, agree to use contraception if of childbearing potential, and have an ECOG Performance Status ≤ 2 or KPS ≥ 50. Women over 50 need additional risk factors like aggressive tumor grade or low estrogen receptor positivity.

Inclusion Criteria

I am a woman aged 18 or older.

Negative pregnancy test for participants of childbearing potential, evidence of permanent surgical sterilization, or post-menopausal status

Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria

Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study

I am currently on medication or therapy to enhance the effects of radiation.

My condition makes me more sensitive to radiation treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive either 5 or 9 fractions of whole breast radiotherapy

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Long-term follow-up

Participants are monitored for long-term radiation-related adverse events and recurrence rates

5-8 years

Treatment Details

Interventions

• Whole Breast Radiotherapy

Trial Overview The study compares two durations of whole breast radiation therapy: a short course of five days versus a longer nine-day treatment in patients with early-stage breast cancer following lumpectomy surgery.

Participant Groups

Group I: 5 fractions of radiotherapy (Arm 1) Experimental Treatment 1 Intervention

Group II: 9 fractions of radio therapy (Arm 2) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Findings from Research

Radiation therapy is an effective treatment for both ductal carcinoma in situ (DCIS) and invasive breast cancer, with lumpectomy followed by radiation being particularly effective for DCIS.

Shorter radiation schedules are just as effective as traditional longer regimens for early breast cancer, and postmastectomy radiation provides survival benefits for high-risk premenopausal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation treatment for breast cancer. Recent advances. Chow, E.[2018]

Radiation therapy is an effective and safe option for breast conservation therapy in localized breast cancer, with careful consideration of factors like patient history and breast size.

Acute skin reactions during treatment do not predict long-term complications, suggesting that with proper techniques, most patients can achieve good outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservation Therapy of the Breast: Optimizing Long-term Results. Greenberg, HM.[2019]

In a study of 703 Japanese women who underwent breast-conserving surgery and radiation therapy, common late adverse events included breast pain, fibrosis, and pneumonitis, with serious complications (Grade 2 or 3) occurring in only 3.8% of patients.

The cosmetic outcomes were favorable, with 69.1% of patients reporting excellent or good results, indicating that the treatment is effective not only in managing cancer but also in preserving breast appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy. Nozaki, M., Kagami, Y., Mitsumori, M., et al.[2022]

Implementing a radiation dermatitis (RD) prevention protocol significantly improved oncology nurses' confidence in assessing and managing RD in breast cancer patients, as shown by surveys completed by 11 nurses before and after an education session.

The protocol led to a statistically significant increase in the use of topical steroids for RD prophylaxis, which is expected to help reduce the incidence of dermatologic adverse events during radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Dermatitis: A Prevention Protocol for Patients With Breast Cancer. Lucas, AS., Lacouture, M., Schneider, SM.[2019]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Intraoperative breast radiotherapy: survival, local control and risk factors for recurrence. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Radiation treatment for breast cancer. Recent advances. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

The role of radiation therapy for primary breast cancer. [2019]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Results of intraoperative radiotherapy given as a boost after breast conserving-surgery. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A randomised study of whole-breast vs tumour-bed irradiation after local excision and axillary dissection for early breast cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Conservation Therapy of the Breast: Optimizing Long-term Results. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Breast brachytherapy. [2021]

8. England pubmed.ncbi.nlm.nih.gov

A multicenter investigation of late adverse events in Japanese women treated with breast-conserving surgery plus conventional fractionated whole-breast radiation therapy. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Predictors of Acute Radiation Dermatitis and Esophagitis in African American Patients Receiving Whole-Breast Radiation Therapy. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Radiation Dermatitis: A Prevention Protocol for Patients With Breast Cancer. [2019]

11. Ireland pubmed.ncbi.nlm.nih.gov

Ipsilateral axillary recurrence after breast conservative surgery: The protective effect of whole breast radiotherapy. [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Are Three Weeks of Whole-Breast Radiotherapy as Good as Five Weeks in Early Breast Cancer? - 10 Year Follow-Up in the Canadian Trial of Hypofractionated Radiation Therapy. [2021]

13. Ireland pubmed.ncbi.nlm.nih.gov

Whole breast radiotherapy in the lateral isocentric lateral decubitus position: Long-term efficacy and toxicity results. [2022]