Radiation Therapy for Breast Cancer

Recruiting at 7 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Stage T3/T4, 4+ lymph nodes, Metastases, Prior breast cancer, Bilateral breast cancer, 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: 11

Duration: 3-5 weeks

301 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and have fewer side effects. It is not yet known if hypofractionated RT is more effective than standard RT in treating breast cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is radiation therapy for breast cancer safe for humans?

Research shows that hypofractionated radiation therapy (a type of radiation treatment given in fewer sessions) is generally safe for treating breast cancer, with similar safety and effectiveness as traditional radiation therapy. Studies have reported good local control of cancer and acceptable levels of side effects. ^{1 2 3 4 5}

How is hypofractionated radiation therapy different from other breast cancer treatments?

Hypofractionated radiation therapy for breast cancer is unique because it delivers radiation in larger doses over a shorter period, reducing the overall treatment time and cost compared to conventional radiation therapy. Studies have shown it to be as effective as traditional methods in controlling cancer and maintaining cosmetic outcomes, with ongoing research to further refine its use. ^{2 3 4 6 7}

What data supports the effectiveness of this treatment for breast cancer?

Research shows that hypofractionated radiation treatment (HFRT) is as effective and safe as traditional radiation treatment for early breast cancer, with potential benefits like fewer treatment sessions. Studies also indicate that HFRT is being increasingly adopted in real-world practice for breast cancer, despite some concerns about local control and toxicity. ^{1 2 6 8 9}

Research Team

Benjamin D. Smith, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients who've had breast-conserving surgery for ductal carcinoma in situ or early invasive breast cancer, with no tumor cells at the surgical margin. It's not open to those pregnant, with bilateral or advanced-stage breast cancer, more than 4 affected lymph nodes, metastases, previous breast cancers or radiation therapy in relevant areas.

Inclusion Criteria

My breast cancer is in the early stages and has not spread widely.

My last surgery showed no cancer at the edges of the tissue removed.

I had surgery to remove part of my breast.

Exclusion Criteria

My cancer has spread to distant parts of my body.

I have been diagnosed with breast cancer before.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either hypofractionated or conventionally fractionated whole breast irradiation

3-5 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes after treatment

5 years

Follow-up at 6 months, then annually

Treatment Details

Interventions

• Conventionally Fractionated Whole Breast Irradiation
• External Beam Radiation Therapy
• Hypofractionated Radiation Therapy
• Hypofractionated Whole Breast Irradiation
• Whole Breast Irradiation

Trial Overview The study compares two types of radiation therapy: hypofractionated (higher doses over a shorter period) and standard treatment. The goal is to see if the shorter-duration treatment is as effective while potentially causing fewer side effects.

Participant Groups

Group I: Arm I (HF-WBI) Experimental Treatment 6 Interventions

Patients undergo HF-WBI comprising external beam RT 5 days a week for approximately 3 weeks.

Group II: Arm II (CF-WBI) Active Control 5 Interventions

Patients undergo CF-WBI comprising external beam RT 5 days a week for approximately 5 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

In a study of 56 breast cancer patients receiving hypofractionated external beam radiotherapy (HFRT) after mastectomy, the treatment was well tolerated with mild to moderate acute skin toxicity, and no severe hematological toxicity was observed, indicating a favorable safety profile.

HFRT effectively delivered targeted doses to the chest wall while minimizing exposure to surrounding organs, with mean lung and heart doses remaining within safe limits, suggesting that HFRT can be a viable option for post-mastectomy radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer. Deshmukh, S., Sharan, K., Fernandes, DJ., et al.[2022]

In a study of 274 early breast cancer patients treated with hypofractionated radiation treatment (HFRT) over a median follow-up of 7 years, the local recurrence-free survival rate was very high at 97.2%, indicating that HFRT is effective in preventing local cancer recurrence.

The acute toxicity associated with HFRT was generally low, with most patients experiencing less than grade 3 side effects, suggesting that HFRT is a safe treatment option for eligible patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. James, ML., Dehn, G., Robinson, BA.[2018]

In a study of 1,010 breast cancer patients, hypofractionated radiotherapy (HFRT) showed similar locoregional recurrence-free survival (LRRFS) and disease-free survival (DFS) rates compared to conventionally fractionated radiotherapy (CFRT) after a median follow-up of 49.5 months.

While HFRT was effective across various nodal stages and molecular subtypes, it tended to show lower DFS in N2-3 patients with triple-negative breast cancer compared to CFRT, indicating a need for further investigation in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. Chen, F., Hui, TSK., Ma, L., et al.[2022]

In a study of 81 patients with localized breast cancer treated with hypofractionated radiotherapy (HFRT), the treatment was well-tolerated, with low rates of late toxicities such as chest pain (11%) and limb pain (12%).

The five-year overall survival rate was 76.5%, and there were no locoregional recurrences, indicating that HFRT is effective in controlling the disease while minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. Sindhu, M., Malik, M., Ahmed, SF., et al.[2022]

Hypofractionation for whole-breast irradiation is safe and effective, providing similar local control and cosmetic outcomes compared to traditional methods, as supported by recent randomized trials.

There is growing interest in using hypofractionation for partial-breast irradiation, with early studies showing promising local control and manageable side effects, while larger randomized trials are currently being conducted to further evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience using hypofractionated radiation schedules in breast cancer. Whelan, TJ., Kim, DH., Sussman, J.[2022]

Hypofractionated radiotherapy is gaining importance in breast cancer treatment, suggesting a shift towards more efficient radiation delivery methods.

The introduction of simultaneous integrated boost techniques allows for targeted treatment of the primary tumor region, potentially improving treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. Nitsche, M., Dunst, J., Carl, UM., et al.[2020]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Understanding variations in the use of hypofractionated radiotherapy and its specific indications for breast cancer: A mixed-methods study. [2018]

2. India pubmed.ncbi.nlm.nih.gov

A Study on Dosimetric Outcomes and Acute Toxicity of Post Mastectomy Adjuvant Hypofractionated Radiotherapy for Breast Cancer. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation treatment in early breast cancer: Results in a New Zealand setting. [2018]

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

Clinical Outcomes of Hypofractionated Whole Breast Irradiation in Early Stage, Biologically High-Risk Breast Cancer. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Real-World Practice of Hypofractionated Radiotherapy in Patients With Invasive Breast Cancer. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Assessment of toxicities and outcomes in patients with breast cancer treated with hypofractionated radiotherapy. [2022]

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

Clinical experience using hypofractionated radiation schedules in breast cancer. [2022]

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

Three-Year Outcomes With Hypofractionated Versus Conventionally Fractionated Whole-Breast Irradiation: Results of a Randomized, Noninferiority Clinical Trial. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Emerging Role of Hypofractionated Radiotherapy with Simultaneous Integrated Boost in Modern Radiotherapy of Breast Cancer. [2020]