Radiation Therapy for Breast Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if shorter, higher-dose radiation therapy is more effective and has fewer side effects than the standard approach for treating ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Participants will be randomly assigned to receive either hypofractionated radiation therapy (shorter duration) or conventional therapy (longer duration). Women aged 40 or older who have undergone breast-conserving surgery and do not have cancer spread to multiple lymph nodes may be eligible to participate.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that hypofractionated radiation therapy, which involves delivering higher doses of radiation over a shorter period, is generally safe for breast cancer patients. A review of several studies found that patients tolerated it well, with safety comparable to the usual method. One study found that many patients did not experience severe skin problems. Some had mild skin reactions, but these were not serious. Additionally, research indicates that lowering the total radiation dose can reduce the risk of long-term side effects. Overall, hypofractionated radiation therapy appears to be a well-tolerated option for treating breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiation therapy techniques for breast cancer because they promise greater convenience and potentially fewer side effects. Hypofractionated Whole Breast Irradiation (HF-WBI) differs from conventional methods by delivering higher doses of radiation over a shorter period, typically about 3 weeks, compared to the 5 weeks needed for Conventionally Fractionated Whole Breast Irradiation (CF-WBI). This shorter regimen could mean less disruption to patients' lives and possibly reduced long-term side effects, making it an attractive alternative to traditional treatment schedules.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Studies have shown that hypofractionated radiation therapy (HF-WBI), a shorter type of radiation therapy, is as effective as the standard treatment for breast cancer. In this trial, participants in Arm I will receive HF-WBI, which involves external beam radiation therapy 5 days a week for approximately 3 weeks. Participants in Arm II will receive conventionally fractionated whole breast irradiation (CF-WBI), involving external beam radiation therapy 5 days a week for approximately 5 weeks. Research indicates that after 10 years, the breast's appearance remains similar whether patients undergo the shorter or standard treatment. One study found that a one-week course of HF-WBI is as effective and safe as the longer, traditional schedule. This suggests that HF-WBI can be a good option, offering the same effectiveness with potentially fewer side effects due to the shorter treatment time. ^{2 4 6 7 8}

Who Is on the Research Team?

Benjamin D. Smith, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa0906260

Long-Term Results of Hypofractionated Radiation Therapy ... At 10 years, 71.3% of women in the control group as compared with 69.8% of the women in the hypofractionated-radiation group had a good or excellent cosmetic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3346174/

Are Three Weeks of Whole-Breast Radiotherapy as Good ... At 10 years, 71.3% of women in the control group as compared with 69.8% of the women in the hypofractionated-radiation group had a good or excellent cosmetic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625006526

Once-Weekly Ultra-Hypofractionated Radiation Therapy for ... This study reports outcomes of once-weekly adjuvant whole-breast radiotherapy in elderly and/or comorbid patients with breast cancer, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8934112/

Has Hypofractionated Whole Breast Radiation Therapy ... After the guidelines were published, an analysis of National Cancer Database (NCDB) data reported that the usage of HF-WBI reached 15.6% among invasive cancer ...

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(20)30932-6/fulltext

Hypofractionated breast radiotherapy for 1 week versus 3 ... FAST-Forward results confirm that 26 Gy in five fractions is as effective and safe as an international standard 15-fraction regimen after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10845660/

Efficacy and safety analysis of hypofractionated and ... In this meta-analysis, we conducted a comparative analysis of the safety and efficacy of hypofractionated and conventional fractionated ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820925002344

Real World Safety of Adjuvant Ultra Hypofractionated ... Ultra-hypofractionated breast radiotherapy (26 Gy in 5 fractions) was well tolerated. · More than half of patients showed no skin toxicity; grade ...

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2118572

Hypofractionated Whole Breast Radiotherapy: Adapting to ... In the recent trials of hypofractionated breast radiotherapy, the total dose was reduced to mitigate the risk of late toxic effects (as observed ...