Radiation Therapy Schedules for Breast Cancer

Not currently recruiting at 14 trial locations

Overseen By Karen Hoffman, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Metastases, Contralateral cancer, Pregnancy, 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: 8

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 breast cancer recurs more frequently when hypofractionated radiation therapy (a type of radiation treatment given over a shorter period) is administered over 3 weeks instead of 5 weeks. It also examines potential side effects during or after treatment, such as arm swelling. Participants will receive radiation to the lymph nodes near the breast, with two different treatment timelines being tested. This trial may suit those advised by their doctor to receive radiation to these areas after breast cancer surgery. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for this trial?

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.

Do I need to stop my current medications for the trial?

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 is generally safe for breast cancer patients. In one study, more than half of the patients experienced no skin problems during treatment. Another study found low rates of short-term side effects and changes in appearance with this method. Patients typically handle hypofractionated therapy well.

Overall, hypofractionated radiation therapy has a strong safety record, with a low risk of side effects and effective cancer control. For those considering joining a trial, this treatment has been well-researched and is often well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring different schedules of radiation therapy for breast cancer because these approaches could significantly improve treatment efficiency and patient experience. Unlike the traditional radiation therapy that spans over five weeks, the hypofractionated radiation therapy option delivers the same therapeutic dose in just three weeks. This shorter schedule not only reduces the burden of frequent hospital visits but also maintains the effectiveness in targeting cancer cells. By potentially offering a faster, equally effective treatment option, this trial aims to enhance the quality of life for patients undergoing radiation therapy.

What evidence suggests that this trial's radiation therapy schedules could be effective for breast cancer?

Studies have shown that hypofractionated radiation therapy, which reduces treatment time to three weeks, effectively treats breast cancer. In this trial, some participants will receive hypofractionated regional nodal irradiation (RNI) over three weeks. One analysis found this method to be as safe and effective as the traditional five-week schedule, tested in another arm of this trial as standard regional nodal irradiation (RNI). Research also indicates that patients receiving the shorter therapy experience few side effects and maintain good cosmetic results. This treatment delivers the same total amount of radiation in less time, offering more convenience for patients. Overall, hypofractionated radiation therapy appears to be a promising option for shortening treatment time without losing effectiveness. ^{1 3 5 6 7}

Who Is on the Research Team?

Karen E. Hoffman

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with invasive breast cancer who are planning or have had surgery and recommend radiation to lymph nodes near the breast. They must not be pregnant, have no other active cancers, and should not have received certain prior treatments that overlap with this study's area.

Inclusion Criteria

My breast cancer was confirmed by a lab test and fits specific stage criteria.

I had or will have breast surgery and checked my lymph nodes, with or without postoperative radiation.

I am 18 or older and will receive radiation therapy after surgery.

Exclusion Criteria

I had breast cancer in my other breast before and am now getting radiation after surgery.

My cancer has spread to distant parts of my body.

I have invasive breast cancer in the opposite breast and am receiving preoperative radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo either hypofractionated RNI for 3 weeks or standard RNI for 5 weeks, followed by an additional boost dose of radiation therapy

3-5 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with arm measurements and questionnaires

Up to 126 months

Visits at 3 and 6 months, then every 6 months up to 2.5 years, and yearly until 10.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hypofractionated Radiation Therapy
• Radiation Therapy

Trial Overview The trial tests if a shorter 3-week course of radiation therapy to the lymph nodes is as effective in preventing cancer recurrence as the conventional 5-week course. It also examines side effects like arm swelling.

How Is the Trial Designed?

Group I: Arm I: Hypofractionated Regional Nodal Irradiation (RNI) Experimental Treatment 4 Interventions

Patients undergo hypofractionated RNI in 15 fractions 5 consecutive days a week for 3 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.

Group II: Arm II: Standard Regional Nodal Irradiation (RNI) Active Control 4 Interventions

Patients undergo standard RNI in 25 fractions 5 consecutive days a week for 5 weeks. Patients also undergo additional boost dose of radiation therapy in 5 or 7 fractions on consecutive days following completion of RNI.

Hypofractionated Radiation Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in European Union as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

Approved in Canada as Hypofractionated Radiotherapy for:

• Soft tissue sarcoma
• Extremity soft tissue sarcoma

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

A study involving 188 breast cancer patients compared different radiation therapy schedules and found that hypofractionated radiation (completed in 2-3 weeks) is as effective as conventional radiation (5 weeks) in terms of locoregional control and toxicity.

Both treatment regimens showed similar rates of skin toxicity and no major chronic side effects, suggesting that hypofractionated radiation is a safe and convenient alternative that can reduce treatment time and healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conventional Versus Different Hypofractionated Radiotherapy Dosage Schedules in Postmastectomy Advanced Breast Cancer. Jain, N., Sharma, R., Sachdeva, K., et al.[2022]

Hypofractionated radiotherapy is gaining popularity for breast cancer treatment in the UK and Canada, but there are concerns about potential increased toxicity associated with this approach.

The article emphasizes the importance of careful planning and dosimetry in hypofractionated radiotherapy to ensure effective treatment while minimizing risks, and it provides recommendations for both planning and monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the minimal standards of radiotherapy planning and dosimetry for "hypofractionated" radiotherapy in breast cancer? MacLeod, N., McIntyre, A., Canney, PA.[2018]

In a study of 252 early-stage breast cancer patients, surface-guided radiation therapy (SGRT) significantly improved patient positioning accuracy by an average of 5.3 points compared to conventional skin markers, indicating its effectiveness in ensuring precise radiation delivery.

SGRT demonstrated a high correlation with the surgical clips in the tumor bed, achieving over 99% accuracy in matching positions, which helps to minimize unnecessary radiation exposure during treatment verification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surface-guided radiation therapy for breast cancer: more precise positioning. González-Sanchis, A., Brualla-González, L., Fuster-Diana, C., et al.[2021]

Hypofractionated radiation therapy, which delivers fewer but larger doses of radiation over a shorter period, has shown comparable outcomes to conventional radiation in treating breast cancer, suggesting it could be an effective alternative.

Ongoing phase 3 trials are investigating hypofractionated whole breast irradiation and accelerated partial breast irradiation, which may lead to broader acceptance of these methods for early-stage breast cancer, although concerns about patient selection and late toxicity remain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiation therapy in the treatment of early-stage breast cancer. Freedman, GM.[2021]

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 393 breast cancer patients treated with moderately hypofractionated radiotherapy (HYPO-RT) over a median follow-up of 5.7 years, the overall survival rates were high at 96.0% at 5 years and 79.3% at 10 years, indicating the efficacy of this treatment.

HYPO-RT demonstrated excellent local control with only 4.3% local recurrences and low toxicity rates, with severe acute dermatitis occurring in just 0.9% of patients, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy in breast cancer: a 10-year single institution experience. Najas, GF., Stuart, SR., Marta, GN., et al.[2022]

In a phase II study involving 40 high-risk prostate cancer patients, dose-escalated hypofractionated radiotherapy (hfrt) combined with androgen suppression therapy was found to be feasible, delivering 75 Gy in 25 fractions with minimal acute gastrointestinal and genitourinary toxicities.

Only 16.6% of patients experienced grade 2 genitourinary toxicity and 12.9% experienced gastrointestinal toxicity, indicating that the treatment can be administered safely while still targeting the pelvic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity of hypofractionated intensity-modulated radiotherapy for prostate cancer. Drodge, CS., Boychak, O., Patel, S., et al.[2018]

Hypofractionated radiotherapy, particularly accelerated partial breast irradiation, is increasingly recommended for women with low local relapse risk breast cancer, as it offers a more targeted treatment option.

The abstract highlights the limitations of intraoperative irradiation while emphasizing the advantages of alternative techniques like brachytherapy and 3D-conformal accelerated partial breast irradiation, suggesting a need for careful consideration of treatment modalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Debate about breast cancer: "Cons: Intraoperative radiotherapy"]. Bourgier, C., Heymann, S., Verstraet, R., et al.[2011]

Modern radiation therapy techniques, such as hypofractionated regimens and partial breast irradiation, have significantly reduced treatment times for breast and prostate cancer, improving patient convenience and maintaining high local tumor control rates.

Single-fraction stereotactic radiotherapy for bone metastases offers effective pain relief and long-lasting tumor control, demonstrating the efficacy of shorter treatment protocols in enhancing patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Smarter Medicine in Radiation Oncology - current and proven treatment concepts offering the greatest possible benefit to cancer patients in clinical practice]. Zimmermann, F., Eberhardt, AL., Förster, R., et al.[2021]

The study evaluated an automated radiotherapy treatment planning algorithm for hypofractionated whole-breast irradiation in 99 patients, showing that the automated plans were generated much faster (5-6 minutes) compared to manual plans (1-1.5 hours).

The automated plans demonstrated similar or superior dosimetric quality, particularly in sparing the ipsilateral lung, while maintaining effective treatment coverage, indicating strong potential for clinical application in breast cancer radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Hypofractionated IMRT treatment planning for early-stage breast Cancer. Lin, TC., Lin, CY., Li, KC., et al.[2021]

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]

Hypofractionated radiation therapy (HypoRT) was found to be effective in treating inoperable advanced non-small cell lung cancer (NSCLC), with an overall response rate of 83% among 30 patients, and a median follow-up of 13 months.

The treatment was well-tolerated, with manageable acute toxicities; however, 37% of patients experienced locoregional recurrence, and 57% developed distant metastasis, indicating the need for further studies to compare HypoRT with conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. Osti, MF., Agolli, L., Valeriani, M., et al.[2018]

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/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 ...

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/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 ...

5. ascopubs.org ascopubs.org/doi/10.1200/GO-24-00277

Phase II Evaluation of Ultra-Hypofractionated ... The study found that ultra-hypofractionated radiation therapy in patients with breast cancer had low rates of acute toxicity and cosmesis changes.

6. 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 ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34670727/

Hypofractionated Radiation Therapy (HFRT) of Breast ... Conclusion: Given the excellent local control, survival rates and the low toxicity profile demonstrated, HFRT could be considered a valid therapeutic option in ...