Radiation Therapy Schedules for Breast Cancer

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

805 Participants Needed

Trial Summary

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.

What data supports the idea that Radiation Therapy Schedules for Breast Cancer is an effective treatment?

The available research shows that hypofractionated radiation therapy (HFRT) is effective for treating breast cancer. Studies indicate that HFRT is a standard treatment for early-stage breast cancer, providing good plan quality and effectiveness. It also offers a shorter treatment time compared to traditional methods, making it more convenient for patients. Additionally, modern radiation therapy techniques, like image-guided radiotherapy, ensure precise delivery, which helps in achieving high local tumor control and maintaining a good quality of life. These advancements make HFRT a reliable option for breast cancer treatment. ^{1 2 3 4 5}

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

Research shows that hypofractionated radiotherapy (HFRT) is effective for early-stage breast cancer, offering shorter treatment times with good local tumor control and quality of life. It is also used in other cancers like lung cancer, where it improves local control and survival rates. ^{1 2 3 4 5}

What safety data exists for radiation therapy schedules in breast cancer treatment?

Several studies provide safety data for hypofractionated radiation therapy (HFRT) in breast cancer treatment. Research indicates that HFRT is as effective and safe as conventional radiation therapy, with studies reporting on dosimetric outcomes, acute toxicity, and local control. For example, a study on post-mastectomy HFRT reported on normal tissue exposure and acute toxicity. Another study from New Zealand found HFRT to be effective with manageable acute toxicity in early breast cancer. Additionally, a 10-year single institution experience confirmed the safety and effectiveness of HFRT, noting both acute and late toxicities. These findings suggest that HFRT is a viable and safe option for breast cancer treatment, although concerns about toxicity still exist. ^{6 7 8 9 10}

Is hypofractionated radiotherapy safe for breast cancer patients?

Research shows that hypofractionated radiotherapy (HFRT) is generally safe for breast cancer patients, with studies indicating it has similar safety outcomes to traditional radiation therapy. Some concerns about side effects like skin, lung, and heart issues exist, but overall, HFRT is considered a safe option. ^{6 7 8 9 11}

Is Hypofractionated Radiation Therapy a promising treatment for breast cancer?

Yes, Hypofractionated Radiation Therapy is a promising treatment for breast cancer. It offers shorter treatment times and can be more convenient for patients. Studies have shown that it provides similar outcomes to traditional radiation therapy, making it a good option for many patients. ^{4 7 12 13 14}

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

Hypofractionated radiation therapy for breast cancer involves giving fewer but larger doses of radiation over a shorter period, which can be more convenient and cost-effective compared to traditional radiation schedules. It uses precise techniques like image-guided radiotherapy (IGRT) and surface-guided radiation therapy (SGRT) to ensure accurate delivery, potentially reducing side effects and improving outcomes. ^{4 7 12 13 14}

What is the purpose of this trial?

To compare how often cancer recurs (comes back) after 3 weeks of radiation compared to 5 weeks of radiation in patients who receive radiation therapy delivered to the lymph nodes near the breast. The side effects that can develop during or after radiation treatment, including how often arm swelling (edema) happens, will also be studied.

Research Team

Karen E. Hoffman

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Image guided hypofractionated 3-dimensional radiation therapy in patients with inoperable advanced stage non-small cell lung cancer. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Automated Hypofractionated IMRT treatment planning for early-stage breast Cancer. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Surface-guided radiation therapy for breast cancer: more precise positioning. [2021]

5. Switzerland 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]. [2021]

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

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

What are the minimal standards of radiotherapy planning and dosimetry for "hypofractionated" radiotherapy in breast cancer? [2018]

8. Australia pubmed.ncbi.nlm.nih.gov

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

9. Poland pubmed.ncbi.nlm.nih.gov

Hypofractionated radiotherapy in breast cancer: a 10-year single institution experience. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Acute toxicity of hypofractionated intensity-modulated radiotherapy for prostate cancer. [2018]

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

Dosimetric Comparison of Hypofractionated Regimen in Breast Cancer Using Two Different Techniques: Intensity-Modulated Radiation Therapy (IMRT) and Volumetric-Modulated Arc Therapy (VMAT). [2023]

12. India pubmed.ncbi.nlm.nih.gov

Conventional Versus Different Hypofractionated Radiotherapy Dosage Schedules in Postmastectomy Advanced Breast Cancer. [2022]

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

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

14. France pubmed.ncbi.nlm.nih.gov

[Debate about breast cancer: "Cons: Intraoperative radiotherapy"]. [2011]