Shortened Radiotherapy for Post-Mastectomy Breast Cancer

Overseen By Simon Powell, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Endocrine therapies

Must not be taking: Concomitant anti-neoplastic

Disqualifiers: Distant metastasis, Pregnancy, Prior radiation, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see whether providing radiation on a shortened (compressed) schedule of 5 days in a row is a safe and effective approach to prevent cancer from coming back in people who have had a mastectomy.

Will I have to stop taking my current medications?

The trial does not require you to stop taking all your current medications. You can continue taking endocrine therapies (like tamoxifen or aromatase inhibitors), anti-HER2 therapy, and bisphosphonates during the trial. However, any other anti-cancer treatments should be completed at least 2 weeks before starting the trial.

What data supports the effectiveness of the treatment Radiotherapy, Radiation therapy, X-ray therapy, External beam radiation therapy for post-mastectomy breast cancer?

Research shows that radiotherapy is an important treatment for breast cancer, especially after surgery, as it helps prevent cancer from coming back. Shortened radiation therapy has been found to be as effective and safe as traditional longer treatments, which can make it easier for patients to access and complete their therapy. ^{1 2 3 4 5}

Is shortened radiotherapy for post-mastectomy breast cancer safe?

Radiotherapy, including shortened forms, is generally safe but can have side effects like heart issues and changes in breast appearance. Efforts are being made to reduce these risks, and modern techniques aim to minimize complications while maintaining effectiveness. ^{6 7 8 9 10}

How is shortened radiotherapy different from other treatments for post-mastectomy breast cancer?

Shortened radiotherapy for post-mastectomy breast cancer is unique because it offers a more convenient and less time-consuming treatment schedule compared to traditional radiotherapy, which typically lasts 5-7 weeks. This approach aims to maintain effectiveness while reducing the burden on patients. ^{2 3 11 12 13}

Research Team

Aftif Khan, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 30 with certain stages of breast cancer (Stage IIa - IIIa) who've had a mastectomy and possibly chest wall reconstruction. They should be in good physical condition, not pregnant or breastfeeding, without distant metastasis or prior radiation to the breast/thorax area. People with uncontrolled conditions like infections or diabetes, connective tissue diseases, or an active second malignancy are excluded.

Inclusion Criteria

My breast cancer is at an early but not the earliest stage.

I have had a mastectomy and am undergoing or have completed chest wall reconstruction.

I am 30 years old or older.

Exclusion Criteria

I am willing and able to follow the study's requirements and understand its risks.

My breast cancer has not spread to specific advanced stages.

I do not have an active cancer other than non-melanoma skin cancer, or it's at very low risk of coming back.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive post-mastectomy radiotherapy delivered using external beam RT techniques to a dose of 26 Gy in 5 fractions of 5.2 Gy delivered on consecutive weekdays, with an optional chest wall boost.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of regional and local recurrences and complications.

3 years

Treatment Details

Interventions

• Radiotherapy

Trial Overview The study is testing if a shortened schedule of radiation therapy—5 consecutive days—is effective and safe for preventing cancer recurrence after mastectomy in breast cancer patients. It's evaluating whether this compressed treatment can match traditional longer schedules.

Participant Groups

Group I: Post-Mastectomy Radiotherapy Experimental Treatment 1 Intervention

Treatment will consist of PMRT delivered using external beam RT techniques to a dose of 26 Gy in 5 fractions of 5.2 Gy delivered on consecutive weekdays with an optional chest wall boost of 5.2 Gy for 1-2 fractions or an alternate boost schedule of 2.5 Gy for 1-4 fractions at the discretion of the treating physician.

Radiotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in United States as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Canada as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Japan as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in China as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Approved in Switzerland as Radiation therapy for:

• Various cancers including breast cancer, lung cancer, prostate cancer, and soft tissue sarcoma

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Unconventional radiation therapy, which delivers larger doses over fewer days, does not increase the risk of local recurrence or negatively impact breast appearance in women with early breast cancer after breast-conserving surgery, based on a review of four trials involving 7095 participants.

This approach also significantly reduces acute skin toxicity, making it a safer option for selected patients, although long-term follow-up is needed to fully understand its effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fraction size in radiation treatment for breast conservation in early breast cancer. James, ML., Lehman, M., Hider, PN., et al.[2020]

In a review of 8228 women with early breast cancer, using altered radiation fraction sizes (larger doses over fewer days) did not significantly impact local recurrence-free survival, cosmetic outcomes, or overall survival compared to conventional radiation therapy.

However, altered fraction size was associated with reduced acute skin toxicity and less fatigue reported by patients, suggesting it may be a safer option without compromising treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fraction size in radiation therapy for breast conservation in early breast cancer. Hickey, BE., James, ML., Lehman, M., et al.[2022]

Radiotherapy has become a crucial treatment for breast cancer, especially after mastectomy, as it helps reduce the risk of recurrence in selected patients.

The approach to radiotherapy has evolved from being an additional treatment after surgery to a primary method aimed at preserving both the appearance and function of the breast.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The history of radiotherapy of breast cancer]. Ohkawa, T.[2006]

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]

Radiotherapy is a common and important treatment for early-stage breast cancer (Stage I-II), and recent studies have focused on its effectiveness when combined with various surgical approaches and chemotherapy.

The review also highlights the role of radiotherapy in managing post-mastectomy cases and locoregional relapses, as well as its application in treating more advanced forms of breast cancer, such as locally advanced and inflammatory types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Radiotherapy and breast cancer. A review of the literature]. Scarpati, D., Corvo, R., Franzone, P., et al.[2006]

Radiotherapy plays a crucial role in treating breast cancer, but it also poses potential cardiac risks that have been increasingly recognized in recent years.

The abstract indicates that while the risks to the heart from radiation are well-known, advancements in radiotherapy techniques have addressed these concerns, suggesting ongoing improvements in patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Toxicity after Radiotherapy for Breast Cancer: Myths and Facts. Nitsche, M., Pahl, R., Huber, K., et al.[2020]

In a review of radiation dose-effect relationships for early breast cancer treatment, a procedure involving lumpectomy and postoperative radiotherapy (46 Gy with a 9 Gy electron boost) was performed on 51 patients since 1987, resulting in good local control of the cancer.

The study concludes that the benefits of using radiotherapy in conservative treatment for early breast cancer significantly outweigh any potential drawbacks, leading to satisfactory cosmetic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Conservative surgery and radiotherapy of early breast cancer]. Okawa, T., Haga, S., Kajiwara, T., et al.[2011]

Modern breast cancer radiotherapy focuses on improving cure rates while minimizing late side effects like chronic pain, poor cosmetic outcomes, and cardiac toxicity.

Phase III studies are currently evaluating various techniques for partial breast irradiation, such as intra-operative single doses and hypo-fractionated brachytherapy, to determine their effectiveness compared to standard whole breast irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated partial breast irradiation: technically feasible but who will benefit? Ross, G.[2018]

Women who receive thoracic radiotherapy before the age of 30 have a significantly increased lifetime risk of developing breast cancer compared to the general population, highlighting the importance of monitoring this group.

It is recommended that these patients begin annual screening with mammography and MRI eight years after treatment or at age 25, whichever is later, to detect potential secondary tumors early and manage treatment effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer after thoracic radiotherapy in young patients: what does the radiologist need to know? Lago, BM., Bello, SDS., Gondim, GRM., et al.[2023]

Radiotherapy following conservation surgery significantly reduces the risk of local relapse and mortality in early breast cancer, confirming its critical role in treatment.

The review highlights the need to balance the effectiveness of radiotherapy with the minimization of side effects, particularly cosmetic issues, cardiac complications, and pulmonary side effects, which can arise from treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of radiotherapy-induced late complications in early breast cancer: the role of intensity-modulated radiation therapy and partial breast irradiation. Part I--normal tissue complications. Coles, CE., Moody, AM., Wilson, CB., et al.[2022]

Adjuvant breast radiation therapy after breast conservation surgery significantly reduces the risk of local recurrence and may improve overall survival, highlighting its importance in breast cancer treatment.

Recent literature supports the use of shorter radiation courses, which offer greater convenience and reduced time commitment for patients, while image-guided techniques are being utilized to enhance the precision of radiation delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of Adjuvant Radiation in Breast Conservation Therapy: Can We Minimize without Compromise? Edwards-Bennett, SM., Correa, CR., Harris, EE.[2022]

Post-mastectomy radiotherapy (PMRT) has shown benefits for patients with tumors smaller than 5 cm and one to three positive lymph nodes, but recent studies suggest that patient selection should be more individualized based on factors like age and lymph node characteristics.

The upcoming SUPREMO trial, set to release results in 2023, aims to provide clearer guidelines for PMRT use, potentially incorporating genomic profiling to better stratify patient risk and treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postmastectomy radiotherapy in T1-2 patients with one to three positive lymph nodes - Past, present and future. Kaššák, F., Rossier, C., Picardi, C., et al.[2020]

Radiation therapy (RT) is crucial in breast cancer treatment as it helps eliminate remaining cancer cells after surgery, significantly lowering the chances of local recurrence and improving survival rates for early-stage patients.

The article discusses various RT techniques, including hypofractionated RT and partial breast irradiation, highlighting their effectiveness in both noninvasive and invasive breast cancer cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation therapy in the management of breast cancer. Yang, TJ., Ho, AY.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Fraction size in radiation treatment for breast conservation in early breast cancer. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Fraction size in radiation therapy for breast conservation in early breast cancer. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

[The history of radiotherapy of breast cancer]. [2006]

4. Canada pubmed.ncbi.nlm.nih.gov

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

5. Italy pubmed.ncbi.nlm.nih.gov

[Radiotherapy and breast cancer. A review of the literature]. [2006]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiac Toxicity after Radiotherapy for Breast Cancer: Myths and Facts. [2020]

7. Japan pubmed.ncbi.nlm.nih.gov

[Conservative surgery and radiotherapy of early breast cancer]. [2011]

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

Accelerated partial breast irradiation: technically feasible but who will benefit? [2018]

9. Brazil pubmed.ncbi.nlm.nih.gov

Breast cancer after thoracic radiotherapy in young patients: what does the radiologist need to know? [2023]

10. England pubmed.ncbi.nlm.nih.gov

Reduction of radiotherapy-induced late complications in early breast cancer: the role of intensity-modulated radiation therapy and partial breast irradiation. Part I--normal tissue complications. [2022]

11. Egypt pubmed.ncbi.nlm.nih.gov

Optimization of Adjuvant Radiation in Breast Conservation Therapy: Can We Minimize without Compromise? [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Postmastectomy radiotherapy in T1-2 patients with one to three positive lymph nodes - Past, present and future. [2020]

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

Radiation therapy in the management of breast cancer. [2018]