Shortened Radiotherapy for Post-Mastectomy Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Aftif Khan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

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

Approved in 6 Jurisdictions

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.

Trial 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 (Radiation Therapy)

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 Canada, Japan, China, Switzerland for the following indications:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York, NY

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1998

Patients Recruited

602,000+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation treatment for breast cancer. Recent advances. Chow, E.[2018]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]