Radiation Therapy Schedules for Breast Cancer

Recruiting at 3 trial locations

Overseen By Vijayalakshmi Nagaraj, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Previous radiation, Extensive DCIS, 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: 1

Duration: 1 week

350 Participants Needed

Trial Summary

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.

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

Research shows that using fewer, larger doses of radiation (hypofractionation) for breast cancer can be as effective and safe as the traditional method of many smaller doses. Studies have found that these schedules provide similar levels of tumor control with comparable or even lower risk of side effects. ^{1 2 3 4 5}

Is radiation therapy with fewer, larger doses safe for breast cancer patients?

Research shows that using fewer, larger doses of radiation therapy is generally safe for breast cancer patients. Studies involving thousands of women have confirmed the safety of these schedules, with careful adjustments to the total dose to minimize side effects. ^{2 3 6 7 8}

How does the radiation therapy schedule in this trial differ from standard treatments for breast cancer?

This trial explores a unique radiation therapy schedule for breast cancer, using fewer but larger doses (600 cGy x 5 or 800 cGy x 3) compared to the standard 25 fractions of 2.0 Gy over 5 weeks. This approach, known as hypofractionation, aims to reduce treatment time and potentially improve patient convenience while maintaining effectiveness. ^{1 2 3 9 10}

What is the purpose of this trial?

Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.

Research Team

Silvia C Formenti, M.D.

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for post-menopausal women who have had a segmental mastectomy for Stage 1 breast cancer with negative margins and no lymph node involvement. Candidates must not have had previous radiation to the affected breast or a high proportion of DCIS indicative of EIC in their biopsy.

Inclusion Criteria

My breast cancer was removed with clear margins.

My cancer has not spread to nearby lymph nodes.

I am a post-menopausal woman who has had part of my breast removed.

Exclusion Criteria

I have had radiation therapy on the same side breast before.

My biopsy shows a significant amount of DCIS, indicating extensive intraductal cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 600 cGy x 5 fractions over 5 consecutive days or 800 cGy x 3 fractions every other day for 3 days

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

1 visit (1 month post-treatment), then every 6 months for the first year, then yearly for the next 10 years

Treatment Details

Interventions

• Arm 1 600 cGY x 5 fractions
• Arm 2 800 cGY x 3 fractions

Trial Overview The study compares two radiation treatments for breast cancer: one group receives 600 cGy over five days, while the other gets 800 cGy every other day, completing treatment within a week. Patients will be monitored regularly up to ten years after treatment.

Participant Groups

Group I: Arm 2 - 800 cGY x 3 fractions Experimental Treatment 1 Intervention

Patients will receive 800 cGY x 3 fractions of radiation therapy every other day for 3 days.

Group II: Arm 1 - 600 cGY x 5 fractions Experimental Treatment 1 Intervention

Patients will receive 600 cGY x 5 fractions of radiation therapy over 5 consecutive days.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). [2022]

2. Italy pubmed.ncbi.nlm.nih.gov

Dose fractionation and biological optimization in breast cancer. [2018]

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

Effect of radiotherapy fraction size on tumour control in patients with early-stage breast cancer after local tumour excision: long-term results of a randomised trial. [2022]

4. Belgium pubmed.ncbi.nlm.nih.gov

[Hypofractionated postoperative radiotherapy for breast cancer]. [2018]

5. China pubmed.ncbi.nlm.nih.gov

[Post-mastectomy radiotherapy with different fractionated dose schemes in early breast cancer]. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Hypofractionated adjuvant whole breast radiotherapy: progress and prospects. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of 26 Gy in five fractions over 1 week adjuvant radiotherapy for breast cancer: Prospective report of acute skin toxicity and consideration of resource implications. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of Efficacy and Toxicity of Hypo-fractionated Radiotherapy in Breast Carcinoma. [2020]

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

The UK Standardisation of Breast Radiotherapy (START) Trial B of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. [2022]