Radiation Therapy Schedules for Breast Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal schedule for radiation therapy in treating early-stage breast cancer. Researchers are testing two treatment plans to determine which is more effective: one delivers radiation over five days (Arm 1: 600 cGY x 5 fractions), while the other spreads it over three days with breaks in between (Arm 2: 800 cGY x 3 fractions). The trial targets post-menopausal women who have undergone a lumpectomy for small breast cancers that have not spread to lymph nodes. Participants will be monitored for up to 10 years to track treatment outcomes. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the 600 cGy x 5 fractions radiation therapy is generally safe and well-tolerated. Studies have found excellent safety outcomes, with low rates of side effects. Patients experienced minimal immediate negative reactions, known as acute toxicity. Long-term results also demonstrated good cosmetic outcomes, with few lasting changes to the appearance of the treated area.

For the 800 cGy x 3 fractions radiation therapy, studies indicate the possibility of some skin reactions. However, this treatment is effective and requires less time than traditional methods. While some skin discomfort may occur, the overall risk of severe side effects remains relatively low.

Both treatments are under study for their ability to safely deliver radiation in fewer sessions, potentially reducing treatment time. Participants should weigh the possibility of minor skin issues against the convenience and potential benefits of these treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiation therapy schedules for breast cancer because they offer potentially faster and more convenient treatment options. Unlike traditional radiation therapy, which typically involves smaller doses over several weeks, Arm 1 delivers 600 cGY across five consecutive days, while Arm 2 uses 800 cGY over just three sessions every other day. This condensed schedule could mean less time in treatment and a quicker return to daily life for patients. Additionally, the higher dose per session could enhance treatment effectiveness, making these schedules a promising alternative to existing lengthy protocols.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that both radiation therapy schedules tested in this trial hold promise for treating breast cancer. Participants in Arm 1 will receive 600 cGy in 5 sessions. Specifically, a previous study demonstrated that 99.5% of patients did not experience cancer recurrence within five years, with minimal side effects, enhancing quality of life. Participants in Arm 2 will receive 800 cGy in 3 sessions. Studies suggest that fewer, larger doses can be as effective as traditional methods, offering similar cancer control. This schedule has been associated with a 16% reduced risk of cancer returning over 10 years. Both treatments aim to manage breast cancer effectively while minimizing side effects. ^{1 3 6 7 8}

Who Is on the Research Team?

Silvia C Formenti, M.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879850021002253

Five-Fraction Prone Accelerated Partial Breast Irradiation Five-year local recurrence-free, disease-free, and overall survival was 99.5%, 96.7%, and 98.1%, respectively. When comparing patients with IBTR versus without, ...

2. redjournal.org redjournal.org/article/S0360-3016(23)04760-0/abstract

Effectiveness and Toxicity of Five Fraction Prone ... Five-fraction APBI delivered primarily in the prone position either daily or every other day was effective with low rates of local recurrence, minimal toxicity ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/85/NCT02276885/Prot_SAP_000.pdf

Official Title: Prone partial breast irradiation (PBI) 600 cGy X 5 fractions, over 5 consecutive days (arm 1) or. 800 cGy X ... Gy X 5 fractions, with respect to the development of breast fibrosis.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa0906260

Long-Term Results of Hypofractionated Radiation Therapy ... We conducted a study to determine whether a hypofractionated 3-week schedule of whole-breast irradiation is as effective as a 5-week schedule.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11017153/

One versus three weeks hypofractionated whole breast ... Five-year local tumour incidence and normal tissue effects prevalence show 26 Gy in 5 fractions in 1 week is a safe and effective alternative to 40 Gy in 15 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8800131/

Safety of pre- or postoperative accelerated radiotherapy in ... Accelerated radiotherapy (RT) in 5 fractions allows to deliver NART in a very short time span and minimizes the delay of surgery and chemotherapy.

7. researchgate.net researchgate.net/publication/377208526_Effectiveness_and_toxicity_of_five-fraction_prone_accelerated_partial_breast_irradiation

Effectiveness and toxicity of five-fraction prone accelerated ... This study reports long-term oncologic and cosmetic outcomes. Methods We included patients receiving APBI 600 cGy × 5 fx delivered every other ...

8. 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.